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BackgroundApproximately 2.4 million children in the United States suffer from food-induced anaphylaxis, a condition that is annually responsible for over 200 deaths and 200,000 emergency room visits. As a result, caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns. ObjectiveIn this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management, mobile health, smartphone app intervention called Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy. MethodsThis pilot study uses qualitative work (Phase I) to inform a 4-week longitudinal randomized controlled trial (Phase II). In Phase I, 10 caregivers of children (≤18 years old) with established food allergy (≥1 year from diagnosis) will participate in semistructured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children (≤18 years old) with a newly diagnosed food allergy (≤90 days from diagnosis) will be randomized 2:1 to receive the FASST intervention (n=20) or control condition (basic app with educational resources; n=10). Process measures include feasibility, caregiver acceptability, adherence, and satisfaction. Outcome measures include caregiver fatigue, anxiety, depression, sleep, self-efficacy, and quality of life measured at baseline, week 4, and 3 months post study completion. ResultsPhase I study activities have been completed, and Phase II participant enrollment into the randomized controlled trial is expected to commence in 2021. ConclusionsWith limited readily available resources at their disposal, the results from this study have the potential to provide caregivers of children with a newly diagnosed food allergy a tool to help them self-manage and mitigate negative psychosocial factors during a critical time period in the caregiving/condition trajectory. Trial RegistrationClinicalTrials.gov Identifier NCT04512924: https://clinicaltrials.gov/ct2/show/NCT04512924 International Registered Report Identifier (IRRID)DERR1-10.2196/25805

BackgroundIndividuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions, are often physically deconditioned, and demonstrate high levels of physical inactivity. ObjectiveThe primary objective of this randomized controlled trial was to establish the feasibility of a mobile health (mHealth) physical activity exercise app for individuals with VLUs to improve lower leg function. MethodsIn a 6-week study, adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3. Participants were randomized 1:1 to receive evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature. The mHealth Conditioning Activities for Lower Leg Function app also provided automated educational and motivational messages and user reports. Foot movement on the VLU-affected leg was tracked by a Bluetooth-enabled triaxial accelerometer. The study was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to assess the feasibility of reach, adherence, acceptability, implementation, and maintenance. ResultsA total of 24 patients were recruited, enrolled, and randomized in the study. Most patients reported difficulty following the protocol for exercising and using the accelerometer and mobile phone and did not use the provider contact feature. However, all patients were adherent to the 6-week exercise program more than 85% of the time for duration, whereas 33% (8/24) of patients adhered more than 85% for the frequency of performing the exercises. Across the three exercise levels, adherence did not differ between the two groups. Confidence limits around the difference in proportions ranged from −0.4 to 0.7. Providers in FOOTFIT+ were inconsistent in checking participant progress reports because of lack of time from competing work commitments. The technology became outdated quickly, making maintenance problematic. Participants said they would continue to exercise their foot and legs and liked being able to follow along with the demonstrations of each level of exercise provided through the app. ConclusionsThe findings of this study suggest that despite initial interest in using the app, several components of the program as originally designed had limited acceptability and feasibility. Future refinements should include the use of more modern technology including smaller wearable accelerometers, mobile phones or tablets with larger screens, an app designed with larger graphics, automated reporting for providers, and more engaging user features. Trial RegistrationClinicalTrials.gov NTC02632695; https://clinicaltrials.gov/ct2/show/NCT02632695

Background: Mind-body interventions focused on intentional breathing and movement have been found to mitigate the negative effects of caregiving such as such as stress, psychosocial distress, and emotional distress associated for persons living with Alzheimer's disease and related dementias. Objective: The objective was to assess the feasibility and acceptability and preliminary impacts of our 12-week mind body intervention "Gentle Yoga and Yogic Breathing" for caregivers of persons living with dementia on health outcomes including mutuality, depression and anxiety, loneliness and social support, quality of life, and physical function. Methods: We conducted a single-group cohort study in which 20 caregivers were enrolled. Data were collected at baseline and at the 12-week post-intervention endpoint. Results: The intervention was acceptable; 75% (n = 15/20) completed the study; 16 completed post-study questionnaires. Very few experienced technical issues; 31% (n = 3) most commonly reported as poor internet connectivity, 75% (n = 12/16) perceived a health benefit, 88% (n = 14/16) perceived improved day-to-day mood, and 100% (n = 16/16) would recommend the intervention to other caregivers. Although there was minimal change from baseline to 12 weeks, for health outcomes, there were very small improvements noted in anxiety and overall health. There were no reported adverse events. Conclusion: The intervention was well received and is feasible and acceptable for future studies of stress and health management interventions for caregivers of persons living with dementia. Registered with https://www.ClinicalTrials.gov (NCT03853148). [ABSTRACT FROM AUTHOR]

