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Objectives: This study aimed to evaluate the cost-effectiveness of the randomized clinical trial STEP-KOA (STepped Exercise Program for patients with Knee OsteoArthritis)., Methods: The trial included 230 intervention and 115 control participants from 2 Veterans Affairs (VA) medical centers. A decision tree simulated outcomes for cohorts of patients receiving arthritis education (control) or STEP-KOA (intervention), which consisted of an internet-based exercise training program (step 1), phone counseling (step 2), and physical therapy (step 3) according to patient's response. Intervention costs were assessed from the VA perspective. Quality of life (QOL) was measured using 5-level EQ-5D US utility weights. Incremental cost-effectiveness ratios (ICERs) were calculated as the difference in costs divided by the difference in quality-adjusted life-years (QALYs) between arms at 9 months. A Monte Carlo probabilistic sensitivity analysis was used to generate a cost-effectiveness acceptability curve., Results: The adjusted model found differential improvement in QOL utility weights of 0.042 (95% confidence interval 0.003-0.080; P=.03) for STEP-KOA versus control at 9 months. In the base case, STEP-KOA resulted in an incremental gain of 0.028 QALYs and an incremental cost of $279 per patient for an ICER of $10 076. One-way sensitivity analyses found the largest sources of variation in the ICER were the impact on QOL and the need for a VA-owned tablet. The probabilistic sensitivity analysis found a 98% probability of cost-effectiveness at $50 000 willingness-to-pay per QALY., Conclusions: STEP-KOA improves QOL and has a high probability of cost-effectiveness. Resources needed to implement the program will decline as ownership of mobile health devices increases., (Copyright © 2021 International Society for Pharmacoeconomics and Outcomes Research, Inc. Published by Elsevier Inc. All rights reserved.)

Posttraumatic stress disorder (PTSD) has been associated with accelerated progression of coronary heart disease (CHD). However, the underlying pathophysiological pathway has remained elusive and it is unclear whether there is a direct link between PTSD and CHD risk. This paper describes the methods of a randomized controlled trial developed to examine how changes in PTSD symptoms affect CHD disease pathways. One hundred twenty participants with current PTSD and who are free of known CHD will be randomized to receive either an evidence-based treatment for PTSD (Cognitive Processing Therapy; CPT) or a waitlist control (WL). Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction. The primary hypothesis is that individuals who show improvement in PTSD symptoms will show improvement in CHD risk biomarkers, whereas individuals who fail to improve or show worsening PTSD symptoms will have no change or worsening in CHD biomarkers. This study is expected to provide knowledge of the role of both the direct impact of PTSD symptoms on CHD risk pathways and the role of these systems as candidate mechanisms underlying the relationship between PTSD and CHD risk. Further, results will provide guidance on the utility of cognitive therapy as a tool to mitigate the accelerated progression of CHD in PTSD. Clinical Trials Registration: https://clinicaltrials.gov/ct2/show/NCT02736929; Unique identifier: NCT02736929., (Copyright © 2021 Elsevier Inc. All rights reserved.)

The "home time" measure is gaining appeal in evaluating outcomes for multiple patient populations including post-surgery or intervention and the last 6 months of life. Advancing the science of home time measures will require obtaining the perspectives of patients and caregivers to arrive at a population-based measure of quality of life. Additionally, measure development requires considerations of what care settings denote time away from home, observation period, and thresholds that are clinically significant. We explore examples and challenges from current research and our own experience. Being able to advance such measures could also inform payment models and policy design., (Copyright © 2020. Published by Elsevier Inc.)

Background: Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure., Methods: Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months., Results: Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m 2 ., Conclusions: Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice., (Published by Elsevier Inc.)

Background: Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk., Methods: Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics., Conclusion: Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions., Trial Registration: ClinicalTrials.gov identifier NCT01838226., (Published by Elsevier Inc.)

Background: Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management., Methods: Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index≥27kg/m 2 ) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs., Conclusions: Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes., (Copyright © 2017. Published by Elsevier Inc.)

