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Aim: We sought to understand how early adopters used pharmacogenomic (PGx) testing for treating depression and attention deficient hyperactivity disorder (ADHD). Patients & methods: We conducted a phone survey with prescribers who had previously ordered an Informed PGx (Progenity, Inc., MI, USA) test. Results: We identified 1037 prescribers in our sampling period. Respondents (n = 64) were predominantly female (61.5%) and in pediatrics (n = 42; 64.6%). PGx testing was used for multiple scenarios (mean 3.3 ± 1.6); the most common was after no response to medication was observed (80%; 51/64). Most respondents state that test results typically reveal an altered metabolizer status. Conclusion: PGx test results ordered by early adopters often reveal altered metabolizers which leads them to change the depression/ADHD medication regimen. Future work should evaluate the clinical utility of PGx testing for depression/ADHD treatment.

In this piece, we unraveled the multifaceted processes of understanding and communicating risks of technology research that involves human subjects. Through focusing on the history and importance of IRB and ethics committee oversight, we highlighted the importance of going beyond our moral obligations to conduct ethical research and pointed out the practical and logistical reasons for adhering to research ethics review procedures. We urged the critical need to think proactively, rather than retroactively, of what risks we introduce to study participants, including potential physical, emotional, social, legal, and economic harms. We also examined how information flows to external entities outside of the research process need special consideration. Finally, informed consent can be reframed as a process beyond receiving signatures for formal, liability purposes. It is an opportunity to communicate risks to participants, and to put into place strategies to mitigate those risks.

BACKGROUND Digital behavioral interventions have become increasingly popular for their ability to support patient diagnosis and treatment, chronic disease self-management, behavior change, and adherence to recommended care. However, digital intervention development is impeded by challenges such as limited technical skills, limited access to developers, and cost. The purpose of this study is to elicit in-depth qualitative feedback from intervention developers who have interest in digital behavioral interventions but lack programming skills regarding the barriers they experience and key considerations in the design and implementation of digital interventions. OBJECTIVE This study aims to understand barriers in the design and implementation of digital behavioral interventions, as well as to identify key considerations for researchers who are developing these interventions. METHODS We conducted semistructured qualitative interviews with 18 researchers who had experience either designing (but not coding) digital behavioral interventions or running research studies with them. Participants were a convenience sample of users of the Computerized Intervention Authoring System platform, an existing no-code development platform for building digital intervention content, and were recruited through either direct email solicitation or snowball sampling. All interviews were conducted and recorded over videoconference between February and April 2020. Recordings from interviews were transcribed and thematically analyzed by multiple coders. RESULTS Interviews were completed with 18 participants and lasted between 24 and 65 (mean 46.9, SD 11.3) minutes. Interviewees were predominantly female (17/18, 94%) and represented different job roles, ranging from researcher to project/study staff. Three key barriers in the development of digital behavior interventions were identified during interviews: lack of cross-disciplinary understanding; variability in recipients’ technology access, infrastructure, and literacy; and the idea that evidence-based in-person interactions do not translate directly to digital interactions. Interviewees identified several key considerations that interventionists learned to prioritize, which have the potential to overcome these barriers and lead to successful interventions. CONCLUSIONS Barriers in the development of digital behavioral interventions are often created by a lack of cross-disciplinary understanding, which can lead to difficulties conceptualizing interventions, unrealistic expectations in terms of cost, and confusion about the development process. Moreover, concerns about research study participant characteristics and access to technology, as well as the translation of in-person interventions to digital, are apparent. Appropriate training in how to work with software development teams may help future digital behavior intervention creators overcome these barriers and may lead to new, exciting innovations in this space.

Background Digital behavioral interventions have become increasingly popular for their ability to support patient diagnosis and treatment, chronic disease self-management, behavior change, and adherence to recommended care. However, digital intervention development is impeded by challenges such as limited technical skills, limited access to developers, and cost. The purpose of this study is to elicit in-depth qualitative feedback from intervention developers who have interest in digital behavioral interventions but lack programming skills regarding the barriers they experience and key considerations in the design and implementation of digital interventions. Objective This study aims to understand barriers in the design and implementation of digital behavioral interventions, as well as to identify key considerations for researchers who are developing these interventions. Methods We conducted semistructured qualitative interviews with 18 researchers who had experience either designing (but not coding) digital behavioral interventions or running research studies with them. Participants were a convenience sample of users of the Computerized Intervention Authoring System platform, an existing no-code development platform for building digital intervention content, and were recruited through either direct email solicitation or snowball sampling. All interviews were conducted and recorded over videoconference between February and April 2020. Recordings from interviews were transcribed and thematically analyzed by multiple coders. Results Interviews were completed with 18 participants and lasted between 24 and 65 (mean 46.9, SD 11.3) minutes. Interviewees were predominantly female (17/18, 94%) and represented different job roles, ranging from researcher to project/study staff. Three key barriers in the development of digital behavior interventions were identified during interviews: lack of cross-disciplinary understanding; variability in recipients’ technology access, infrastructure, and literacy; and the idea that evidence-based in-person interactions do not translate directly to digital interactions. Interviewees identified several key considerations that interventionists learned to prioritize, which have the potential to overcome these barriers and lead to successful interventions. Conclusions Barriers in the development of digital behavioral interventions are often created by a lack of cross-disciplinary understanding, which can lead to difficulties conceptualizing interventions, unrealistic expectations in terms of cost, and confusion about the development process. Moreover, concerns about research study participant characteristics and access to technology, as well as the translation of in-person interventions to digital, are apparent. Appropriate training in how to work with software development teams may help future digital behavior intervention creators overcome these barriers and may lead to new, exciting innovations in this space.

