Feasibility and Preliminary Impact of a Web-Based Mind Body Intervention for Older Dementia Caregivers.

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).

Study protocol for clinical trial of the FIT Families multicomponent obesity intervention for African American adolescents and their caregivers: Next step from the ORBIT initiative.

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.

Pulmonologists' Perspectives on and Access to Palliative Care for Patients With Idiopathic Pulmonary Fibrosis in South Carolina.

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.

Self-Administered Gentle Yoga and Yoga Breathing Intervention Improves Burden and Stress Biomarkers in Caregivers of Persons Living with Dementia.

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.

Comparison of home-based palliative care delivered by community health workers versus usual care: research protocol for a pilot randomized controlled trial.

BACKGROUND: Research studies demonstrate that palliative care can improve patient outcomes such as quality of life, symptom burden and patient satisfaction with care (Gomes B, et al. Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database Syst Rev. 2013(6):CD00776) (World Health Organization. Palliative Care. Published 2020.). While 76% of patients who need palliative care live in limited-resource countries, access to high quality palliative services in these countries is minimal (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care (2nd ed). 2020.). In 2014 the Worldwide Hospice Palliative Care Alliance, with strong endorsement by the WHO, released the Palliative Care Toolkit to provide a training and implementation toolkit for empowering community members to deliver palliative care in resource poor settings (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care at the End of Life. Geneva, Switzerland 2014.). They encouraged researchers and public health practitioners to conduct rigorous evaluation of the toolkit in diverse settings and contexts. To address this need, we will conduct a pilot randomized controlled trial (RCT) to examine implementation and explore potential effect of an intervention based upon the Palliative Care Toolkit, as adapted and used by community health workers (CHWs) working with a cancer center in Kolkata, India to deliver home-based palliative care for rural patients. METHODS: Utilizing a randomized controlled trial design, intervention patients (n = 45) receive home-based palliative services (Pal-Care) delivered by community health workers (CHWs), with comparison against a control group of patients (n = 45) who receive usual cancer-center-based palliative services. Primary outcome measures include evaluation of CHW training outcomes, roles and responsibilities of the CHWS and how they assist patients, trial recruitment, stakeholder perceptions of the intervention, and fidelity to study protocol. Secondary outcomes measure patient self-report of health-related quality of life, symptom burden, palliative needs and patient care experience, outcomes The RE-AIM framework guides our evaluation plan to measure the reach, effectiveness, adoption, implementation and maintenance of the Pal-Care intervention (Gaglio B, et al. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013;103(6):e38?46.). Data will be analyzed in SAS. All measures will be evaluated overall and by patient age, gender and cancer type and by CHW caseload. DISCUSSION: Pal-Care is a RCT funded by the NCI to explore utilization of CHWs to deliver a home-based palliative care intervention built upon the WHO Palliative Care toolkit (PCT), as compared to a usual care control group. The long-term goal of this research is to develop an effective and sustainable model for delivering home-based palliative care for cancer patients in underserved areas. TRIAL REGISTRATION (TRN): ClinicalTrials.gov ID# NCT04972630.

Development and feasibility testing of an integrated PTSD and adherence intervention cognitive processing therapy-life steps (CPT-L) to improve HIV outcomes: Trial protocol.