Objective: We developed an online intervention to teach physicians both MI (addressed in outcomes paper) and the 5 A's (Ask, Advise, Assess, Assist, and Arrange) when discussing weight with overweight/obese adolescents., Methods: We audio recorded 527 encounters between adolescents and physicians and coded the 5 A's during weight/BMI discussions. Half of physicians were randomized to receive a tailored, intervention that included their own audio-recorded clips. To examine arm differences, we used multilevel linear mixed-effects models for sum of 5 A's and generalized estimating equations (GEE) models with a logit link for each of the A's separately., Results: Intervention arm physicians used more A's than control physicians (estimated difference=0.6; 95%CI(0.2,1.0);p=0.001). Intervention physicians used Assess (p=0.004), Assist (p=0.001) and Arrange (p=0.02) more when compared to control arm physicians., Conclusion: An online intervention increased physicians' use of the 5 A's when discussing weight with overweight adolescents. These results are promising as the online intervention improved performance for the three A's that are infrequently used (Assess, Assist, and Arrange) yet have the most impact., Practice Implications: A tailored online program can increase physicians' use of the 5 A's behavioral counseling approach in clinical practice with adolescents., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy., (Published by Elsevier Inc.)

Purpose: We tested whether an online intervention combined with a patient feedback report improved physicians' use of motivational interviewing (MI) techniques when discussing weight with overweight and obese adolescents., Methods: We randomized 46 pediatricians and family physicians and audio recorded 527 patient encounters. Half of the physicians received an individually tailored, online intervention. Then, all physicians received a summary report detailing patient's weight-related behaviors. We coded MI techniques and used multilevel linear mixed-effects models to examine arm differences. We assessed patients' motivation to change and perceived empathy after encounter., Results: We found arm differences in the Intervention Phase and the Summary Report Phase: Empathy (p < .001), MI Spirit (p < .001), open questions (p = .02), and MI consistent behaviors (p = .04). Across all three phases (Baseline, Intervention, and Summary Report), when physicians had higher Empathy scores, patients were more motivated to change diet (p = .03) and physical activity (p = .03). In addition, patients rated physicians as more empathic when physicians used more MI consistent techniques (p = .02)., Conclusions: An individually tailored, online intervention coupled with a Summary Report improved physicians' use of MI, which improved the patient experience., (Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: We examined effects of providing type 2 diabetes genetic risk feedback on controllability perceptions., Methods: This is a secondary analysis of a randomized controlled trial in which overweight/obese Veterans Affairs patients without diabetes received conventional type 2 diabetes risk counseling that included either (1) personalized diabetes genetic risk feedback (genetic risk arm) or (2) eye disease counseling (comparison arm). Perceived diabetes control, and dietary and physical activity self-efficacy were compared between study arms, and between the comparison arm and each of 3 DNA-based genetic risk levels., Results: Participants (N=531) were predominately male, middle-age, and African American. Immediately post-counseling, perceived diabetes control was higher for the genetic risk arm (risk levels combined) than the comparison arm (p=0.005). In analyses by genetic risk levels, low genetic risk participants reported higher perceived diabetes control than comparison participants (p=0.007). Immediately post-counseling, low genetic risk participants reported higher dietary self-efficacy in situations when mood is negative compared with controls(p=0.01). At 3 months, no differences in constructs were observed., Conclusion: Genetic risk feedback for diabetes has temporary effects on perceived controllability among patients with low genetic risk., Practice Implications: Clinicians and other stakeholders should consider the limited effects on behavior change of diabetes genetic risk feedback., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objectives: Excessive gestational weight gain (GWG) puts women and children at risk of obesity. We piloted an SMS-texting intervention to promote healthy GWG among overweight and obese women., Methods: We recruited 35 women and randomized them in a 2:1 fashion to: a tailored SMS-texting intervention (Preg CHAT) vs. a generic texting intervention (Txt4baby). Preg CHAT texts provided personalized feedback based on women's intake of sweetened beverages, fruits and vegetables, fast food, daily steps taken, and weight. We abstracted women's weights from charts and surveyed women at baseline and 32 weeks gestation., Results: Few women refused the study; many (30%) did not complete the study, however. Of those in the Preg CHAT arm, 86% responded to texts, and 80% said they would recommend this program to a friend. For women who completed the surveys (n=23), those in the Preg CHAT arm had a mean gain of 6 less pounds than women in the Txt4Baby arm (95% CI -15.9, 4.0; p=0.24)., Conclusions: This pilot study shows feasibility, acceptability, and potential efficacy of a low-intensity and disseminable intervention to help overweight and obese women reduce GWG., Practice Implications: An SMS texting program might help overweight women reduce excessive GWG., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: An explicit goal of Patient Aligned Care Teams (PACTs) within the Veterans Health Administration is to promote continuity of care in primary care clinics and thereby reduce Emergency Department (ED) utilization; however, there has been little research to guide PACTs on how to accomplish this., Objectives: The overall goal of this study is to examine the impact of a primary care-based nurse telephone support program [DISPO ED] on Veterans treated and released from the ED who are at high risk for repeat visits., Methods: This study is a two group randomized, controlled trial to evaluate DISPO ED for Veterans treated and released from the ED who are at high risk for repeat visits. We define high risk as those who have had an ED visit or hospitalization during the 6 month period before the index ED visit and have ≥2 chronic conditions. Veterans are randomized to nurse telephone support or usual care. The primary outcome is repeat ED use within 30 days; secondary outcomes are patient satisfaction with care and total costs., Discussion: The results of this randomized, controlled trial with an Effectiveness-Implementation Type I Hybrid design will be directly relevant to the care of more than 500,000 high risk patients seen in Veterans' Affairs Medical Center (VAMC) EDs annually. Results will also be informative to health systems outside VA aiming to reduce ED use through accountable care organizations., (Published by Elsevier Inc.)