BACKGROUND Digital interventions have gained momentum in terms of behavioral health. However, owing to lacking standard approaches or tools for creating digital behavioral interventions, clinical researchers follow widely varying conceptions of how best to go about digital intervention development. Researchers also face significant cost-, time-, and expertise-related challenges in digital intervention development. Improving the availability of tools and guidance for researchers will require a thorough understanding of the motivations and needs of researchers seeking to create digital interventions. OBJECTIVE This study aims to understand the perceptions of behavioral researchers toward digital interventions, and inform the use of these interventions, by documenting the reasons why researchers are increasingly focusing their efforts on digital interventions and their perspectives on the perceived benefits that digital approaches can provide for researchers and intervention recipients. METHODS We conducted semistructured qualitative interviews with 18 researchers who had experience designing digital behavioral interventions or running studies with them. A convenience sample of interviewees was recruited from among users of the Computerized Intervention Authoring System platform, a web-based tool that facilitates the process of creating and deploying digital interventions in behavioral research. Interviews were conducted over teleconference between February and April 2020. Recordings from the interviews were transcribed and thematically analyzed by multiple coders. RESULTS Interviews were completed with 18 individuals and lasted between 24 and 65 (mean 46.9, SD 11.3) minutes. Interviewees were predominantly female (17/18, 94%) and represented different job roles, ranging from researcher to project or study staff. Four major themes came out of the interviews concerning the benefits of digital interventions for behavioral health: convenience and flexibility for interventionists and recipients, support for implementing evidence-based interventions with fidelity, scaling and improving access to interventions, and getting a foot in the door despite stigma and disenfranchisement. CONCLUSIONS Interviewees described a number of important potential benefits of digital interventions, particularly with respect to scientific rigor, scalability, and overcoming barriers to reaching more people. There are complex considerations with regard to translating behavior change strategies into digital forms of delivery, and interventionists make individual, sometimes unexpected, choices with minimal evidence of their relative effectiveness. Future research should investigate how behavioral researchers can be supported in making these choices toward usability, ease of access, and approachability of digital interventions. Our study underscores the need for authoring platforms that can facilitate the process of creating and deploying digital interventions to reach their full potential for interventionists and recipients alike.

Improving exercise capacity is a primary objective in COPD. Declines in exercise capacity result in reduced physical activity and health-related quality of life (HRQoL). Self-management interventions can teach patients skills and behaviours to manage their disease. Technology-mediated interventions have the potential to provide easily accessible support for disease self-management. We evaluated the effectiveness of a web-based self-management intervention, focused on physical activity promotion, on exercise capacity in COPD. This 6-month randomised controlled trial (NCT02099799) enrolled 153 persons with COPD at two US sites (VABoston, n=108; VABirmingham, n=45). Participants were allocated (1:1) to the web-based self-management intervention (physical activity promotion through personalised, progressive step-count goals, feedback, online COPD-related education and social support via an online community) or usual care. The primary outcome was exercise capacity (6-min walk distance (6 MWD)). Secondary outcomes included physical activity (daily steps per day), HRQoL (St. George's Respiratory Questionnaire Total Score), dyspnoea, COPD-related knowledge and social support. Change in step-count goals reflected intervention engagement. Participants' mean age was 69 (sd=7), and mean forced expiratory volume in 1 s % predicted was 61% (sd=21%). Change in 6MWD did not differ between groups. Intervention participants improved their mean daily step counts by 1312 more than those in the usual care group (p, A web-based self-management intervention improved physical activity but not exercise capacity. There is a need to develop and study accessible self-management interventions for COPD. https://bit.ly/3iT1yvU

Aim: We sought to explore how early adopters use pharmacogenomic (PGx) testing for treating depression and attention-deficit/hyperactivity disorder. Patients & methods: Prescribers of the Informed PGx (Progenity, Inc., Ann Arbor, MI 48108, USA) test completed a phone survey assessing use of PGx testing for different scenarios. We conducted a qualitative thematic text analysis of transcribed audio recordings of open-ended responses (n = 62). Results: PGx testing was used when treating multiple comorbidities or resistant disease, and to ease patients’ concerns with future therapy. Use of PGx testing is influenced by insurance coverage, interpretability of results and results turnaround time. Conclusion: Prescribers used PGx tests to modify medications for complex patients with depression, attention-deficit/hyperactivity disorder and other disorders to alleviate concerns related to adverse effects and lack of effectiveness.

BACKGROUND Despite current rehabilitation programs, long-term engagement in physical activity remains a significant challenge for patients with chronic obstructive pulmonary disease (COPD) and heart failure (HF). Novel strategies to promote physical activity in these populations are greatly needed. Emerging literature on the benefits of both mind–body interventions and web-based interventions provide the rationale for the development of the Mindful Steps intervention for increasing walking behavior. OBJECTIVE This study aims to develop a novel multimodal mind–body exercise intervention through adaptation of an existing web-based physical activity intervention and incorporation of mind–body exercise, and to pilot test the delivery of the new intervention, Mindful Steps, in a randomized controlled feasibility trial in older adults with COPD and/or HF. METHODS In phase 1, guided by a theoretical conceptual model and review of the literature on facilitators and barriers of physical activity in COPD and HF, we convened an expert panel of researchers, mind–body practitioners, and clinicians to inform development of the novel, multimodal intervention. In phase 2, we are conducting a pilot randomized controlled feasibility trial of the Mindful Steps intervention that includes in-person mind–body exercise classes, an educational website, online mind–body videos, and a pedometer with step-count feedback and goals to increase walking behavior in patients with COPD and/or HF. Outcomes include feasibility measures as well as patient-centered measures. RESULTS The study is currently ongoing. Phase 1 intervention development was completed in March 2019, and phase 2 data collection began in April 2019. CONCLUSIONS Through the integration of components from a web-based physical activity intervention and mind–body exercise, we created a novel, multimodal program to impact long-term physical activity engagement for individuals with COPD and HF. This developmental work and pilot study will provide valuable information needed to design a future clinical trial assessing efficacy of this multimodal approach. CLINICALTRIAL ClinicalTrials.gov NCT03003780; https://clinicaltrials.gov/ct2/show/NCT03003780 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/27826

Background Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many US veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective especially with personalized coaching support. We developed Stay Strong, a mobile app tailored to US veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and an app-based dashboard. We tested whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone. Objective The goal of this study is to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching. Methods Participants (n=357) were recruited from a national random sample of US veterans of recent wars and randomly assigned to the Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3 per week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal setting. All aspects of the enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months postbaseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation. Results The average age of participants was 39.8 (SD 8.7) years, and 25.2% (90/357) were female. Active Minutes decreased from baseline to 12 months for both groups (P Conclusions Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals, did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial’s 357 participants failed to sync their Fitbit device at 12 months and, thus, were lost to follow-up. Trial Registration ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 International Registered Report Identifier (IRRID) RR2-10.2196/12526