Despite high rates of Post-Traumatic Stress Disorder (PTSD) in persons living with HIV (PLWH) and poor HIV-related health outcomes associated with PTSD, an effective evidence-based treatment for PTSD symptoms in PLWH does not exist. Negative reinforcement conceptual models posit that avoidant behavior (hallmark symptom of PTSD) demonstrated by PLWH with co-occurring PTSD can contribute to poor antiretroviral therapy (ART) adherence. However, research evaluating the impact of evidence-based treatment for PTSD among HIV infected populations on HIV outcomes is scarce. The Cognitive Processing Therapy (CPT) protocol is an evidence-based PTSD treatment that may address internalized stigma with targeted modifications and improve ART adherence and subsequent viral suppression through reduction of avoidant coping. This study will be the first pilot open-label randomized control trial (RCT) to test feasibility of an integrated evidence-based PTSD treatment (CPT) with an adherence intervention (Lifesteps) delivered in a Ryan White clinic to improve PTSD symptoms, adherence to ART, and retention in HIV care. Primary aims are to (1) conduct theater testing of the CPT and Lifesteps research protocol and evaluate acceptability (n = 12) and (2) deliver a modified CPT protocol (CPT-Lifesteps, or CPT-L) in 60 PLWH/PTSD exploring impact of CPT-L on PTSD symptoms and HIV outcomes compared to a Lifesteps + Standard of Care condition. This innovative research extends PTSD treatment approaches as a paradigm to reduce barriers to ART adherence. Findings of this innovative study are significant because they support the Undetectable = Untransmittable (U[bond, double bond]U) campaign and can help prevent the transmission of HIV infection through increased viral suppression.

Efficacy of a Self-managed Cooling Intervention for Pain and Physical Activity in Individuals With Recently Healed Chronic Venous Leg and Diabetic Foot Ulcers: A Randomized Controlled Trial.

PURPOSE: This aim of this study was to evaluate the clinical efficacy of a self-managed cooling intervention in individuals with recently healed venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) on pain reduction and physical activity improvement. DESIGN: A 6-month longitudinal randomized controlled trial. SUBJECTS AND SETTING: The sample comprised 140 individuals with previously healed VLU and DFU who received care in 3 outpatient wound centers in the Southeastern region of the United States. Participants were randomized to the MUSTCOOL or a placebo cooling patch intervention. METHODS: The cooling and placebo interventions comprised cooling or cotton-filled patch application to recently healed skin for 30 minutes, 3 times weekly plus standard of care including compression and leg elevation (participants with VLU) or therapeutic footwear and hygiene (participants with DFU) over a 6-month period. Pain severity and intensity were measured with the Brief Pain Inventory and physical activity with the International Physical Activity Questionnaire, which assessed metabolic equivalent of tasks (METs) in minutes per week. Minutes in walking time per week were assessed with an accelerometer. Data were descriptively analyzed for difference changes in scores from baseline to 6 months post-intervention. RESULTS: Data were analyzed for 81 participants randomized to cooling and placebo groups (VLUs, n = 26/29) and DFU (n = 12/16). Slight reductions in VLU pain severity (-0.5, -0.2) and interference (-0.4, -0.5) and minimal reductions in DFU pain severity (0, -0.1) and interference (0.4/0.1) were achieved. However, pain scores were low to moderate at baseline (mean 4, 0-10 with 10 worst pain possible) in both groups. For physical activity, the MET values showed low physical activity in both groups at baseline with slight improvements noted in VLU cooling and placebo groups (73/799) and DFU (1921/225), respectively. Walking time for the VLU groups improved by 1420/2523 minutes; the DFU groups improved 135/157 minutes, respectively. Findings for outcomes were not statistically significant within or between groups. CONCLUSIONS: Application of the cooling pack compared to placebo was minimally efficacious in reducing posthealing pain and improving function in this posthealed ulcer population. However for pain, scores were initially low; thus outcomes on pain, while lower, were marginal. TRIAL REGISTRATION: The study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156), https://clinicaltrials.gov/ct2/show/NCT02626156 .

Feasibility trial of an integrated treatment "Activate for Life" for physical and mental well-being in older adults.

