Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial.

BACKGROUND: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. Functional impairment of hands is common. The Scleroderma Patient-centered Intervention Network (SPIN)-HAND trial compared effects of offering access to an online self-guided hand exercise program to usual care on hand function (primary) and functional health outcomes (secondary) in people with SSc with at least mild hand function limitations. METHODS: The pragmatic, two-arm, parallel-group cohort multiple randomized controlled trial was embedded in the SPIN Cohort. Cohort participants with Cochin Hand Function Scale (CHFS) scores ≥ 3 and who indicated interest in using the SPIN-HAND Program were randomized (3:2 ratio) to an offer of program access or to usual care (targeted N = 586). The SPIN-HAND program consists of 4 modules that address (1) thumb flexibility and strength; (2) finger bending; (3) finger extension; and (4) wrist flexibility and strength. The primary outcome analysis compared CHFS scores 3 months post-randomization between participants offered versus not offered the program. Secondary outcomes were CHFS scores 6 months post-randomization and functional health outcomes (Patient-Reported Outcomes Measurement Information System profile version 2.0 domain scores) 3 and 6 months post-randomization. RESULTS: In total, 466 participants were randomized to intervention offer (N = 280) or usual care (N = 186). Of 280 participants offered the intervention, 170 (61%) consented to access the program. Of these, 117 (69%) viewed at least one hand exercise instruction video and 77 (45%) logged into the program website at least 3 times. In intent-to-treat analyses, CHFS scores were 1.2 points lower (95% CI - 2.8 to 0.3) for intervention compared to usual care 3 months post-randomization and 0.1 points lower (95% CI - 1.8 to 1.6 points) 6 months post-randomization. There were no statistically significant differences in other outcomes. CONCLUSION: The offer to use the SPIN-HAND Program did not improve hand function. Low offer uptake, program access, and minimal usage among those who accessed the program limited our ability to determine if using the program would improve function. To improve engagement, the program could be tested in a group format or as a resource to support care provided by a physical or occupational therapist. TRIAL REGISTRATION: NCT03419208 . Registered on February 1, 2018.

Intensity of care and perceived burden among informal caregivers to persons with chronic medical conditions: a systematic review and meta-analysis.

PURPOSE: Informal caregivers provide ongoing assistance to a loved one with a health condition. No studies have compared caregiving intensity and perception of burden across chronic medical conditions. MATERIALS AND METHODS: Databases were searched from inception through 11 September 2020 to identify studies that included the Level of Care Index or the Zarit Burden Inventory (ZBI) among caregivers for people with chronic diseases. Pooled mean ZBI scores and 95% confidence intervals by medical condition were calculated using a random effects model and heterogeneity with I2. RESULTS: Ninety-seven included articles reported on 98 unique samples across 21 chronic diseases. No study used the Level of Care Index. Among 12 disease groups with more than one study, heterogeneity was too high (I2 range: 0-99.6%, ≥76.5% in 11 groups) to confidently estimate burden. The percent of studies rated high risk of bias ranged from 0% to 98%, but all external validity items were rated as high-risk in >50% of studies. CONCLUSIONS: Findings highlight the need for studies on caregiver burden to improve sampling techniques; better report sampling procedures and caregiver and care recipient characteristics; and develop a standard set of outcomes, including a measure of caregiving intensity. Systematic Review Registration: CRD42017080962IMPLICATIONS FOR REHABILITATIONThe amount of burden reported by caregivers to loved ones is associated with reduced physical and mental health.We found considerable heterogeneity in perceived burden reported by informal caregivers across different studies within disease groups, which is likely related to methodological issues, including sampling techniques.Health care providers who use research on caregiver burden should assess how representative study samples may be and exercise caution in drawing conclusions.

Balance of group sizes in randomized controlled trials published in American Psychological Association journals.

OBJECTIVE: We evaluated whether sample size differences between arms of two-arm parallel group randomized controlled trials (RCTs) published in American Psychological Association (APA)-affiliated journals were consistently smaller than expected by chance with simple randomization. METHOD: We searched PsycINFO for two-arm parallel group RCTs in APA-affiliated journals published January 2007 to September 2017 that used individual randomization (1:1 allocation ratio), reported the number of participants randomized, and did not describe employing restrictive randomization (e.g., blocking). We queried authors because randomization processes were often not described in articles, and we conducted a post hoc logistic regression analysis to attempt to identify factors associated with overly balanced groups. RESULTS: We identified 203 eligible trials, but after the author query, it was determined that only 115 used simple randomization. Among those 115 trials, there was a significantly greater number of trials with smaller sample size differences between trial arms than would be expected by chance (p < .001); 89 of 115 (77%) had differences in trial arm sample sizes smaller than the 50% prediction interval threshold for these differences. Greater proportionate imbalance may be associated with larger trial size (odds ratio of 0.27, 95% CI [0.08, 0.94] for N > 200 vs. N ≤ 100); greater balance may be more common in higher impact journals, though this was not statistically significant. CONCLUSIONS: Education is needed to ensure that randomization procedures are implemented as intended and fully and accurately reported and that balanced group sample sizes are not understood as an indicator of trial quality. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Perceived Benefits and Facilitators and Barriers to Providing Psychosocial Interventions for Informal Caregivers of People with Rare Diseases: A Scoping Review.