BACKGROUND Hypertension is a prevalent and costly burden in the United States. Clinical pharmacists within care teams provide effective management of hypertension, as does home blood pressure monitoring; however, concerns about data quality and latency are widespread. One approach to close the gap between clinical pharmacist intervention and home blood pressure monitoring is the use of mobile health (mHealth) technology. OBJECTIVE We sought to investigate the feasibility, acceptability, and preliminary effectiveness of BPTrack, a clinical pharmacist-led intervention that incorporates patient- and clinician-facing apps to make electronically collected, patient-generated data available to providers in real time for hypertension management. The patient app also included customizable daily medication reminders and educational messages. Additionally, this study sought to understand barriers to adoption and areas for improvement identified by key stakeholders, so more widespread use of such interventions may be achieved. METHODS We conducted a mixed methods pilot study of BPTrack, to improve blood pressure control in patients with uncontrolled hypertension through a 12-week pre-post intervention. All patients were recruited from a primary care setting where they worked with a clinical pharmacist for hypertension management. Participants completed a baseline visit, then spent 12 weeks utilizing BPTrack before returning to the clinic for follow-up. Collected data from patient participants included surveys pre- and postintervention, clinical measures (for establishing effectiveness, with the primary outcome being a change in blood pressure and the secondary outcome being a change in medication adherence), utilization of the BPTrack app, interviews at follow-up, and chart review. We also conducted interviews with key stakeholders. RESULTS A total of 15 patient participants were included (13 remained through follow-up for an 86.7% retention rate) in a single group, pre-post assessment pilot study. Data supported the hypothesis that BPTrack was feasible and acceptable for use by patient and provider participants and was effective at reducing patient blood pressure. At the 12-week follow-up, patients exhibited significant reductions in both systolic blood pressure (baseline mean 137.3 mm Hg, SD 11.1 mm Hg; follow-up mean 131.0 mm Hg, SD 9.9 mm Hg; P=.02) and diastolic blood pressure (baseline mean 89.4 mm Hg, SD 7.7 mm Hg; follow-up mean 82.5 mm Hg, SD 8.2 mm Hg; P CONCLUSIONS Results demonstrate that a pharmacist-led mHealth intervention promoting home blood pressure monitoring and clinical pharmacist management of hypertension can be effective at reducing blood pressure in primary care patients with uncontrolled hypertension. Our data also support the feasibility and acceptability of these types of interventions for patients and providers. CLINICALTRIAL ClinicalTrials.gov NCT02898584; https://clinicaltrials.gov/ct2/show/NCT02898584 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8059

BACKGROUND Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many US veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective especially with personalized coaching support. We developed Stay Strong, a mobile app tailored to US veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and an app-based dashboard. We tested whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone. OBJECTIVE The goal of this study is to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching. METHODS Participants (n=357) were recruited from a national random sample of US veterans of recent wars and randomly assigned to the Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3 per week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal setting. All aspects of the enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months postbaseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation. RESULTS The average age of participants was 39.8 (SD 8.7) years, and 25.2% (90/357) were female. Active Minutes decreased from baseline to 12 months for both groups (PP=.82) or 12 months (P=.98). However, at 12 months, many participants in both groups did not record Active Minutes, leading to missing data in 67.0% (120/179) for Stay Strong and 61.8% (110/178) for Stay Strong+Coaching. Average baseline weight for participants in Stay Strong and Stay Strong+Coaching was 214 lbs and 198 lbs, respectively, with no difference at baseline (P=.54) or at 6 months (P=.28) or 12 months (P=.18) postbaseline based on administrative weights, which had lower rates of missing data. Changes in the number of steps recorded and patient activation also did not differ by arm. CONCLUSIONS Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals, did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial’s 357 participants failed to sync their Fitbit device at 12 months and, thus, were lost to follow-up. CLINICALTRIAL ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 INTERNATIONAL REGISTERED REPORT RR2-10.2196/12526

Low physical activity is highly prevalent among COPD patients and is associated with increased healthcare utilization and mortality and reduced HRQL. The addition of a website to pedometer use is effective at increasing physical activity; however, the timeline of change and impact of environmental factors on efficacy is unknown.U.S. Veterans with COPD were randomized (1:1) to receive either (1) a pedometer and website which provided goal-setting, feedback, disease-specific education, and an online community forum or (2) pedometer alone for 3 months. Primary outcome was change in daily step count. Secondary outcomes included 6MWT distance, HRQL, dyspnea, depression, COPD knowledge, exercise self-efficacy, social support, motivation, and confidence to exercise. Generalized linear mixed-effects models evaluated the effect of the pedometer plus website compared to pedometer alone.Data from 109 subjects (98.5% male, mean age 68.6 ± 8.3 years) were analyzed. At 13 weeks, subjects in the pedometer plus website group had significant increases daily step count from baseline relative to the pedometer alone group (804 ± 356.5 steps per day, p = 0.02). The pedometer plus website group had significant improvements in daily step count from baseline beginning in week 3 which were sustained until week 13. In subgroup analyses, the pedometer plus website attenuated declines in daily step count during the transition from summer to fall. No significant differences in secondary outcomes were noted between groups.A website added to pedometer use improves daily step counts, sustains walking over 3 months, and attenuates declines in physical activity due to season.

Background Technology-based physical activity (PA) interventions have been shown to improve daily step counts and health-related quality of life, but their effect on long-term clinical outcomes like acute exacerbations (AEs) is unknown in persons with COPD. Methods U.S. Veterans with stable COPD were randomized (1:1) to either pedometer alone (control) or pedometer plus a website with feedback, goal-setting, disease education, and a community forum (intervention) for 3 months. AEs were assessed every 3 months over a follow-up period of approximately 15 months. Pedometer-assessed daily step counts, health-related quality-of-life (HRQL), and self-efficacy were assessed at baseline, end-of-intervention at 3 months, and during follow-up approximately 6 and 12 months after enrollment. Zero-inflated Poisson models assessed the effect of the intervention on risk for AEs, compared to controls. Generalized linear mixed-effects models for repeated measures examined between-group and within-group changes in daily step count, HRQL, and self-efficacy. Results There were no significant differences in age, FEV1% predicted, baseline daily step count, AEs the year prior to enrollment, or duration of follow-up between the intervention (n = 57) and control (n = 52) groups. The intervention group had a significantly reduced risk of AEs (rate ratio = 0.51, [95%CI 0.31–0.85]), compared to the control group. There were no significant between-group differences in change in average daily step count, HRQL, or self-efficacy at 6 and 12 months after enrollment. Conclusions A 3-month internet-mediated, pedometer-based PA intervention was associated with reduced risk for AEs of COPD over 12–15 months of follow-up. ClinicalTrials.gov identifier: NCT01772082.