BACKGROUND: Pain and fatigue are common chronic conditions faced by older adults. Integrated interventions to address pain and fatigue may therefore be particularly useful for older adults, especially those interventions that target mobility and psychosocial well-being. The present study describes feasibility and participant satisfaction for an integrated eHealth treatment to address pain and fatigue in a sample of older adults living in a low-income independent residence facility and their own homes in the community. METHODS: Three treatment combinations were compared in a randomized repeated measures design to determine if adding components of breathing retraining and behavioral activation to the existing Otago program (for strength and balance) affected feasibility and patient satisfaction. Specifically, 30 older adults were randomly allocated to: Arm1: the Otago alone (n = 10); Arm 2: Otago + Gentle Yoga and Yogic Breathing (n = 10); or Arm 3: Otago + Gentle Yoga and Yogic Breathing + Behavioral Activation (combination was named 'Activate for Life' n = 10). Feasibility measures included recruitment rate, session completion characteristics, and satisfaction with the program. CONCLUSION: Data from this study provide support for the feasibility of an integrated program to address physical and mental well-being of older adults. Future fully powered studies should now focus on assessment of clinical outcomes and refinement of individual components. TRIAL REGISTRATION: Registered in clinicaltrials.gov with the identifier: NCT03853148 .

Feasibility of RESP-FIT: Technology-Enhanced Self-Management Intervention for Adults with COPD.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is associated with substantial functional morbidity, including activity-limiting symptoms such as dyspnea and fatigue. Self-management interventions aid in symptomatic management of COPD and have been shown to produce positive outcomes on quality of life (QOL) and reduce hospital admissions. PURPOSE: The purpose of this randomized controlled longitudinal pilot study was to assess feasibility of the combined Respiratory Fitness (RESP-FIT) + Smartphone Airway Management System (SAMS) program, a 6-week, self-management, technology-enhanced respiratory muscle strength training (RMST) mHealth intervention. PATIENTS AND METHODS: Feasibility was assessed by evaluating recruitment, retention, acceptability, adherence, and safety data. Data were collected from 30 participants (15 in intervention group, 15 in control) at 3 time points (baseline, 6 weeks, and 14 weeks). The intervention group was requested to perform RMST at regular intervals during the week (5 breaths, 5 times a day, 5 days a week). Bluetooth enabled tracking was used to track training sessions. Data were analyzed using descriptive statistics. RESULTS: Recruitment was staggered for device usage and was completed in 57 weeks, with near 90% retention from baseline to end-of-intervention. Mobile application rating scale scores and interview data indicated moderate satisfaction. Participants completed 14,388 actions in the app. The most commonly used features were recording of daily symptoms via ecological momentary assessment (EMA) and tracking RMST if assigned to training sessions. Training days were successfully captured using EMA, but Bluetooth enabled training tracking was found to be not feasible. Overall, participants reported satisfaction with the RESP-FIT + SAMS mHealth intervention and found it acceptable. CONCLUSION: RESP-FIT is feasible and enables real-time COPD symptom assessment in the home environment, but additional work is needed to integrate Bluetooth technology into the platform. Ongoing investigations focus on the accuracy of symptom perception, self-efficacy, and momentary factors that impact adherence behaviors.

Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial.

PURPOSE: The purpose of this study was to test our MUSTCOOL cooling patch intervention on the incidence of venous leg (VLU) and diabetic foot ulcer (DFU) recurrence over a previously healed wound. DESIGN: A 6-month randomized controlled trial. SUBJECTS AND SETTING: The target population was individuals with previously healed ulcers receiving care in outpatient wound centers in the Southeastern region of the United States. The sample comprised 140 individuals with recently healed ulcers; their average age was 62.4 years (SD = 12 years); 86 (61.4%) were male; and 47 (33.6%) were Black or African American. METHODS: Participants were randomized to the MUSTCOOL or placebo patch. Both groups received instructions to apply the patch 3 times per week, and engage in standard of care including compression and leg elevation (VLU) or therapeutic footwear and hygiene (DFU). Demographic data were collected at baseline, and incidence measures taken at 1, 3, and 6 months. We also studied whether new ulcers developed on the adjacent leg or foot. Data were reported in frequencies/percentages. RESULTS: One hundred seventeen participants (84%) were analyzed who completed 6 months of study participation. Thirteen percent (9/69) and 17% (12/69) developed a recurrent or new VLU, respectively; 29% (14/48) and 13% (6/48) developed a recurrent or new DFU, respectively. One person in the DFU group developed both a recurrent and new ulcer. For 9 recurrent VLUs, 6 (66.7%) recurred in the MUSTCOOL group and 3 (33.3%) receiving the placebo. Of the 15 recurrent DFUs (includes individual who developed both a recurrent and new ulcer), 10 (66.7%) recurred in the MUSTCOOL group and 5 (33.3%) receiving the placebo. CONCLUSIONS: While the incidence of ulcer recurrent was slightly higher in the MUSTCOOL group, this finding was not considered clinically relevant. Overall ulcer recurrence during the 6-month study period was lower than reports in the literature, the time frame in which recurrence rates are highest. TRIAL REGISTRATION: The study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156)-https://clinicaltrials.gov/ct2/show/NCT02626156.