BACKGROUND: Little is known about the benefits, and barriers and facilitators to providing psychosocial support to caregivers to a loved one with a rare disease. OBJECTIVE: The aim of our scoping review was to map evidence on (1) perceived benefits and (2) barriers and facilitators of establishing and maintaining services. METHODS: The CINAHL and PubMed databases were searched in December 2018. Qualitative and quantitative studies in any language that described perceived or tested benefits of participating in psychosocial interventions for caregivers, or the barriers and facilitators of providing these interventions, were eligible. RESULTS: Thirty-four studies were included. Interventions were behavioural or psychological, supportive, educational, or multicomponent. All included studies reported on the benefits of participating in psychosocial interventions; 14 (41%) studies also reported on facilitators and 19 (56%) reported on barriers. Benefits that were most commonly found included statistically significant improvements in emotional states (e.g. stress) and caregiver burden and narrative reports of intervention helpfulness. Statistically significant improvements in mental health outcomes (e.g. depression symptoms) were rarely detected. Four themes for facilitators were identified, including intervention characteristics, intervention delivery characteristics, provision of necessary resources, and support provided outside of the intervention. Four barrier themes were also identified: misalignment of intervention to caregiver needs, inability to make time for intervention, practical barriers, emotional barriers. CONCLUSIONS: Psychosocial interventions for caregivers to a loved one with a rare disease may be helpful in reducing stress, burden, and feelings of isolation among caregivers. Future research should design interventions for caregivers that take into account facilitators and barriers to establishing and maintaining such interventions.

Challenges and support service preferences of informal caregivers of people with systemic sclerosis: a cross-sectional survey.

Purpose: To evaluate the importance of different challenges experienced by informal caregivers to persons with systemic sclerosis (SSc) and identify priorities for support services that could be developed.Materials and Methods: Caregivers of people with SSc from three continents completed an online questionnaire to rate the importance of possible caregiver challenges and likelihood of using different forms of support services. Importance of challenges and likelihood of using support services were rated from 1 (not important; not likely to use) to 4 (very important; very likely to use).Results: Two hundred and two informal caregivers completed the survey (79 women, 123 men). Mean age was 58 years (standard deviation = 13). The most important challenges were related to supporting the care recipient with emotional difficulties and physical discomfort. Caregivers indicated that they would be more likely to use support services that involved online or hard-copy information resources, including those provided soon after diagnosis, compared to support that involved interacting with others.Conclusions: Supporting the care recipient in managing emotional difficulties and physical discomfort were important challenges among caregivers. Interventions delivered through hardcopy or online resources, including those delivered soon after the care recipient's diagnosis, were rated as being most likely to be used by caregivers.Implications for rehabilitationMany caregivers for individuals with systemic sclerosis report struggling to support their care recipient with emotional difficulties and physical discomfort.Rehabilitation professionals can aid in the development of support services that caregivers have identified as being likely to use and can refer caregivers to resources that they have identified as being helpful, such as educational information about the disease.The development of support services should focus on aspects of caring that caregivers found most challenging and be delivered in a format that considers caregiver preferences.

Factors associated with symptoms of depression among informal caregivers of people with systemic sclerosis: a cross-sectional study.

Purpose: Our study aimed to identify caregiver characteristics (gender, age, occupational status, educational attainment, relation to care recipient), care recipient characteristics (age, disease subtype), and caregiving factors (hours of care, perceived caregiving burden) associated with symptoms of depression among informal caregivers of persons with systemic sclerosis (also known scleroderma).as Materials and methods: A questionnaire was developed and administered online from December 2016 to June 2017 to informal caregivers of people with scleroderma, including the Patient Health Questionnaire-9 to assess depressive symptoms. Multiple linear regression was used to identify factors associated with depressive symptoms.Results: Caregivers (n = 202) were 60.9% male. Average age was 57.2 years (standard deviation = 14.4 years). Most caregivers were partners (72.3%), children (11.9%), or parents (7.4%), of care recipients. Self-reported caregiving burden (standardized regression coefficient [Formula: see text] = 0.54, p < 0.001) and hours of care per week ([Formula: see text] = 0.17, p = 0.005) were significantly associated with greater symptoms of depression.Conclusions: Depressive symptoms were primarily associated with caregiving burden among a sample of scleroderma caregivers. There is need to develop interventions targeting caregivers in scleroderma. Rehabilitation professionals should consider the specific needs of scleroderma caregivers and should provide or refer to support services as appropriate.Implications for RehabilitationMost people diagnosed with scleroderma are cared for by an informal caregiver and the majority of these caregivers experience mild symptoms of depression.For caregivers that experience moderate to severe symptoms of depression, the ability to provide care to a loved one with scleroderma may be more difficult.Rehabilitation professionals should be aware of the burden faced by caregivers of persons with scleroderma and provide support services or referrals as appropriate.