BACKGROUND With the increasing adoption of electronic health record (EHR) systems, documentation-related burdens have been increasing for health care providers. Recent estimates indicate that primary care providers spend about one-half of their workdays interacting with the EHR, of which about half is focused on clerical tasks. To reduce documentation burdens associated with the EHR, health care systems and physician practices are increasingly implementing medical scribes to assist providers with real-time documentation. Scribes are typically unlicensed paraprofessionals who assist health care providers by documenting notes electronically under the direction of a licensed practitioner or physician in real time. Despite the promise of scribes, few studies have investigated their effect on clinical encounters, particularly with regard to patient-provider communication. OBJECTIVE The purpose of this quasi-experimental pilot study was to understand how scribes affect patient-physician communication in primary care clinical encounters. METHODS We employed a convergent mixed methods design and included a sample of three physician-scribe pairs and 34 patients. Patients’ clinical encounters were randomly assigned to a scribe or nonscribe group. We conducted patient surveys focused on perceptions of patient-provider communication and satisfaction with encounters, video recorded clinical encounters, and conducted physician interviews about their experiences with scribes. RESULTS Overall, the survey results revealed that patients across both arms reported very high satisfaction of communication with their physician, their physician’s use of the EHR, and their care, with very little variability. Video recording analysis supported patient survey data by demonstrating high measures of communication among physicians in both scribed and nonscribed encounters. Furthermore, video recordings revealed that the presence of scribes had very little effect on the clinical encounter. CONCLUSIONS From the patient’s perspective, scribes are an acceptable addition to clinical encounters. Although they do not have much impact on patients’ perceptions of satisfaction and their impact on the clinical encounter itself was minimal, their potential to reduce documentation-related burden on physicians is valuable. Physicians noted important issues related to scribes, including important considerations for implementing scribe programs, the role of scribes in patient interactions, how physicians work with scribes, characteristics of good scribes, and the role of scribes in physician workflow.

Background: With the increasing adoption of electronic health record (EHR) systems, documentation-related burdens have been increasing for health care providers. Recent estimates indicate that primary care providers spend about one-half of their workdays interacting with the EHR, of which about half is focused on clerical tasks. To reduce documentation burdens associated with the EHR, health care systems and physician practices are increasingly implementing medical scribes to assist providers with real-time documentation. Scribes are typically unlicensed paraprofessionals who assist health care providers by documenting notes electronically under the direction of a licensed practitioner or physician in real time. Despite the promise of scribes, few studies have investigated their effect on clinical encounters, particularly with regard to patient-provider communication. Objective: The purpose of this quasi-experimental pilot study was to understand how scribes affect patient-physician communication in primary care clinical encounters. Methods: We employed a convergent mixed methods design and included a sample of three physician-scribe pairs and 34 patients. Patients’ clinical encounters were randomly assigned to a scribe or nonscribe group. We conducted patient surveys focused on perceptions of patient-provider communication and satisfaction with encounters, video recorded clinical encounters, and conducted physician interviews about their experiences with scribes. Results: Overall, the survey results revealed that patients across both arms reported very high satisfaction of communication with their physician, their physician’s use of the EHR, and their care, with very little variability. Video recording analysis supported patient survey data by demonstrating high measures of communication among physicians in both scribed and nonscribed encounters. Furthermore, video recordings revealed that the presence of scribes had very little effect on the clinical encounter. Conclusions: From the patient’s perspective, scribes are an acceptable addition to clinical encounters. Although they do not have much impact on patients’ perceptions of satisfaction and their impact on the clinical encounter itself was minimal, their potential to reduce documentation-related burden on physicians is valuable. Physicians noted important issues related to scribes, including important considerations for implementing scribe programs, the role of scribes in patient interactions, how physicians work with scribes, characteristics of good scribes, and the role of scribes in physician workflow.

BACKGROUND Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. OBJECTIVE The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. METHODS We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. RESULTS We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. CONCLUSIONS This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care. CLINICALTRIAL ClinicalTrials.gov NCT03270891; https://clinicaltrials.gov/ct2/show/NCT03270891 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR1-10.2196/13848

Background Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. Objective The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. Methods We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. Results We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. Conclusions This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care. Trial Registration ClinicalTrials.gov NCT03270891; https://clinicaltrials.gov/ct2/show/NCT03270891 International Registered Report Identifier (IRRID) RR1-10.2196/13848

Estimates of the minimal clinically important difference (MCID) for physical activity (PA) in chronic obstructive pulmonary disease (COPD) are needed. The objective is to provide an anchor-based estimate of the MCID for daily step count. PA was promoted in persons with COPD using a pedometer (Omron HJ-720ITC) alone or a pedometer plus interactive website for 3 months. Participants wore the pedometer daily and received phone calls monthly to ascertain medical events. Medical events were counted when a participant self-reported that he/she had (1) worsening of breathing, (2) change to breathing medications, (3) medical care from an emergency room for any reason, or (4) hospitalization for any reason. Generalized linear regression models assessed daily step count as change at the end of study and averaged over the 15, 31, or 61 days centered on the event, in those with an event compared to those without one. All categories of events carried equal weight in the analyses. We studied 93 persons, 46 of whom had an event. Participants who experienced an event had a decrease of 1086 (95% confidence interval (CI): −2124 to −48) or 887 (95% CI: −2030 to 257) steps/day in the pedometer plus website or pedometer alone groups, respectively, compared to those without one. In the days centered on an event, participants who had an event experienced a decrease of 882–983 steps/day (pedometer plus website) or a decrease of 351–495 steps/day (pedometer alone), compared to those without one. The MCID for PA in COPD ranges from 350 steps/day to 1100 steps/day.

Background Despite current rehabilitation programs, long-term engagement in physical activity remains a significant challenge for patients with chronic obstructive pulmonary disease (COPD) and heart failure (HF). Novel strategies to promote physical activity in these populations are greatly needed. Emerging literature on the benefits of both mind–body interventions and web-based interventions provide the rationale for the development of the Mindful Steps intervention for increasing walking behavior. Objective This study aims to develop a novel multimodal mind–body exercise intervention through adaptation of an existing web-based physical activity intervention and incorporation of mind–body exercise, and to pilot test the delivery of the new intervention, Mindful Steps, in a randomized controlled feasibility trial in older adults with COPD and/or HF. Methods In phase 1, guided by a theoretical conceptual model and review of the literature on facilitators and barriers of physical activity in COPD and HF, we convened an expert panel of researchers, mind–body practitioners, and clinicians to inform development of the novel, multimodal intervention. In phase 2, we are conducting a pilot randomized controlled feasibility trial of the Mindful Steps intervention that includes in-person mind–body exercise classes, an educational website, online mind–body videos, and a pedometer with step-count feedback and goals to increase walking behavior in patients with COPD and/or HF. Outcomes include feasibility measures as well as patient-centered measures. Results The study is currently ongoing. Phase 1 intervention development was completed in March 2019, and phase 2 data collection began in April 2019. Conclusions Through the integration of components from a web-based physical activity intervention and mind–body exercise, we created a novel, multimodal program to impact long-term physical activity engagement for individuals with COPD and HF. This developmental work and pilot study will provide valuable information needed to design a future clinical trial assessing efficacy of this multimodal approach. Trial Registration ClinicalTrials.gov NCT03003780; https://clinicaltrials.gov/ct2/show/NCT03003780 International Registered Report Identifier (IRRID) DERR1-10.2196/27826

