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

Abstract

BackgroundSome 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/designThe 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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03965780. Registered on 29 May 2019.

Effects of a multi-faceted education and support programme on anxiety symptoms among people with systemic sclerosis and anxiety during COVID-19 (SPIN-CHAT): a two-arm parallel, partially nested, randomised, controlled trial

“…Groups were facilitated by people with systemic sclerosis (n=8; one facilitated two groups) or patient organisation staff members (n=2) who had previously completed SPIN's support group facilitator training programme. 16 Facilitators supported participants to integrate coping skills into daily routines and led group support segments. An experienced master's level social worker provided supervision.…”

The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

“…Many of the trial management procedures to be used in the SPIN-SELF trial have been successfully tested in previous SPIN trials with common design and intervention delivery features, including the SPIN Scleroderma Support Group Leader Education Program (SPIN-SSLED) Trial [ 35 , 36 ], SPIN COVID-19 Home-isolation Activities Together Program (SPIN-CHAT) Trial [ 26 , 27 ], SPIN Hand Function Program (SPIN-HAND) Trial [ 25 ], and initial SPIN-SELF Feasibility Trial [ 20 ] and including procedures for recruitment, enrollment, randomization, and delivery of an online intervention, which do not need additional feasibility verification. Thus, as shown in Table 1 , we have identified only 3 stoppage criteria.…”

“…Each videoconference-based intervention group will be led by a person with SSc who previously received training as a support group leader via our SPIN-SSLED Program [ 35 , 36 ]. Group facilitators will support participants to develop self-management skills and integrate educational material from the online toolkit into their daily routines and will moderate group discussions.…”

“…Group sessions will be delivered using the GoToMeeting® videoconferencing platform, which we have used successfully in previous trials [ 27 , 35 , 36 ]. Email and phone support will be available to intervention participants to resolve any problems with the program website or with group session logins.…”

Effects of non-pharmacological and non-surgical interventions on health outcomes in systemic sclerosis: protocol for a living systematic review

“…Published RCTs include an evaluation of a personalised physical therapy programme (N=220), 16 an internet-based selfmanagement programme (N=247), 17 a home-based exercise programme (N=44) 18 and a comparison of two educational interventions in the rehabilitation of microstomia (N=63), 19 for example. RCTs in progress with results expected in the next year include a web-based hand rehabilitation programme (N=466), 20 a supportgroup leader educational programme (N targeted=180), 21 and a COVID-19 related mental health intervention (N targeted=162). 22 The proposed living systematic review aims to identify and evaluate RCT evidence on the effectiveness of non-pharmacological and non-surgical interventions on health outcomes, including quality of life outcomes, and on the delivery of services in SSc.…”