Phenotypic Clusters and Multimorbidity in Hypermobile Ehlers-Danlos Syndrome.

Objective: To perform a retrospective clinical study in order to investigate phenotypic penetrance within a large registry of patients with hypermobile Ehlers-Danlos syndrome (hEDS) to enhance diagnostic and treatment guidelines by understanding associated comorbidities and improving accuracy in diagnosis. Patients and Methods: From May 1, 2021 to July 31, 2023, 2149 clinically diagnosed patients with hEDS completed a self-reported survey focusing on diagnostic and comorbid conditions prevalence. K-means clustering was applied to analyze survey responses, which were then compared across gender groups to identify variations and gain clinical insights. Results: Analysis of clinical manifestations in this cross-sectional cohort revealed insights into multimorbidity patterns across organ systems, identifying 3 distinct patient groups. Differences among these phenotypic clusters provided insights into diversity within the population with hEDS and indicated that Beighton scores are unreliable for multimorbidity phenotyping. Conclusion: Clinical data on the phenotypic presentation and prevalence of comorbidities in patients with hEDS have historically been limited. This study provides comprehensive data sets on phenotypic presentation and comorbidity prevalence in patients with hEDS, highlighting factors often overlooked in diagnosis. The identification of distinct patient groups emphasizes variations in hEDS manifestations beyond current guidelines and emphasizes the necessity of comprehensive multidisciplinary care for those with hEDS.

The relationship between uncertainty in illness and psychological adjustment to chronic illness.

Using Mishel's Uncertainty in illness theory, this integrative review sought to identify how uncertainty in illness and psychological adjustment to illness are associated with chronic illness to guide development of interventions to support psychological adjustment. A search was conducted via EBSCOHost to answer the question "What is the relationship between uncertainty in illness and psychological adjustment to chronic illness?" Two key factors were identified as having an impact on psychological adjustment to chronic illness in the presence of uncertainty in illness including uncertainty appraisal and the type of coping strategies used in response to the appraisal. Individuals with a chronic illness diagnosis are more likely to experience increased levels of uncertainty in illness and decreased psychological adjustment to illness. A better understanding of these two concepts is important to augment and or guide the development of interventions to support psychological adjustment.

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).

The Management of Pediatric Asthma Using Telehealth: An Integrative Review.

Introduction: Asthma is one of the most chronic noncommunicable diseases of childhood, affecting 1 in 12 children in the United States. The use of telemedicine for the management of pediatric asthma has shown improved health outcomes; however, it is important to understand what can impact its acceptance. The purpose of this review was to identify the facilitators and barriers to pediatric asthma management, as viewed by stakeholders. Methods: An electronic literature search was performed using PubMed, Scopus, and Cumulative Index to Nursing and Allied Health Literature Complete. Articles included in the review contained perceptions of the use of telemedicine for the management of pediatric asthma, as viewed by stakeholders. The socioecological model was used as the theoretical framework to extract data based on its five levels. Results: After reviewing full texts of 143 articles, 118 were excluded, leaving 25 articles included in this review. A majority of included articles focused on mobile health (m-Health) studies for the management of pediatric asthma, with the remaining articles studying synchronous telemedicine or a combination of modalities. Common themes were identified; however, most were focused on the use of m-Health and few studies contained the viewpoints of the caregiver, children, or providers regarding synchronous telemedicine. Discussion: This integrative review identified a number of facilitators and barriers for the management of asthma using telemedicine. However, more qualitative studies are needed to evaluate the perceptions of caregivers, patients, and primary providers regarding synchronous telehealth. It was also recognized that telemedicine may increase instead of reduce health care disparities.

Preliminary Findings of an Adapted Nurse-Led Palliative Care Intervention.

Context: Despite the increased number of people living with Alzheimer's disease and related dementias (PLWD), limited early palliative care interventions exist for this population. Adapting promising interventions for other progressive disease conditions may address this need. Few published studies have examined this topic using recognized adaptation frameworks. Objectives: To systematically adapt a nurse-led palliative care intervention for people with idiopathic pulmonary fibrosis and caregivers (A Program of SUPPORT™) for PLWD and caregivers before pilot/feasibility testing. Methods: The Step Framework guided the transformation of A Program of SUPPORT™ to A Program of SUPPORT-D™ (dementia). The Step Framework was modified to include key stakeholder feedback on the initial intervention adaptation using a qualitative approach with semistructured interviews conducted with 5 community support professionals (respite care leaders and staff) and 10 caregivers from the Southeastern United States. A prioritization matrix was created to analyze qualitative feedback and inform intervention refinements. Data were collected between November 2021 and March 2022. Results: The modified Step Framework was a feasible guide for intervention adaptation. Three main themes emerged: organization, terminology, and content. Eight subthemes were identified within the content theme: strategies for providing care, planning ahead, understanding the illness, resources, safety, symptom management, social support, and self-management. Moreover, all participants provided largely positive feedback for the initial adaptation including over 200 suggestions for revision. Majority of participants suggested revising existing adapted content rather than including additional new content. The prioritization matrix was very useful in guiding additional intervention refinements, incorporating suggestions deemed highly important and improving the clarity of SUPPORT-D™. Conclusion: Adapting existing interventions for use by PLWD and caregivers is a practical approach that can increase the speed of translation of applicable and effective interventions used in other populations. Early feedback, prioritized using a matrix, helped further refine the initial adaptation.