Background Hypertension is a prevalent and costly burden in the United States. Clinical pharmacists within care teams provide effective management of hypertension, as does home blood pressure monitoring; however, concerns about data quality and latency are widespread. One approach to close the gap between clinical pharmacist intervention and home blood pressure monitoring is the use of mobile health (mHealth) technology. Objective We sought to investigate the feasibility, acceptability, and preliminary effectiveness of BPTrack, a clinical pharmacist-led intervention that incorporates patient- and clinician-facing apps to make electronically collected, patient-generated data available to providers in real time for hypertension management. The patient app also included customizable daily medication reminders and educational messages. Additionally, this study sought to understand barriers to adoption and areas for improvement identified by key stakeholders, so more widespread use of such interventions may be achieved. Methods We conducted a mixed methods pilot study of BPTrack, to improve blood pressure control in patients with uncontrolled hypertension through a 12-week pre-post intervention. All patients were recruited from a primary care setting where they worked with a clinical pharmacist for hypertension management. Participants completed a baseline visit, then spent 12 weeks utilizing BPTrack before returning to the clinic for follow-up. Collected data from patient participants included surveys pre- and postintervention, clinical measures (for establishing effectiveness, with the primary outcome being a change in blood pressure and the secondary outcome being a change in medication adherence), utilization of the BPTrack app, interviews at follow-up, and chart review. We also conducted interviews with key stakeholders. Results A total of 15 patient participants were included (13 remained through follow-up for an 86.7% retention rate) in a single group, pre-post assessment pilot study. Data supported the hypothesis that BPTrack was feasible and acceptable for use by patient and provider participants and was effective at reducing patient blood pressure. At the 12-week follow-up, patients exhibited significant reductions in both systolic blood pressure (baseline mean 137.3 mm Hg, SD 11.1 mm Hg; follow-up mean 131.0 mm Hg, SD 9.9 mm Hg; P=.02) and diastolic blood pressure (baseline mean 89.4 mm Hg, SD 7.7 mm Hg; follow-up mean 82.5 mm Hg, SD 8.2 mm Hg; P Conclusions Results demonstrate that a pharmacist-led mHealth intervention promoting home blood pressure monitoring and clinical pharmacist management of hypertension can be effective at reducing blood pressure in primary care patients with uncontrolled hypertension. Our data also support the feasibility and acceptability of these types of interventions for patients and providers. Trial Registration ClinicalTrials.gov NCT02898584; https://clinicaltrials.gov/ct2/show/NCT02898584 International Registered Report Identifier (IRRID) RR2-10.2196/resprot.8059

BACKGROUND African Americans shoulder significant disparities related to hypertension (HTN), which is a serious public health problem in the city of Detroit, Michigan, where more than 80% of the population is African American. Connectivity through smartphones, use of home blood pressure (BP) monitoring, and newly developed mobile health (mHealth) interventions can facilitate behavioral changes and may improve long-term self-care for chronic conditions, but implementation of a combined approach utilizing these methods has not been tested among African American patients with uncontrolled HTN. Since African Americans are more likely than other racial or ethnic subgroups to utilize the emergency department (ED) for ambulatory care, this presents an opportunity to intervene on a population that is otherwise difficult to reach. OBJECTIVE The MI-BP app aims to reduce health disparities related to HTN in the community by employing a user-centered intervention focused on self-BP monitoring, physical activity, reduced sodium intake, and medication adherence. We seek to test the efficacy of MI-BP, an mHealth app for HTN self-management, on BP control (primary aim), physical activity, sodium intake, and medication adherence (secondary aim) in African Americans with HTN. This study also seeks to evaluate the cost-effectiveness of MI-BP when compared with usual care methods. METHODS This is a 1-year randomized controlled trial that will recruit individuals who have uncontrolled HTN from 2 EDs in the city of Detroit, with a planned sample size of 396 randomized participants. To be eligible for inclusion, potential participants must be African American, 25 to 70 years old, previously diagnosed with HTN, have a smartphone compatible with MI-BP, and have uncontrolled BP at triage and on repeat measurement at least 1-hour post triage vitals. Once a participant is deemed eligible, all study procedures and subsequent follow-up visits (8 in total) are conducted at the Wayne State University Clinical Research Service Center. We seek to determine the effect of MI-BP on BP for 1 year (using BP control and mean systolic BP as coprimary outcomes and physical activity, sodium intake, and medication adherence as secondary outcomes) compared with usual care controls. RESULTS Recruitment for this study began in January 2018. The study will continue through 2021. CONCLUSIONS As the first of its kind conducted in an ED setting, MI-BP was designed to document the efficacy and acceptability of a multicomponent mHealth approach to help African Americans with uncontrolled BP modify their lifestyle to better manage their HTN. We expect to lay the foundation to sustainably reduce HTN-related health disparities through better integration of multiple behavior self-monitoring and improve outcomes for those who traditionally rely on the ED for chronic disease care. CLINICALTRIAL ClinicalTrials.gov NCT02360293; http://clinicaltrials.gov/ct2/show/NCT02360293 INTERNATIONAL REGISTERED REPOR RR1-10.2196/12601

BACKGROUND Although maintaining a healthy weight and physical conditioning are requirements of active military duty, many US veterans rapidly gain weight and lose conditioning when they separate from active-duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but it is unclear how to optimize engagement over time. Personalized health coaching, either through tailored automated messaging or by individual health coaches, has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain, we developed Stay Strong, a mobile app that is tailored to veterans of recent conflicts and tracks physical activity monitored by Fitbit Charge 2 devices and weight measured on a Bluetooth-enabled scale. OBJECTIVE The goal of this study is to determine the effect of activity monitoring plus health coaching compared with activity monitoring alone. METHODS In this randomized controlled trial, with Stay Strong, a mobile app designed specifically for veterans, we plan to enroll 350 veterans to engage in an mHealth lifestyle intervention that combines the use of a wearable physical activity tracker and a Bluetooth-enabled weight scale. The Stay Strong app displays physical activity and weight data trends over time. Enrolled participants are randomized to receive the Stay Strong app (active comparator arm) or Stay Strong + Coaching, an enhanced version of the program that adds coaching features (automated tailored messaging with weekly physical activity goals and up to 3 telephone calls with a health coach—intervention arm) for 1 year. Our primary outcome is change in physical activity at 12 months, with weight, pain, patient activation, and depression serving as secondary outcome measures. All processes related to recruitment, eligibility screening, informed consent, Health Insurance Portability and Accountability Act authorization, baseline assessment, randomization, the bulk of intervention delivery, and outcome assessment will be accomplished via the internet or smartphone app. RESULTS The study recruitment began in September 2017, and data collection is expected to conclude in 2019. A total of 465 participants consented to participate and 357 (357/465, 77%) provided baseline levels of physical activity and were randomized to 1 of the 2 interventions. CONCLUSIONS This novel randomized controlled trial will provide much-needed findings about whether the addition of telephone-based human coaching and other automated supportive-coaching features will improve physical activity compared with using a smartphone app linked to a wearable device alone. CLINICALTRIAL ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 (Archived by WebCite at http://www.webcitation.org/75KQeIFwh) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12526