Food Allergy Symptom Self-Management With Technology (FASST) mHealth Intervention to Address Psychosocial Outcomes in Caregivers of Children With Newly Diagnosed Food Allergy: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Approximately 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. OBJECTIVE: In 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. METHODS: This 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. RESULTS: Phase I study activities have been completed, and Phase II participant enrollment into the randomized controlled trial is expected to commence in 2021. CONCLUSIONS: With 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 REGISTRATION: ClinicalTrials.gov Identifier NCT04512924: https://clinicaltrials.gov/ct2/show/NCT04512924. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25805.

An observational study protocol to explore loneliness and systemic inflammation in an older adult population with chronic venous leg ulcers.

BACKGROUND: Chronic venous leg ulcers (CVLUs) are the most common type of lower extremity wound. Even when treated with evidenced-based care, 30-50% of CVLUs fail to heal. A specific gap exists about the association between psychosocial stressors, particularly loneliness, and biomarkers of inflammation and immunity. Loneliness is highly prevalent in persons with CVLUs, has damaging effects on health, and contributes to the development of multiple chronic conditions, promotes aberrant inflammation, and diminishes healing. However, the confluence of loneliness, inflammation and the wound healing trajectory has not been elucidated; specifically whether loneliness substantially mediates systemic inflammation and alters healing over time. This study seeks to address whether there is a specific biomarker profile associated with loneliness, CVLUs, and wound healing that is different from non-lonely persons with CVLUs. METHODS: An observational prospective study will identify, characterize and explore associations among psychosocial stressors, symptoms and biomarkers between 2 CVLU groups, with loneliness+ (n = 28) and without loneliness- (n = 28) during 4 weeks of wound treatment, measured at 3 time points. We will examine psychosocial stressors and symptoms using psychometrically-sound measures include PROMIS® and other questionnaires for loneliness, social isolation, depression, anxiety, stigma, sleep, fatigue, pain, quality of life, cognition, and function. Demographics data including health history, sex, age, wound type and size, wound age, and treatment will be recorded from the electronic health record. We will characterize a biomarker panel of inflammatory genes including chemotaxic and growth factors, vascular damage, and immune regulators that express in response to loneliness to loneliness and CVLUs using well-established RNA sequence and PCR methods for whole blood samples. In an exploratory aim we will explore whether age and sex/psychological stressors and symptoms indicate potential moderation/mediation of the effect of loneliness on the biomarker profile over the study period. DISCUSSION: This study will provide insight into the influence of psychosocial stressors, symptoms, and biological mechanisms on wound healing, towards advancing a future healing prediction model and interventions to address these stressors and symptoms experienced by persons with CVLUs.

A cluster randomized controlled trial to assess the efficacy of a telehealth-based train-the-trainer mealtime intervention delivered by respite care center volunteers to caregivers of persons with dementia to improve nutritional outcomes and quality of life.