Family caregivers of adults with Alzheimer's disease and related dementias (ADRD) are the fastest growing group of informal healthcare providers in the United States. These individuals experience high levels of stress and physical and psychosocial symptoms related to their caregiving role. We provided 20 ADRD caregivers (≥ 55 years of age) with training and access to a mobile health app for at-home practice of gentle yoga and yoga breathing exercises. Here, we report secondary outcomes, including changes in caregiver physical and mental function, burden, fatigue, sleep, and biological stress markers (salivary cortisol and 1,5-anhydroglucitol [1,5-AG] assays) from Baseline (Week 1) to Study End (Week 12). Self-reported questionnaire data were collected online via the Research Electronic Data Capture system, and biomarker data were collected via saliva samples. Results supported indications for slight improvement in outcomes of caregiving burden among ADRD caregivers using the gentle yoga and yoga breathing app. Furthermore, slight improvements in mental health were observed; the greatest gains were made by those reporting higher burden and having family members with more severe dementias. Findings indicate that those experiencing the greatest improvement in caregiver burden scores spent the most time doing gentle yoga and yoga breathing exercises. Salivary stress biomarkers moved in a favorable direction (decreased cortisol; increased 1,5-AG) among caregivers practicing the exercises most often. This is among the first studies of gentle yoga and yoga breathing exercises for relieving ADRD caregiver burden and the first we are aware of to incorporate stress biomarker measurement. [ABSTRACT FROM AUTHOR]

This trial compared skin blood flow, temperature and incidence of venous leg ulcers in patients with chronic venous disease using compression wraps and elevation pillows. Patients with CEAP C4 skin damage and C5 history of ulcers were randomly assigned to a cryotherapy intervention ( n = 138) or placebo cuff control ( n = 138) applied to the lower legs over 9 months. The time the ulcers healed prior to enrollment in the study for the cryotherapy group ranged from 1 to 2218 days ( n = 8, median = 32 days); for the control group, the range was 24 to 489 days ( n = 6, median = 390 days). There were no statistically significant blood flow changes measured in perfusion units with a laser Doppler flowmetre within or between the groups; mean difference between the groups was 0·62, P = 0·619. No differences were noted in skin temperature measured with an infrared thermometer within and between the groups; mean difference between the groups was −0·17°C, P = 0·540. Cryotherapy did not improve skin blood flow or temperature and did not show efficacy in preventing ulcers. However, at least 30% of intervention and 50% of control participants were anticipated to develop an ulcer during the study; only ∼7% occurred. These findings suggest that strict adherence to standard of care decreases the incidence of leg ulcers and remains a best practice for leg ulcer prevention. [ABSTRACT FROM AUTHOR]

Background: For intervention studies that require the use of participant self-reports, the quality and accuracy of recorded data and variability in participant adherence rates to the treatment can cause significant outcome bias. Purpose: To assess the quality and accuracy of participant documentation of daily self-monitoring of leg skin temperature, adherence to a graduated cooling treatment protocol to prevent venous leg ulcers, and the potential for bias in treatment effect in a randomized controlled trial that included a population with chronic venous disease. Methods: Individuals were randomized to a leg cooling intervention or placebo treatment group to daily self-monitor and record lower leg skin temperature over a 9-month period on monthly paper study logs. Returned study logs for the first 100 completed participants (n=54 cooling intervention, n=46 control) were reviewed for quality and accuracy. Adherence was determined from evaluating the accuracy of participant documentation. To examine potential outcome bias in treatment effect, mean between group and within group comparisons of the before and after treatment differences were conducted using an intention-to-treat (ITT) versus a modified intention-to-treat (mITT) analysis approach with an 85% accuracy cut-off rate. Data were collected in 2011-2014. Results: Of the expected 900 study logs, 91.8% (826/900) were returned and 8.2% (74/900) were not. Non-mutually exclusive main error types in returned documentation included: 59.2% (489/826) white-outs, cross-off and/or overwrites, 34.9% (288/826) entries omitted, 29.4% (243/826) no performance of daily self-monitoring, 28.7% (237/826) no performance of the treatment intervention per the prescribed protocol regime, 26.8% (221/826) extraneous data, 8.6% (71/826) suspected fabrication, and 7.6% (63/826) questionable validity. Under ITT analysis, 38.4% (346/900) of all returned logs were, 85% accurate, 25.0% (225/900) were 85%-99% accurate, and 36.6% (329/900) were 100% accurate. Mean overall participant adherence rates were: 22.0% at, 85% accuracy, 53.0% at 85%-99% accuracy, and 25.0% at 100% accuracy. Under the mITT analysis, 54.0% (483/900) of returned logs were deemed adherent with ≥85% accuracy. Conclusion: This study found good rates of adherence. Under ITT analysis, 78.0% of participants were deemed adherent to the study protocol with ≥85% accuracy in documenting daily self-monitoring of skin temperatures in response to a topically applied experimental cooling cuff intervention for the prevention of venous leg ulcers. [ABSTRACT FROM AUTHOR]