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.

Disparities in Cancer Screening in Sexual and Gender Minority Populations: A Secondary Analysis of Behavioral Risk Factor Surveillance System Data.

OBJECTIVES: To describe cancer screening characteristics and better understand individual-, environmental-, and organizational-level barriers of sexual and gender minority (SGM) populations. . SAMPLE & SETTING: This study was conducted using a combined sample from the Behavioral Risk Factor Surveillance System (BRFSS) national dataset from 2014 and 2016. METHODS & VARIABLES: Chi-square tests for independence and logistic regression analysis tests were performed to determine whether relationships existed between SGM status and demographics. RESULTS: Black respondents or those who reported their race as other, were female, had some college or technical school or more, and had healthcare coverage were less likely to present for cancer screening. SGM respondents who were in good or better health; were unmarried; were aged 18-44 years or 45-55 years; or were Asian, Native American, or Hawaiian, or reported their race as other, had higher odds of screening for cancer. IMPLICATIONS FOR NURSING: Disparities in cancer screening among SGM populations are not well documented. These findings will inform structured education and preventative interventions to improve screening participation among SGM populations.

Piloting an automated clinical trial eligibility surveillance and provider alert system based on artificial intelligence and standard data models.

BACKGROUND: To advance new therapies into clinical care, clinical trials must recruit enough participants. Yet, many trials fail to do so, leading to delays, early trial termination, and wasted resources. Under-enrolling trials make it impossible to draw conclusions about the efficacy of new therapies. An oft-cited reason for insufficient enrollment is lack of study team and provider awareness about patient eligibility. Automating clinical trial eligibility surveillance and study team and provider notification could offer a solution. METHODS: To address this need for an automated solution, we conducted an observational pilot study of our TAES (TriAl Eligibility Surveillance) system. We tested the hypothesis that an automated system based on natural language processing and machine learning algorithms could detect patients eligible for specific clinical trials by linking the information extracted from trial descriptions to the corresponding clinical information in the electronic health record (EHR). To evaluate the TAES information extraction and matching prototype (i.e., TAES prototype), we selected five open cardiovascular and cancer trials at the Medical University of South Carolina and created a new reference standard of 21,974 clinical text notes from a random selection of 400 patients (including at least 100 enrolled in the selected trials), with a small subset of 20 notes annotated in detail. We also developed a simple web interface for a new database that stores all trial eligibility criteria, corresponding clinical information, and trial-patient match characteristics using the Observational Medical Outcomes Partnership (OMOP) common data model. Finally, we investigated options for integrating an automated clinical trial eligibility system into the EHR and for notifying health care providers promptly of potential patient eligibility without interrupting their clinical workflow. RESULTS: Although the rapidly implemented TAES prototype achieved only moderate accuracy (recall up to 0.778; precision up to 1.000), it enabled us to assess options for integrating an automated system successfully into the clinical workflow at a healthcare system. CONCLUSIONS: Once optimized, the TAES system could exponentially enhance identification of patients potentially eligible for clinical trials, while simultaneously decreasing the burden on research teams of manual EHR review. Through timely notifications, it could also raise physician awareness of patient eligibility for clinical trials.

Addressing Physical, Functional, and Physiological Outcomes in Older Adults using an Integrated mHealth Intervention "Active for Life": A Pilot Randomized Controlled Trial.

Objective: We evaluated components of an integrated, mobile health-based intervention "Activate for Life" (AFL) on health outcomes in lower-income older adults (≥ 60 years). Methods: AFL incorporates balance (Otago; OG), physical strength (Gentle Yoga and yogic Breathing; GYYB), and mental engagement (Behavioral Activation; BA) components. Thirty participants were randomly allocated to one of three study arms (n=10): OG (Arm 1), OG+GYYB (Arm 2), or OG+GYYB+BA (Arm 3; a.k.a. "full AFL"). Participants were evaluated for physical, functional, and physiological endpoints at baseline and post-intervention (12-weeks and/or 3-month follow up). Results: Improvements in pain interference and 1,5- anhydroglucitol biomarker levels over time were noted for all arms. No significant changes were observed for other physical, functional, or physiological measures. Discussion: This study illustrates potential benefits of the AFL intervention on the health of lower-income older adults. Lessons learned from this pilot trial will inform design improvements for a large-scale randomized controlled trial.

2021 Guideline for Management of Patients With Lower-Extremity Wounds Due to Diabetes Mellitus and/or Neuropathic Disease: An Executive Summary.