BACKGROUND: Persons with dementia with mild to moderate cognitive impairment are at risk for developing impairments with activities of daily living such as the ability to feed oneself, that negatively influence health. Lack of caregiver skills related to mealtime planning for persons with dementia and the ability to cope with dysfunctional behaviors are well-documented factors that influence nutritional status outcomes, lead to weight loss, poor quality of life, and impact their ability to remain at home. METHODS: A cluster randomized controlled trial with a parallel mixed methods evaluation processes will be conducted to examine the efficacy of a train-the-trainer program using non-paid volunteers in respite care centers to deliver a telehealth mealtime intervention guided by the theory-based C3P Model-Change the Person, Change the People, Change the Place (C3P). In this six-month study, dyads of caregivers and persons with mild to moderate dementia receiving respite care services will be randomized to receive either the telehealth intervention or enhanced usual care. Within the intervention group, dyads will be partnered with a C3P trained volunteer who will work with caregivers via videoconference to devise and implement mealtime plans. Under usual care, dyads will receive standardized educational materials modified from The Savvy Caregiver Program for Alzheimer's disease. The primary outcomes include weight maintenance or gain of the person with dementia and quality of life of the caregiver. A multi-level evaluation process utilizing respite center administrators and directors, volunteers, and caregivers will explore intervention fidelity, acceptability and sustainability. Using both the CONSORT and SPIRIT checklists as guidance, the comprehensive study design is more fully described in this manuscript. DISCUSSION: In this trial, we will lay the groundwork to examine the efficacy and sustainability of a train-the-trainer telehealth program that could be widely disseminated by national Alzheimer's organizations and readily adopted by community agencies to provide additional resources to assist families in managing mealtimes at home, while promoting the quality of life of both the caregiver and the person with dementia. TRIAL REGISTRATION: This study was registered with clinicaltrials.gov: NCT03622814 on August 9, 2018..

A Lower Leg Physical Activity Intervention for Individuals With Chronic Venous Leg Ulcers: Randomized Controlled Trial.

BACKGROUND: Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions, are often physically deconditioned, and demonstrate high levels of physical inactivity. OBJECTIVE: The 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. METHODS: In 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. RESULTS: A 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. CONCLUSIONS: The 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 REGISTRATION: ClinicalTrials.gov NTC02632695; https://clinicaltrials.gov/ct2/show/NCT02632695.

FOOTFIT Physical Activity mHealth Intervention for Minimally Ambulatory Individuals With Venous Leg Ulcers: A Randomized Controlled Trial.

PURPOSE: The purpose of this study was to investigate the use of an mHealth application (app), self-management physical activity intervention FOOTFIT with an added patient-provider connectivity feature (FOOTFIT+), that was designed to strengthen the lower extremities of minimally ambulatory individuals with venous leg ulcers (VLUs). DESIGN: Randomized controlled trial. SUBJECTS AND SETTING: Twenty-four adults 18 years and older with VLUs being treated in 2 wound clinics in the Southeastern United States participated in this study. METHODS: Preliminary estimates and 95% confidence intervals for the medians of short-term functional impacts on foot function, strength, ankle range of motion, walking capacity, depression, and physical functioning were obtained pre- and postassessment after the 6-week intervention trial. RESULTS: There were negligible changes in either group for foot function. It is noted that both groups experienced substantial foot and ankle impairment at baseline. The greatest improvement in range of motion was noted in the FOOTFIT group for dorsiflexion of the right ankle (4.6 ± 5.22 lb/in over baseline) whereas strength decreased in both ankles for dorsiflexion and plantar flexion in the FOOTFIT+ group. No improvements were noted in walking distance or physical health for FOOTFIT (slight decrease -2.9 ± 5.6) and FOOTFIT+ (slight increase 3.0 ± 6.6) during the 6-week study period. CONCLUSIONS: In a minimally ambulatory population with VLUs, our mHealth FOOTFIT intervention composed of progressive exercise "boosts" demonstrated minimal short-term effects. We recommend engagement with the app for a longer period to determine longer-term outcomes of lower extremity function.

A Feasibility Study to Develop and Test a Cognitive Behavioral Stress Management Mobile Health Application for HIV-Related Fatigue.