Objective: Physicians' use of Motivational Interviewing (MI) techniques when discussing weight with adolescent patients is unknown., Methods: We coded audio-recorded encounters between 49 primary care physicians and 180 overweight adolescent patients. During weight discussions, we used the MITI 3.0 to assess: Empathy, MI Spirit, open-ended questions, reflections, MI consistent behaviors (e.g., praising) and MI inconsistent behaviors (e.g., confronting). We examined associations of patient and physician characteristics with (1) MI techniques, (2) time discussing weight, and (3) encounter time., Results: Physicians used more MI consistent techniques with female patients (p=0.06) and with heavier patients (p=0.02). Physicians with prior MI training also used more MI consistent techniques (p=0.04) and asked more open-ended questions (p=0.05). Pediatricians had a higher MI Spirit score than family physicians (p=0.03). Older patient age was associated with physicians spending less time discussing weight-related topics (p=0.04) and higher BMI percentile was associated with physicians spending more time discussing weight-related topics (p=0.01). Increased use of MI inconsistent techniques was associated with longer encounters (p=0.02)., Conclusion: Physicians' weight discussions vary based on adolescent and physician characteristics. Importantly, not using MI lengthened encounter time., Practice Implications: Physicians might consider using MI techniques more and attempt to use these equally with all adolescents., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Objective: To describe the theoretical basis, use, and satisfaction with Teen CHAT, an online educational intervention designed to improve physician-adolescent communication about healthy weight., Methods: Routine health maintenance encounters between pediatricians and family practitioners and their overweight adolescent patients were audio recorded, and content was coded to summarize adherence with motivational interviewing techniques. An online educational intervention was developed using constructs from social cognitive theory and using personalized audio recordings. Physicians were randomized to the online intervention or not, and completed post-intervention surveys., Results: Forty-six physicians were recruited, and 22 physicians were randomized to view the intervention website. The educational intervention took an average of 54min to complete, and most physicians thought it was useful, that they would use newly acquired skills with their patients, and would recommend it to others. Fewer physicians thought it helped them address confidentiality issues with their adolescent patients., Conclusion: The Teen CHAT online intervention shows potential for enhancing physician motivational interviewing skills in an acceptable and time-efficient manner., Practice Implications: If found to be effective in enhancing motivational interviewing skills and changing adolescent weight-related behaviors, wide dissemination will be feasible and indicated., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background: Despite recognition of the benefits associated with well-controlled diabetes and hypertension, control remains suboptimal. Effective interventions for these conditions have been studied within academic settings, but interventions targeting both conditions have rarely been tested in community settings. We describe the design and baseline results of a trial evaluating a behavioral intervention among community patients with poorly-controlled diabetes and comorbid hypertension., Methods: Tailored Case Management for Diabetes and Hypertension (TEACH-DM) is a 24-month randomized, controlled trial evaluating a telephone-delivered behavioral intervention for diabetes and hypertension versus attention control. The study recruited from nine community practices. The nurse-administered intervention targets 3 areas: 1) cultivation of healthful behaviors for diabetes and hypertension control; 2) provision of fundamentals to support attainment of healthful behaviors; and 3) identification and correction of patient-specific barriers to adopting healthful behaviors. Hemoglobin A1c and blood pressure measured at 6, 12, and 24 months are co-primary outcomes. Secondary outcomes include self-efficacy, self-reported medication adherence, exercise, and cost-effectiveness., Results: Of 377 randomized patients, 193 were allocated to the intervention and 184 to attention control. The cohort is balanced in terms of gender, race, education level, and income. The cohort's mean baseline hemoglobin A1c and blood pressure are above goal, and mean baseline body mass index falls in the obese range. Baseline self-reported non-adherence is high for diabetes and hypertension medications. Trial results are pending., Conclusions: If effective, the TEACH-DM intervention's telephone-based delivery strategy and nurse administration make it well-suited for rapid implementation and broad dissemination in community settings., (© 2013.)