Determinants of change in physical activity and outcomes of physical activity promotion are unclear. In this secondary analysis of a randomised controlled trial of a physical activity intervention, we assess predictors of change in physical activity and the effects of increasing physical activity on chronic obstructive pulmonary disease (COPD) measures. Physical activity was promoted in 94 subjects with COPD using the Omron HJ-720ITC pedometer alone or the pedometer plus a website that provides goal setting, feedback, motivational and educational messages, and social support for 3 months. We assessed forced expiratory volume in 1 s (FEV1), 6-min walk test (6MWT) distance, depression, social support and markers of systemic inflammation (C-reactive protein (CRP) and interleukin (IL)-6). Data from both groups were combined and subjects categorised as responders (increased steps per day) or nonresponders (decreased steps per day). Linear regression models explored predictors of change in physical activity and assessed the effect of response on changes in COPD measures. The cohort of responders (n=62) and nonresponders (n=32) had mean FEV1 1.89±0.64 L (63±22% predicted). Baseline steps per day, diagnosis of depression, social support, oxygen use and season significantly predicted change in daily step count. Responders had increases in physical activity (2038 steps per day), FEV1 (308 mL) and 6MWT distance (43.6 m), and decreases in CRP (7.84 mg·L−1) and IL-6 (2.73 ng·mL−1) compared with nonresponders (p, History of depression, social support, oxygen use and season predict change in physical activity in COPD. Response to physical activity promotion is associated with improvements in lung function, exercise capacity and systemic inflammation. http://ow.ly/oOMA30kPGCE

Background Low physical activity (PA) is associated with adverse health outcomes independent of airflow limitation in COPD. Self-reported assessments are often limited to global estimates of PA and may not be directly translatable to patients' goals and motivations. We developed a task-oriented PA checklist and examined its performance relative to pedometer-assessed daily step count in two COPD cohorts. Methods Task-oriented daily physical activity (DPA) was assessed in two COPD cohorts using either interviewer-administered recall questionnaire (DPA-R, Cohort 1, n = 109) or a self-administered diary-format daily checklist (DPA-C, Cohort 2, n = 175). Daily step count was measured in both cohorts using the Omron HJ-720 ITC pedometer. Univariate associations between individual DPA items and [a] cross-sectional and [b] longitudinal change (Cohort 1) in daily step count were assessed using a Pearson's correlation. Composite scores comprised of individual DPA items with univariate association p-values Results Tasks associated with average daily step count in both cohorts included putting on shoes, showering, washing hair, walking for exercise, the frequency of walks >10 min, and walking on an incline (Pearson's rho range = 0.14–0.43). A composite score of these 6 DPA items demonstrated significant associations with baseline average daily step count in both cohorts (ρ = 0.5 & 0.47, Cohorts 1 & 2, respectively) and longitudinal change in daily step count (ρ = 0.46, Cohort 1). Conclusions Self-reported task-oriented assessments complement direct monitoring and have potential clinical utility in exercise counseling to increase PA among COPD patients. Trial registration ClinicalTrials.gov NCT01772082.

BACKGROUND Low levels of physical activity (PA) are associated with poor outcomes in people with COPD. Interventions to increase PA could improve outcomes. METHODS We tested the efficacy of a novel Internet-mediated, pedometer-based exercise intervention. Veterans with COPD (N = 239) were randomized in a 2:1 ratio to the (1) intervention group (Omron HJ-720 ITC pedometer and Internet-mediated program) or (2) wait-list control group (pedometer). The primary outcome was health-related quality of life (HRQL), assessed by the St. George's Respiratory Questionnaire (SGRQ), at 4 months. We examined the SGRQ total score (SGRQ-TS) and three domain scores: Symptoms, Activities, and Impact. The secondary outcome was daily step counts. Linear regression models assessed the effect of intervention on outcomes. RESULTS Participants had a mean age of 67 ± 9 years, and 94% were men. There was no significant between-group difference in mean 4-month SGRQ-TS (2.3 units, P = .14). Nevertheless, a significantly greater proportion of intervention participants than control subjects had at least a 4-unit improvement in SGRQ-TS, the minimum clinically important difference (53% vs 39%, respectively, P = .05). For domain scores, the intervention group had a lower (reflecting better HRQL) mean than the control group by 4.6 units for Symptoms ( P = .046) and by 3.3 units for Impact ( P = .049). There was no significant difference in Activities score between the two groups. Compared with the control subjects, intervention participants walked 779 more steps per day at 4 months ( P = .005). CONCLUSIONS An Internet-mediated, pedometer-based walking program can improve domains of HRQL and daily step counts at 4 months in people with COPD. TRIAL REGISTRY ClinicalTrials.gov ; No.: NCT01102777; URL: www.clinicaltrials.gov