This article provides an executive summary of the Wound, Ostomy, and Continence Nurses Society's (WOCN) "2021 Guideline for Management of Patients With Lower-Extremity wounds Due to Diabetes Mellitus and/or Neuropathic Disease." This executive summary presents an overview of the systematic process used to update and develop the guideline and recommendations from the guideline for screening and diagnosis, assessment, and management and education of patients with lower-extremity wounds due to diabetes mellitus and/or neuropathic disease. In addition, the executive summary provides suggestions for implementing recommendations from the guideline. The guideline is a resource for WOC nurse specialists and other nurses and health care professionals who work with adults who have/or are at risk for lower-extremity wounds due to diabetes mellitus/neuropathic disease. The complete guideline includes the evidence and references supporting the recommendations, and it is available in print and electronically from the Wound, Ostomy, and Continence Nurses Society, 1120 Rt 73, Suite 200, Mount Laurel, New Jersey, 08054; Web site: www.wocn.org.

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 .

Systems-Level Factors Affecting Registered Nurses During Care of Women in Labor Experiencing Clinical Deterioration.

BACKGROUND: Maternal morbidity and mortality are at their highest recorded levels in the United States, with more than 50% of maternal deaths deemed preventable. Women in labor often experience gradual morbidity, but signs of worsening condition may not be noticed by clinicians. Nurses are well-positioned to notice these signs, but performance obstacles inhibit nurses' work. There is scant literature describing the obstetric work system. This study sought to identify the systems-level factors affecting registered nurses during care of women in labor experiencing clinical deterioration. METHODS: A convergent parallel mixed methods design combining survey data from the adapted Performance Obstacles for ICU Nurses instrument and semistructured interviews with registered nurses, certified nurse midwives, and physicians was used. Data were collected on the labor and delivery floor of a tertiary care center in Boston from July 2021 through August 2021. Interviews were coded using Bradley's integrated deductive and inductive methods and the Systems Engineering Initiative for Patient Safety (SEIPS) categories. RESULTS: Data included 46 surveys and 16 interviews. Identified performance obstacles were in the categories of tasks, tools and technology, and physical environment. Emergent themes included swamped, feeling inadequate, and is this safe? CONCLUSION: Issues with task overload, tools, and technology inhibit nurses' abilities to respond appropriately to women in labor who experience clinical deterioration. Emergent themes imply a relationship between task overload and burnout. Health care administrators should improve staffing, decrease nurse task load, and include bedside nurses in the redesign of tools and technology to mitigate the harms of performance obstacles.

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.

Trial-level factors affecting accrual and completion of oncology clinical trials: A systematic review.

BACKGROUND: Cancer is the second-leading cause of death in the United States. Clinical trials translate basic science discoveries into treatments needed by cancer patients. Inadequate accrual of trial participants is one of the most significant barriers to the completion of oncology clinical trials. OBJECTIVE: The purpose of this study was to investigate trial-level factors that affect accrual and/or completion of oncology clinical trials, identify gaps in the literature, and indicate opportunities for future research. DESIGN: A systematic review of the literature on trial-level factors that affect accrual and/or completion of oncology clinical trials was performed. Searches in PubMed and Scopus identified 6582 studies. Based on eligibility criteria, 16 studies were selected for the review. Results were analyzed according to the following: a) background factors, b) disease-related, c) treatment-related, and d) trial design. RESULTS: Background factors that were investigated in relation to oncology clinical trial accrual and/or completion included sponsor, number and location of participating institutions, competing trials, time of trial opening, and fast-track status. Disease-related factors included the annual incidence and type(s) of targeted cancer. Several types of treatment such as drugs, radiation and surgery were examined in the studies. Trial design factors included trial development time, eligibility criteria, randomization, sample size, trial phase, placebo use, and required protocol procedures and their timing. CONCLUSION: With low patient participation rates in oncology clinical trials that hold promise for future treatments, it is imperative that trial-level factors affecting accrual be identified and addressed to facilitate the completion of trials.

Prevention of Failure to Rescue in Obstetric Patients: A Realist Review.

BACKGROUND: At least 40% of maternal deaths are attributable to failure to rescue (FTR) events. Nurses are positioned to prevent FTR events, but there is minimal understanding of systems-level factors affecting obstetric nurses when patients require rescue. AIMS: To identify the nurse-specific contexts, mechanisms, and outcomes underlying obstetric FTR and the interventions designed to prevent these events. METHODS: A realist review was conducted to meet the aims. This review included literature from 1999 to 2020 to understand the systems-level factors affecting obstetric nurses during FTR events using a human factors framework designed by the Systems Engineering Initiative for Patient Safety. RESULTS: Existing interventions addressed the prevention of maternal death through education of clinicians, improved protocols for care and maternal transfer, and an emphasis on communication and teamwork. LINKING EVIDENCE TO ACTION: Few researchers addressed task overload or connected employee and organizational outcomes with patient outcomes, and the physical environment was minimally considered. Future research is needed to understand how systems-level factors affect nurses during FTR events.

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.

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.