A variety of diet approaches achieve moderate weight loss in many individuals. Yet, most diet interventions fail to achieve meaningful weight loss in more than a few individuals, likely due to inadequate adherence to the diet. It is widely conjectured that targeting the diet to an individual's food preferences will enhance adherence, thereby improving weight loss. This article describes the design considerations of a study protocol aimed at testing this hypothesis. The study is a 2-arm randomized trial recruiting 216 medical outpatients with BMI ≥30 kg/m(2) followed for 48 weeks. Participants in the experimental arm (Choice) select from two of the most widely studied diets for weight loss, a low-carbohydrate, calorie-unrestricted diet (LCD) or a low-fat, reduced-calorie diet (LFD). The participant's choice is informed by results from a validated food preference questionnaire and a discussion of diet options with trained personnel. Choice participants are given the option to switch to the other diet after three months, if desired. Participants in the Control arm are randomly assigned to follow one of the two diets for the duration of follow-up. The primary outcome is weight assessed every 2-4 weeks for 48 weeks. Secondary outcomes include adherence to diet by food frequency questionnaire and obesity-specific health-related quality of life. If assisting patients to choose their diet enhances adherence and increases weight loss, the results will support the provision of diet options to patients who desire weight loss, and bring us one step closer to remediating the obesity epidemic faced by our healthcare systems., (Published by Elsevier Inc.)

Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA) and can decrease pain and improve function. Given the expected rise in prevalence of knee OA and the associated demand for treatment, there is a need for models of care that cost-effectively extend PT services for patients with this condition. This manuscript describes a randomized clinical trial of a group-based physical therapy program that can potentially extend services to more patients with knee OA, providing a greater number of sessions per patient, at lower staffing costs compared to traditional individual PT. Participants with symptomatic knee OA (n = 376) are randomized to either a 12-week group-based PT program (six 1 h sessions, eight patients per group, led by a physical therapist and physical therapist assistant) or usual PT care (two individual visits with a physical therapist). Participants in both PT arms receive instruction in an exercise program, information on joint care and protection, and individual consultations with a physical therapist to address specific functional and therapeutic needs. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and the secondary outcome is the Short Physical Performance Test Protocol (objective physical function). Outcomes are assessed at baseline and 12-week follow-up, and the primary outcome is also assessed via telephone at 24-week follow-up to examine sustainability of effects. Linear mixed models will be used to compare outcomes for the two study arms. An economic cost analysis of the PT interventions will also be conducted., (Published by Elsevier Inc.)