CONTEXT: Exacerbated by life stressors, fatigue is the most common symptom for people living with HIV. OBJECTIVE: To adapt, develop, and assess the feasibility of a Cognitive Behavioral Stress Management Mobile Health (CBSM mHealth) application (app) for HIV-related fatigue. METHODS: This study had two phases: app development with key informants (N = 5) and a randomized controlled trial (N = 30). Patients randomized to the intervention group completed 10 weekly CBSM modules; those in the control group received a generic healthy lifestyle app. Measures included HIV-related fatigue, depression, anxiety, stressful life events, CD4 count, HIV viral load, credibility and acceptability of the intervention, and barriers to treatment participation. RESULTS: We were able to recruit participants for this study, and they were able to complete the required measures. They found the intervention to be credible and acceptable and reported few barriers to treatment participation. The direction of change in the primary outcome, a decrease in fatigue, is in the expected direction and provides evidence of the promise of the intervention, which still needs to be tested in an adequately powered trial. For completers (randomized to the intervention group and completed at least 80% of the modules), there were significant changes (95% CI; lower scores indicate improvement) in fatigue intensity (from 64.2 to 59.7) and overall fatigue-related functioning (from 6.6 to 4.2). CONCLUSION: We have proof of concept as to the feasibility, acceptability, and initial signals of efficacy for an mHealth intervention to help people with HIV-related fatigue better cope with stress and reduce their fatigue.

Managing Asthma and Obesity Related Symptoms (MATADORS): An mHealth Intervention to Facilitate Symptom Self-Management among Youth.

Youth with multi-morbidity (one or more chronic diseases) are at increased risk of further morbidity and early mortality as they enter their adult years. Recent increases in both asthma and obesity among youth have led to high health care utilization, increased health related complications, and expanded risks of subsequent cardiovascular disease burden. Common symptoms seen with asthma and obesity include fatigue, pain, depression, and anxiety. These symptoms can result in decreased physical activity, social isolation, and poor quality of life, which also may contribute to increased morbidity and mortality over time. Youth ages 10-17 are in a transitionary period where their overall health and disease management shifts from one of parental oversight to one where the youth gradually experience increased autonomy over their health and care management. Managing Asthma and Obesity Related Symptoms (MATADORS), is a mHealth technology-enhanced nurse-guided intervention that incorporates a novel mobile health application and motivational enhancement principles within a behavioral activation framework. Providing high-risk youth with strategies to enhance symptom self-management may result in decreased symptom prevalence, improved quality of life, and long-term reduction of cardiovascular morbidity and mortality as they move into adulthood. Moreover, developing low-cost, scalable tools with end-user input may facilitate promote early intervention and improved access to care, and reduce overall disease burden and healthcare costs.

Effectiveness of cooling therapy (cryotherapy) on leg pain and self-efficacy in patients with chronic venous disease: A randomized controlled trial.

BACKGROUND: Individuals with chronic venous disease (CVeD) frequently experience associated leg pain that may influence disease management self-efficacy. OBJECTIVE: To evaluate the influence of a cooling intervention on leg pain associated with more severe stages of CVeD and self-efficacy. This was a secondary aim of the trial. DESIGN: Randomized, blinded, comparator-controlled, multisite trial. SETTING: Three wound clinics and an academic medical research center in the United States of America. PARTICIPANTS: 276 participants (54.3% female, 46.7% male) with stage 4 and 5 CVeD were randomly assigned by computer generated tables to the cooling intervention group (n = 138) or control group (n = 138). INTERVENTIONS: Participants received either a cooling (intervention) leg cuff or placebo cuff (control) to apply topically over the affected skin area. Both groups performed standard of care including wearing compression wraps and elevating legs for 30 min during the intervention. Study visits occurred at baseline, and months 1, 3, 6, and 9. METHODS: Visit measures included: Numeric Rating Scale (NRS) for short term pain; VEINES-QOL/Sym questionnaire for long-term pain; and, the Self Efficacy for Managing Chronic Disease Scale (SEMCD-6) for self-efficacy. Data were collected from September 2010 to December 2015 and analyzed using pooled t-tests, Chi-square tests, and mixed effects models. Observed 9-month patient retention rates were 94/138 (68.1%) in the intervention group and 91/138 (65.9%) in the control group. The primary analysis was based on the intention-to-treat principle. RESULTS: Both the cooling intervention and control group experienced statistically significant decreases in unadjusted and adjusted mean NRS pain scores of 1.2 (95% CI: (-1.82, -0.64); p < 0.0001) and 1.8 (95% CI: (-2.31, -1.24); p < 0.0001) respectively from baseline, however, no statistically significant differences in change scores were observed between groups. The unadjusted mean VEINES-QOL/Sym pain scores had statistically significant decreases of 0.9 ((95% CI: (-1.07, -0.62) p < 0.0001 cooling)) and 0.8 (95% CI: (-1.09, -0.55) p < 0.0001 - control) points. When adjusting the scores for demographic and clinical features, both cooling and control groups maintained statistically significant decreases (p < 0.001 for both). No statistically significant differences in change scores were observed between groups. The unadjusted and adjusted mean self-efficacy scores had no statistically significant improvements from baseline to month 9 within and between the cooling and control groups. CONCLUSIONS: Pain was reduced in both groups while self-efficacy did not change. Findings suggest that strictly implemented standard of CVeD care in each study group, with or without cooling, improved pain while there were no effects on self-efficacy.