Background: Hypertension (HTN) is a major public health concern in the United States given its wide prevalence, high cost, and poor rates of control. Multiple strategies to counter this growing epidemic have been studied, and home blood pressure (BP) monitoring, mobile health (mHealth) interventions, and referrals to clinical pharmacists for BP management have all shown potential to be effective intervention strategies. Objective: The purpose of this study is to establish feasibility and acceptability of BPTrack, a clinical pharmacist-led mHealth intervention that aims to improve BP control by supporting home BP monitoring and medication adherence among patients with uncontrolled HTN. BPTrack is an intervention that makes home-monitored BP data available to clinical pharmacists for use in HTN management. Secondarily, this study seeks to understand barriers to adoption of this intervention, as well as points of improvement among key stakeholders, so that larger scale dissemination of the intervention may be achieved and more rigorous research can be conducted. Methods: This study is recruiting up to 25 individuals who have poorly controlled HTN from a Family Medicine clinic affiliated with a large Midwestern academic medical center. Patient participants complete a baseline visit, including installation and instructions on how to use BPTrack. Patient participants are then asked to follow the BP monitoring protocol for a period of 12 weeks, and subsequently complete a follow-up visit at the conclusion of the study period. Results: The recruitment period for the pilot study began in November 2016, and data collection is expected to conclude in late-2017. Conclusions: This pilot study seeks to document the feasibility and acceptability of a clinical pharmacist-led mHealth approach to managing HTN within a primary care setting. Through our 12-week pilot study, we expect to lend support for this approach, and lay the foundation for translating this approach into wider-scale implementation. This mHealth intervention seeks to leverage the multidisciplinary care team already in place within primary care, and to improve health outcomes for patients with uncontrolled HTN. Trial Registration: Clinicaltrials.gov NCT02898584; https://clinicaltrials.gov/ct2/show/NCT02898584 (Archived by WebCite® at http://www.webcitation.org/6u3wTGbe6)

BACKGROUND Hypertension (HTN) is a major public health concern in the United States given its wide prevalence, high cost, and poor rates of control. Multiple strategies to counter this growing epidemic have been studied, and home blood pressure (BP) monitoring, mobile health (mHealth) interventions, and referrals to clinical pharmacists for BP management have all shown potential to be effective intervention strategies. OBJECTIVE The purpose of this study is to establish feasibility and acceptability of BPTrack, a clinical pharmacist-led mHealth intervention that aims to improve BP control by supporting home BP monitoring and medication adherence among patients with uncontrolled HTN. BPTrack is an intervention that makes home-monitored BP data available to clinical pharmacists for use in HTN management. Secondarily, this study seeks to understand barriers to adoption of this intervention, as well as points of improvement among key stakeholders, so that larger scale dissemination of the intervention may be achieved and more rigorous research can be conducted. METHODS This study is recruiting up to 25 individuals who have poorly controlled HTN from a Family Medicine clinic affiliated with a large Midwestern academic medical center. Patient participants complete a baseline visit, including installation and instructions on how to use BPTrack. Patient participants are then asked to follow the BP monitoring protocol for a period of 12 weeks, and subsequently complete a follow-up visit at the conclusion of the study period. RESULTS The recruitment period for the pilot study began in November 2016, and data collection is expected to conclude in late-2017. CONCLUSIONS This pilot study seeks to document the feasibility and acceptability of a clinical pharmacist-led mHealth approach to managing HTN within a primary care setting. Through our 12-week pilot study, we expect to lend support for this approach, and lay the foundation for translating this approach into wider-scale implementation. This mHealth intervention seeks to leverage the multidisciplinary care team already in place within primary care, and to improve health outcomes for patients with uncontrolled HTN. CLINICALTRIAL Clinicaltrials.gov NCT02898584; https://clinicaltrials.gov/ct2/show/NCT02898584 (Archived by WebCite® at http://www.webcitation.org/6u3wTGbe6)

Background Although maintaining a healthy weight and physical conditioning are requirements of active military duty, many US veterans rapidly gain weight and lose conditioning when they separate from active-duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but it is unclear how to optimize engagement over time. Personalized health coaching, either through tailored automated messaging or by individual health coaches, has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain, we developed Stay Strong, a mobile app that is tailored to veterans of recent conflicts and tracks physical activity monitored by Fitbit Charge 2 devices and weight measured on a Bluetooth-enabled scale. Objective The goal of this study is to determine the effect of activity monitoring plus health coaching compared with activity monitoring alone. Methods In this randomized controlled trial, with Stay Strong, a mobile app designed specifically for veterans, we plan to enroll 350 veterans to engage in an mHealth lifestyle intervention that combines the use of a wearable physical activity tracker and a Bluetooth-enabled weight scale. The Stay Strong app displays physical activity and weight data trends over time. Enrolled participants are randomized to receive the Stay Strong app (active comparator arm) or Stay Strong + Coaching, an enhanced version of the program that adds coaching features (automated tailored messaging with weekly physical activity goals and up to 3 telephone calls with a health coach-intervention arm) for 1 year. Our primary outcome is change in physical activity at 12 months, with weight, pain, patient activation, and depression serving as secondary outcome measures. All processes related to recruitment, eligibility screening, informed consent, Health Insurance Portability and Accountability Act authorization, baseline assessment, randomization, the bulk of intervention delivery, and outcome assessment will be accomplished via the internet or smartphone app. Results The study recruitment began in September 2017, and data collection is expected to conclude in 2019. A total of 465 participants consented to participate and 357 (357/465, 77%) provided baseline levels of physical activity and were randomized to 1 of the 2 interventions. Conclusions This novel randomized controlled trial will provide much-needed findings about whether the addition of telephone-based human coaching and other automated supportive-coaching features will improve physical activity compared with using a smartphone app linked to a wearable device alone. Trial registration ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 (Archived by WebCite at http://www.webcitation.org/75KQeIFwh). International registered report identifier (irrid) DERR1-10.2196/12526.

Background: African Americans shoulder significant disparities related to hypertension (HTN), which is a serious public health problem in the city of Detroit, Michigan, where more than 80% of the population is African American. Connectivity through smartphones, use of home blood pressure (BP) monitoring, and newly developed mobile health (mHealth) interventions can facilitate behavioral changes and may improve long-term self-care for chronic conditions, but implementation of a combined approach utilizing these methods has not been tested among African American patients with uncontrolled HTN. Since African Americans are more likely than other racial or ethnic subgroups to utilize the emergency department (ED) for ambulatory care, this presents an opportunity to intervene on a population that is otherwise difficult to reach. Objective: The MI-BP app aims to reduce health disparities related to HTN in the community by employing a user-centered intervention focused on self-BP monitoring, physical activity, reduced sodium intake, and medication adherence. We seek to test the efficacy of MI-BP, an mHealth app for HTN self-management, on BP control (primary aim), physical activity, sodium intake, and medication adherence (secondary aim) in African Americans with HTN. This study also seeks to evaluate the cost-effectiveness of MI-BP when compared with usual care methods. Methods: This is a 1-year randomized controlled trial that will recruit individuals who have uncontrolled HTN from 2 EDs in the city of Detroit, with a planned sample size of 396 randomized participants. To be eligible for inclusion, potential participants must be African American, 25 to 70 years old, previously diagnosed with HTN, have a smartphone compatible with MI-BP, and have uncontrolled BP at triage and on repeat measurement at least 1-hour post triage vitals. Once a participant is deemed eligible, all study procedures and subsequent follow-up visits (8 in total) are conducted at the Wayne State University Clinical Research Service Center. We seek to determine the effect of MI-BP on BP for 1 year (using BP control and mean systolic BP as coprimary outcomes and physical activity, sodium intake, and medication adherence as secondary outcomes) compared with usual care controls. Results: Recruitment for this study began in January 2018. The study will continue through 2021. Conclusions: As the first of its kind conducted in an ED setting, MI-BP was designed to document the efficacy and acceptability of a multicomponent mHealth approach to help African Americans with uncontrolled BP modify their lifestyle to better manage their HTN. We expect to lay the foundation to sustainably reduce HTN-related health disparities through better integration of multiple behavior self-monitoring and improve outcomes for those who traditionally rely on the ED for chronic disease care. Trial Registration: ClinicalTrials.gov NCT02360293; http://clinicaltrials.gov/ct2/show/NCT02360293 International Registered Report Identifier (IRRID): RR1-10.2196/12601