Objective: Examine primary care physicians' use of counseling techniques when treating overweight and obese patients and the association with mediators of behavior change as well as change in nutrition, exercise, and weight loss attempts., Methods: We audio recorded office encounters between 40 physicians and 461 patients. Encounters were coded for physician use of selected counseling techniques using the Motivational Interviewing Treatment Integrity (MITI) scale. Patient motivation and confidence as well as Fat and Fiber Diet score (1-4), Framingham physical activity questionnaire (MET-minutes), and weight loss attempts (yes/no) were assessed by surveys. Generalized linear models were fit, including physician, patient, and visit level covariates., Results: Patients whose physicians were rated higher in empathy improved their Fat and Fiber intake 0.18 units (95% CI 0, 0.4). When physicians used "MI consistent" techniques, patients reported higher confidence to improve nutrition (OR 2.57, 95% CI 1.2, 5.7)., Conclusion: When physicians used counseling techniques consistent with MI principles, some of their patients' weight-related attitudes and behaviors improved., Practice Implications: Physicians may not be able to employ formal MI during a clinic visit. However, use of counseling techniques consistent with MI principles, such as expression of empathy, may improve patients' weight-related attitudes and behaviors., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Objective: Evidence suggests that physicians' use of motivational interviewing (MI) techniques helps patients lose weight. We assessed patient, physician, relationship, and systems predictors of length of weight-loss discussions and whether physicians' used MI techniques., Methods: Forty primary care physicians and 461 of their overweight or obese patients were audio recorded and surveyed., Results: Weight-related topics were commonly discussed (nutrition 78%, physical activity 82%, and BMI/weight 72%). Use of MI techniques was low. A multivariable linear mixed model was fit to time spent discussing weight, adjusting for patient clustering within physician. More time was spent with obese patients (p=.0002), by African American physicians (p=.03), family physicians (p=.02), and physicians who believed patients were embarrassed to discuss weight (p=.05). Female physicians were more likely to use MI techniques (p=.02); African American physicians were more likely to use MI-inconsistent techniques (p<.001)., Conclusion: Primary care physicians routinely counsel about weight and are likely to spend more time with obese than with overweight patients. Internists spend less time on weight. Patient and systems factors do not seem to influence physicians' use MI techniques., Practice Implications: All physicians, particularly, male and African American physicians, could increase their use of MI techniques to promote more weight loss among patients., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Objective: Capitalizing on spousal support may enhance the effectiveness of interventions for chronic disease management. However, couples-based interventions present logistical challenges. We describe our experience and lessons learned while recruiting couples into the Couples Partnering for Lipid-Enhancing Strategies (CouPLES) trial., Methods: This trial seeks to reduce serum low-density lipoprotein cholesterol levels using a couples-based intervention designed to help patients engage in self-management behaviors. We proposed enrolling 250 couples over 13 months., Results: Due to practical challenges that we encountered, recruitment and enrollment lasted 21 months. Those challenges included: travel to study site; effectively marketing the study; participant burden; and establishing eligibility criteria. By modifying our protocol to address these challenges, the recruitment rate increased from 12 to 33%., Conclusion: In the absence of trials identifying the most effective recruitment strategies, investigators may need to experiment, amending their protocol intermittently until target enrollment numbers are reached. The lessons we present may help researchers conducting couples-based interventions develop more effective protocols., Practice Implications: To achieve target enrollment numbers, researchers conducting couples-based interventions should consider minimizing travel to the study site; carefully crafting recruitment materials; budgeting more for participant incentives and staff effort; and limiting exclusion criteria. These practices may also enhance retention., (Published by Elsevier Ireland Ltd.)