Protocol for a partially nested randomized controlled trial to evaluate the effectiveness of the Scleroderma Patient-centered Intervention Network Support Group Leader EDucation (SPIN-SSLED) Program.

BACKGROUND: Some people with rare diseases rely on peer-led support groups for disease-specific education and emotional and practical support. Systemic sclerosis (SSc), or scleroderma, is a rare autoimmune connective tissue disease. Many people with SSc cannot access support groups, and, when support groups exist, they may not be sustained due to challenges that could be addressed via leader training. The Scleroderma Patient-centered Intervention Network (SPIN), along with SSc patient organization partners, developed a training program for SSc patient support group leaders, the Scleroderma Support group Leader EDucation (SPIN-SSLED) Program. We recently completed a feasibility trial in which we successfully delivered the program to two groups of support group leaders who reported a high level of satisfaction with the program and its delivery. The primary objective of the full-scale SPIN-SSLED trial is to evaluate the effect of the program on support group leaders' self-efficacy for carrying out their leadership role. Secondary objectives include evaluating effects on leader burnout, leader satisfaction (participation efficacy), and emotional distress. METHODS/DESIGN: The SPIN-SSLED trial is a pragmatic randomized controlled trial (RCT) in which 180 support group leaders will be randomly allocated to training groups of 6 participants each or to a waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups, but not in the waitlist control. Participants allocated to the training program will receive the 13-module SPIN-SSLED Program, delivered via webinar over the course of 3 months in weekly 60-90-min sessions. The primary outcome is leader self-efficacy, measured by the Scleroderma Support Group Leader Self-efficacy Scale post-intervention. Secondary outcomes are leader self-efficacy at 3 months post-intervention, and leader burnout, volunteer job satisfaction (participation efficacy), and emotional distress post-intervention and at 3 months post-intervention. DISCUSSION: The SPIN-SSLED trial will test whether a training program for SSc patient support group leaders increases the self-efficacy of group leaders to carry out leadership tasks. The program has the potential to significantly improve the effectiveness and sustainability of existing SSc support groups, to increase the number of available support groups, and to be adapted for other chronic diseases. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03965780. Registered on 29 May 2019.

Skin Acute Wound Healing: A Comprehensive Review.

Experimental work of the last two decades has revealed the general steps of the wound healing process. This complex network has been organized in three sequential and overlapping steps. The first step of the inflammatory phase is an immediate response to injury; primary sensory neurons sense injury and send danger signals to the brain, to stop bleeding and start inflammation. The following target of the inflammatory phase, led by the peripheral blood mononuclear cells, is to eliminate the pathogens and clean the wound. Once this is completed, the inflammatory phase is resolved and homeostasis is restored. The aim of the proliferative phase, the second phase, is to repair wound damage and begin tissue remodeling. Fibroplasia, reepithelialization, angiogenesis, and peripheral nerve repair are the central actions of this phase. Lastly, the objective of the final phase is to complete tissue remodeling and restore skin integrity. This review provides present day information regarding the status of the participant cells, extracellular matrix, cytokines, chemokines, and growth factors, as well as their interactions with the microenvironment during the wound healing process.

Use of the nominal group technique to identify stakeholder priorities and inform survey development: an example with informal caregivers of people with scleroderma.

OBJECTIVES: The nominal group technique (NGT) allows stakeholders to directly generate items for needs assessment surveys. The objective was to demonstrate the use of NGT discussions to develop survey items on (1) challenges experienced by informal caregivers of people living with systemic sclerosis (SSc) and (2) preferences for support services. DESIGN: Three NGT groups were conducted. In each group, participants generated lists of challenges and preferred formats for support services. Participants shared items, and a master list was compiled, then reviewed by participants to remove or merge overlapping items. Once a final list of items was generated, participants independently rated challenges on a scale from 1 (not at all important) to 10 (extremely important) and support services on a scale from 1 (not at all likely to use) to 10 (very likely to use). Lists generated in the NGT discussions were subsequently reviewed and integrated into a single list by research team members. SETTING: SSc patient conferences held in the USA and Canada. PARTICIPANTS: Informal caregivers who previously or currently were providing care for a family member or friend with SSc. RESULTS: A total of six men and seven women participated in the NGT discussions. Mean age was 59.8 years (SD=12.6). Participants provided care for a partner (n=8), parent (n=1), child (n=2) or friend (n=2). A list of 61 unique challenges was generated with challenges related to gaps in information, resources and support needs identified most frequently. A list of 18 unique support services was generated; most involved online or in-person delivery of emotional support and educational material about SSc. CONCLUSIONS: The NGT was an efficient method for obtaining survey items directly from SSc caregivers on important challenges and preferences for support services.