Low levels of physical activity (PA) are associated with poor outcomes in people with COPD. Interventions to increase PA could improve outcomes.We tested the efficacy of a novel Internet-mediated, pedometer-based exercise intervention. Veterans with COPD (N = 239) were randomized in a 2:1 ratio to the (1) intervention group (Omron HJ-720 ITC pedometer and Internet-mediated program) or (2) wait-list control group (pedometer). The primary outcome was health-related quality of life (HRQL), assessed by the St. George's Respiratory Questionnaire (SGRQ), at 4 months. We examined the SGRQ total score (SGRQ-TS) and three domain scores: Symptoms, Activities, and Impact. The secondary outcome was daily step counts. Linear regression models assessed the effect of intervention on outcomes.Participants had a mean age of 67 ± 9 years, and 94% were men. There was no significant between-group difference in mean 4-month SGRQ-TS (2.3 units, P = .14). Nevertheless, a significantly greater proportion of intervention participants than control subjects had at least a 4-unit improvement in SGRQ-TS, the minimum clinically important difference (53% vs 39%, respectively, P = .05). For domain scores, the intervention group had a lower (reflecting better HRQL) mean than the control group by 4.6 units for Symptoms (P = .046) and by 3.3 units for Impact (P = .049). There was no significant difference in Activities score between the two groups. Compared with the control subjects, intervention participants walked 779 more steps per day at 4 months (P = .005).An Internet-mediated, pedometer-based walking program can improve domains of HRQL and daily step counts at 4 months in people with COPD.Clinical Trials.gov; No.: NCT01102777; URL: www.clinicaltrials.gov.

BackgroundChronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program. ObjectiveThe objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability. MethodsA parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points. ResultsBaseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant. ConclusionsIntervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements. Trial RegistrationClinicalTrials.gov NCT00694018; http://clinicaltrials.gov/ct2/show/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E).

Background: Regular physical activity (PA) is recommended for persons with chronic obstructive pulmonary disease (COPD). Interventions that promote PA and sustain long-term adherence to PA are needed. Objective: We examined the effects of an Internet-mediated, pedometer-based walking intervention, called Taking Healthy Steps, at 12 months. Methods: Veterans with COPD (N=239) were randomized in a 2:1 ratio to the intervention or wait-list control. During the first 4 months, participants in the intervention group were instructed to wear the pedometer every day, upload daily step counts at least once a week, and were provided access to a website with four key components: individualized goal setting, iterative feedback, educational and motivational content, and an online community forum. The subsequent 8-month maintenance phase was the same except that participants no longer received new educational content. Participants randomized to the wait-list control group were instructed to wear the pedometer, but they did not receive step-count goals or instructions to increase PA. The primary outcome was health-related quality of life (HRQL) assessed by the St George’s Respiratory Questionnaire Total Score (SGRQ-TS); the secondary outcome was daily step count. Linear mixed-effect models assessed the effect of intervention over time. One participant was excluded from the analysis because he was an outlier. Within the intervention group, we assessed pedometer adherence and website engagement by examining percent of days with valid step-count data, number of log-ins to the website each month, use of the online community forum, and responses to a structured survey. Results: Participants were 93.7% male (223/238) with a mean age of 67 (SD 9) years. At 12 months, there were no significant between-group differences in SGRQ-TS or daily step count. Between-group difference in daily step count was maximal and statistically significant at month 4 (P

Background Chronic back pain is a significant problem worldwide and may be especially prevalent among patients receiving care in the U.S. Department of Veterans Affairs healthcare system. Back pain affects adults at all ages and is associated with disability, lost workplace productivity, functional limitations and social isolation. Exercise is one of the most effective strategies for managing chronic back pain. Yet, there are few clinical programs that use low cost approaches to help patients with chronic back pain initiate and maintain an exercise program. Methods/Design We describe the design and rationale of a randomized controlled trial to assess the efficacy of a pedometer-based Internet mediated intervention for patients with chronic back pain. The intervention uses an enhanced pedometer, website and e-community to assist these patients with initiating and maintaining a regular walking program with the primary aim of reducing pain-related disability and functional interference. The study specific aims are: 1) To determine whether a pedometer-based Internet-mediated intervention reduces pain-related functional interference among patients with chronic back pain in the short term and over a 12-month timeframe. 2) To assess the effect of the intervention on walking (measured by step counts), quality of life, pain intensity, pain related fear and self-efficacy for exercise. 3) To identify factors associated with a sustained increase in walking over a 12-month timeframe among patients randomized to the intervention. Discussion Exercise is an integral part of managing chronic back pain but to be effective requires that patients actively participate in the management process. This intervention is designed to increase activity levels, improve functional status and make exercise programs more accessible for a broad range of patients with chronic back pain. Trial Registration Number NCT00694018

Background Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD. Methods/Design This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps, an Internet-mediated walking program for Veterans with COPD. Taking Healthy Steps includes an uploading pedometer, a website, and an online community. Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm receives iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls are notified that they are enrolled, but that their intervention will start in one year; however, they keep the pedometer and have access to a static webpage. Discussion Participants include 239 Veterans (mean age 66.7 years, 93.7% male) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm; rural-living (45.2%); ever-smokers (93.3%); and current smokers (25.1%). Baseline mean St. George’s Respiratory Questionnaire Total Score was 46.0; 30.5% reported severe dyspnea; and the average number of comorbid conditions was 4.9. Mean baseline daily step counts was 3497 (+/- 2220). Veterans with COPD can be recruited to participate in an online walking program. We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy. Trial registration Clinical Trials.gov NCT01102777