People with chronic venous disease are at high risk for developing venous leg ulcers. Inflammation is posited as a pathological factor for this chronic condition as evidenced by persistently elevated skin temperature. As part of a larger trial to test the effects of a cooling regimen on leg ulcer prevention, the objective of this preliminary study was to evaluate the first 30 days of intense daily cooling. Compared to a placebo control cuff, a gel cuff applied to the most severely affected lower leg skin for 30 min daily showed no statistically significant differences between temperatures taken in the home at baseline compared to those measured at the 1 month follow up visit. There were also no differences in temperatures noted between the two groups, although the temperatures in the treatment group were lower 30 min after treatment, an indication of adherence. There was no discernable decrease or increase in temperature at a given time point during the 30 day treatment period compared to the control group. It may be better to have patients monitor skin temperature on a daily basis and then apply the cuff as necessary, rather than requiring daily cooling based on baseline measurement. This “prn” approach may provide a sufficient cooling milieu to prevent escalation of inflammation and thwart ulcer occurrence or recurrence. Clinical trials registration # NCT01509599 . [ABSTRACT FROM AUTHOR]

Aims To explore factors at the family caregiver and nursing home administrative levels that may affect participation in a clinical trial to determine the efficacy of hand feeding vs. percutaneous gastrostomy tube feeding in persons with late-stage dementia. Background Decision-making regarding use of tube feeding vs. hand feeding for persons with late-stage dementia is fraught with practical, emotional and ethical issues and is not informed by high levels of evidence. Design Qualitative case study. Methods Transcripts of focus groups with family caregivers were reviewed for themes guided by behavioural theory. Analyses of notes from contacts with nursing home administrators and staff were reviewed for themes guided by an organizational readiness model. Data were collected between the years 2009-2012. Results Factors related to caregiver willingness to participate included understanding of the prognosis of dementia, perceptions of feeding needs and clarity about research protocols. Nursing home willingness to participate was influenced by corporate approval, concerns about legal and regulatory issues, and prior relationships with investigators. Conclusion Participation in rigorous trials requires lengthy navigation of complex corporate requirements and training competent study staff. Objective deliberation by caregivers will depend on appropriate recruitment timing, design of recruitment materials and understanding of study requirements. The clinical standards and policy environment and the secular trends there-in have relevance to the responses of people at all levels. [ABSTRACT FROM AUTHOR]

Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease associated with respiratory muscle weakness and activity-limiting symptoms such as dyspnea. Respiratory muscle strength training (RMST) is an empirically validated therapy to increase respiratory muscle strength. The theoretically-informed, technology-enhanced RESP-FIT intervention for COPD is a 6-week combined inspiratory and expiratory muscle strength training program with symptom measurement in real time via ecological momentary assessment (EMA)., Objectives: In addition to hypothesis generating purposes, the purpose of this randomized control pilot study was to explore whether observed effects (on symptoms, patient-reported outcomes, and respiratory muscle strength) support carrying out a future large-scale trial of RESP-FIT., Methods: Thirty adults with COPD were randomized to intervention (n=15) or control, with intervention group undergoing 6 weeks of mHealth-enhanced RMST. Daily symptom data were collected in real time over the 6-week intervention period using EMA., Results: Compared to the control group, participants in the intervention group reported decreased dyspnea and anxiety, increased happiness, and improved respiratory muscle strength (PIMax). However, reports of fatigue and sleep disturbance increased in the intervention group compared to the control group., Conclusion: Results support the hypothesis that the 6-week RESP-FIT program will improve respiratory muscle strength, emotional state (anxiety and happiness), and breathlessness in COPD but may contribute to fatigue, at least in the short-term. Future work is needed to determine efficacy of RESP-FIT, determine mechanisms of action on dyspnea and fatigue, and conduct within-subject comparisons of EMA data to explore individual or environmental fluctuations in COPD symptoms., (JCOPDF © 2024.)