Background: Osteoarthritis (OA) is a leading cause of disability among adults. Although self-management behaviors such as exercise and weight management can improve pain and function, these behaviors are vastly underutilized. There is a need to implement effective self-management programs among the growing number of adults with OA., Objectives: The Self-Management of OsteoArthritis (SeMOA) in Veterans Study examines a 12-month telephone-based OA self-management program in the primary care setting. This manuscript details the design, methodology, and advances of the SeMOA trial., Methods: Participants (N=519) with hip or knee OA are randomly assigned to one of three groups: OA self-management, health education (attention control), or usual care. The OA self-management group receives written and audio materials regarding OA care (including health behaviors, medical care, and interacting with health care providers). A health educator calls participants monthly to review these materials and provide support for developing individualized goals and action plans related to OA management. The health education group receives written and audio materials and monthly calls from a health educator discussing health issues unrelated to OA. Usual care involves no additional materials or phone calls. The primary outcome is change in the Arthritis Impact Measurement Scales-2 pain subscale from baseline to 12 months. Analysis of covariance models will compare changes in pain across study groups. The cost-effectiveness of the OA self-management program will also be assessed., Conclusion: SeMOA is one of the first to examine telephone-based delivery of OA self-management and one of few trials to target the primary care setting. This program has the potential for broad dissemination because it reduces both the costs and barriers that accompany in-person programs. This study will provide important information about its feasibility and effectiveness in a real-world clinical setting.

Objective: Characteristics that may influence participation in DNA banks are not well defined. The purpose of this study was to examine characteristics associated with participation in a DNA bank among veterans diagnosed with Amyotrophic Lateral Sclerosis (ALS)., Methods: Veterans who screened eligible for the National Registry of Veterans with ALS were initially contacted about the DNA Bank via telephone and then mailed a consent form. Registry participants were then categorized as consented for the DNA bank, actively refused, or passively refused (consent form not returned after >3 months and multiple reminders). The associations of consent status with age, gender, race, military branch, years of military service, VA health system use, and ALS Functional Rating Scale (ALSFRS) scores were examined., Results: Registry participants (N=1020) were 98% male, 9.5% non-white, and the mean age was 64.1 years. 61.1% of participants were current VA health system users, and the branches of service were: Army (46.1%), Navy (22.1%), Air Force (23.2%), and Marines (8.3%). A total of 14.7% of Registry participants refused DNA banking (9.4% active refusal, 5.3% passive refusal). Results from multivariable models indicated participants who were non-White, VA users, or had lower ALSFRS scores (reflecting poorer function) had higher odds of refusal. Race and VA use were associated with active refusal, while age and ALSFRS score were associated with passive refusal., Conclusion: Although the overall refusal rate for DNA banking was relatively low, we still found important differences in consent by race, VA use, and functional status in this cohort of veterans with ALS. Because differential participation in DNA banking may influence generalizability, further efforts are needed to understand and intervene to reduce these differences.

Objective: Although estrogens are thought to have a beneficial effect on menopausal symptoms, the role of estrogen in the etiology and treatment of depression in older women remains unclear. The authors examined the relationship between hormone therapy (HT) use and depressive symptom severity., Methods: Authors report the findings from a cross-sectional analysis of baseline data from the Improving Mood: Promoting Access to Collaborative Treatment (IMPACT) Study, using data from 1,160 women age 60 years and older., Results: Women who were taking HT were likely to be younger, White, married, and to have had at least some college education. They were also more likely to report good or better health and to have taken antidepressant medications in the past 3 months. Although HT use was associated with more severe depressive symptoms in the unadjusted analysis, it was not associated with depression severity in adjusted analyses. Although there was a trend for a differential effect of college education with HT use on depression scores, no significant interaction was found between HT and race., Conclusion: There was no evidence to suggest that women HT users differ from non-HT users in depressive symptom severity.