Symptoms Associated With Chronic Venous Disease in Response to a Cooling Treatment Compared to Placebo: A Randomized Clinical Trial.

PURPOSE: The purpose of this study was to examine the efficacy of a self-administered cooling treatment on clinically meaningful differences (CMDs) in symptom changes in patients with chronic venous disease. DESIGN: Blinded, prospective, randomized controlled trial. SUBJECTS AND SETTING: Two hundred seventy-six community-dwelling adults 21 years and older with skin changes and/or a healed venous leg ulcer (Clinical-Etiologic-Anatomic-Pathologic [CEAP] 4 and 5 classification) completed the 6-month active treatment period. METHODS: Participants were recruited from wound and medicine clinics and from the general population through referrals or advertisements. Participants were randomly allocated to a sham control cuff or interventional cooling cuff group. Demographic and symptom-specific data were collected at baseline and at months 1, 3, and 6 with the 11-item symptom Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptom (VEINES QOL/Sym) questionnaire subscale for heavy legs, aching legs, swelling, night cramps, heating or burning sensation, restless legs, throbbing, itching, tingling sensation (pins and needles), pain, and irritability. Participants in the intervention group received a cooling gel cuff and those in the control group received a cotton-filled cuff to be place around the most affected lower leg during leg elevation. Both groups received standard of care for their chronic venous disease with compression wraps and skin hygiene. Dosing consisted of daily 30-minute treatment for 1 month, twice weekly for 2 months, and then thrice weekly for 3 months. To analyze and compare data, a mixed percentage clinically meaningful percentage change was used to assess CMDs in symptoms between groups for treatment modality, sex, and age group. RESULTS: All symptoms showed improvement, with throbbing, aching, itching, and pain demonstrating the greatest CMD in response to the cooling treatment. For throbbing and aching, similar improvements were noted in response to cooling; 50% in the cooling group showed improvement, whereas 60% in both groups responded favorably to pain. More than 50% of females and males reported improvements in throbbing; both males and females reported 60% improvements in pain in response to cooling. In contrast, far fewer females reported worsening of aching in the treatment group as compared to male participants (8% vs 20%). Age differences were noted for throbbing in the younger group (<65 years of age); older individuals 65 years or older saw CMDs in aching in response to cooling. CONCLUSIONS: Of the 11 symptoms, aching, throbbing, itching, and pain had greater clinically meaningful improvements in response to a cooling cuff applied to lower leg skin affected by chronic venous disease. These CMDs inform evidence-based practice by enhancing clinician understanding of which symptoms, physical, physiological, and behavioral outcomes, respond to treatment change in a meaningful way for the patient.

Does cryotherapy improve skin circulation compared with compression and elevation in preventing venous leg ulcers?

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.