Background: We aimed to determine whether monitoring skin temperature (Tsk) over recently healed venous leg ulcers (VLUs) can provide an objective approach to predicting reulceration. The cases presented in this article were part of a larger, multisite, 6-month randomized clinical trial of a cooling intervention to prevent ulcer recurrence among patients with chronic venous disease (CVD) and with recently healed VLUs., Cases: We report a series of four patients with CVD, three experienced VLU reulceration, and one case remained free of recurrence. Assessments of recurrence likelihood is based on daily patient Tsk self-reports using a handheld infrared (IR) thermometer and clinic visits using a combination digital and long-wave IR camera. All three cases with reulceration demonstrate a persistent 2°C above baseline average Tsk increase and a "dip-and-spike" pattern from -3°C to +5°C for several days prior to reulceration. In contrast, the patient who remained free of VLU recurrence showed a stable pattern of Tsk with minimal daily fluctuations. Thermal images showed Tsk of the affected extremity is warmer compared with the contralateral limb and increased between visits when ulcers recurred., Conclusion: Using IR devices to monitor Tsk among patients with CVD at risk of reulceration is an objective and reliable approach to detect changes over time. Consistent Tsk elevation over the affected area as compared to the contralateral limb and a "dip-and-spike" pattern may predict reulceration. Infrared devices showed effectiveness in detecting changes indicative of Tsk changes in recently healed leg skin over scar tissue after VLU healing., Competing Interests: The authors declare no conflicts of interests., (Copyright © 2024 by the Wound, Ostomy, and Continence Nurses Society.)

Introduction: This study will test the effectiveness of FIT Families (FIT), a multicomponent family-based behavioural intervention, against a credible attention control condition, Home-Based Family Support (HBFS). This protocol paper describes the design of a randomised clinical trial testing the efficacy of the FIT intervention. The protocol will assess the efficacy of FIT to improve health status in African American adolescents with obesity (AAAO) and their primary caregivers on primary (percent body fat) and secondary (physical activity, metabolic control, weight loss) outcomes and its cost-effectiveness., Methods: 180 youth/caregiver dyads are randomised into FIT or HBFS, stratified by age, gender and baseline per cent overweight. The proposed study follows a two condition (FIT, HBFS) by four assessment time points. Tests will be conducted to identify potential relationship of baseline demographic and clinical variables to our dependent variables and see whether they are balanced between groups. It is hypothesised that youth/caregiver dyads randomised to FIT will show significantly greater reductions in percent body fat over a 12-month follow-up period compared with AAAO receiving HBFS. Preliminary findings are expected by November 2023., Ethics: This protocol received IRB approval from the Medical University of South Carolina (Pro00106021; see 'MUSC IRB 106021 Main Approval.doxc' in online supplemental materials)., Dissemination: Dissemination activities will include summary documents designed for distribution to the broader medical community/family audience and submission of manuscripts, based on study results, to relevant peer-reviewed scientific high-impact journals., Trial Registration Number: NCT04974554., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Idiopathic pulmonary fibrosis (IPF) is a serious illness with an unpredictable disease course and survival rates comparable with some cancers. Patients with IPF suffer considerable symptom burden, declining quality of life, and high health care resource utilization. Patients and caregivers report many unmet needs, including a desire for more education regarding diagnosis and assistance with navigating disease trajectory. Compelling evidence suggests that palliative care (PC) provides an extra layer of support for patients with serious illness., Research Question: The purpose of this survey was to gain perspectives regarding PC for patients with IPF by board-certified pulmonologists in South Carolina (SC)., Study Design and Methods: A 24-item survey was adapted (with permission) from the Pulmonary Fibrosis Foundation PC Survey instrument. Data were analyzed and results are presented., Results: Pulmonologists ( n  = 32, 44%) completed the survey; 97% practice in urbanized settings. The majority agreed that PC and hospice do not provide the same service. There were varying views about comfort in discussing prognosis, disease trajectory, and addressing advance directives. Options for ambulatory and inpatient PC are limited and early PC referral does not occur. None reported initiating a PC referral at time of initial IPF diagnosis., Interpretation: Pulmonologists in SC who participated in this survey are aware of the principles of PC in providing comprehensive care to patients with IPF and have limited options for PC referral. PC educational materials provided early in the diagnosis can help facilitate and guide end-of-life planning and discussions. Minimal resources exist for patients in underserved communities., Competing Interests: No competing financial interests exist., (© Kathleen Oare Lindell et al., 2023; Published by Mary Ann Liebert, Inc.)