The Scleroderma Patient-centered Intervention Network - Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED)
The Scleroderma Patient-centered Intervention Network - Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED)
Many people living with scleroderma, a rare autoimmune connective tissue disease, attend support groups to help them cope with the disease. Support groups provide a safe environment where people facing a similar challenge can come together to share disease-related experiences and exchange practical and emotional support. This is especially important for rare diseases such as scleroderma as organized support services can be limited.
However, many people with scleroderma do not have access to scleroderma support groups, and many support groups that are initiated are not sustained due to a number of obstacles. Leaders of these support groups play a particularly important role. They are responsible for a wide range of tasks including administrative details that go into planning meetings, facilitating effective and meaningful discussions, managing any issues that may arise in group dynamics, balancing their own needs with the needs of the group and many more.
The Scleroderma Patient-centered Intervention Network (SPIN) team has worked with patient organizations and an advisory team of scleroderma support group leaders to develop the Support group Leader EDucation (SPIN-SSLED) Program for scleroderma support group leaders with the goals of (1) providing information and resources to leaders to help them feel more comfortable, confident and supported in their roles and (2) to provide people with the skills they need to establish scleroderma support groups where none exist.
The SPIN-SSLED Trial will be used to evaluate the effectiveness of the SPIN-SSLED Program on scleroderma support group leaders' self-efficacy (primary outcome) in carrying out their leader tasks (which is defined as their perceived ability to carry out actions needed to be successful in support group leadership), burnout and emotional well-being.
People with rare diseases face the same challenges as those with more common diseases plus unique challenges, including limited disease education and lack of specialized support options. Professionally organized support services for common diseases are often available through the healthcare system, but are not typically available in rare diseases. As a result, many people with rare diseases look to peer-led support groups for disease-specific education and support.
Support groups provide important benefits to people with burdensome medical conditions, based on the principle that people who face similar challenges can empower one another through emotional and practical support. Support groups may be held face-to-face or online, led by professionals or peers, and have a structured or an unstructured format. Activities typically involve an educational or information-sharing component and the exchange of emotional and practical support.
Systemic sclerosis (SSc), or scleroderma, is a rare, chronic, autoimmune connective tissue disease characterized by abnormal fibrotic processes and excessive collagen production. Peer-led support groups play an important role for many people with SSc. Currently, there are approximately over 250 leaders and co-leaders affiliated with SPIN-SSLED's partners Scleroderma Canada and Canadian provincial organizations, including Sclérodermie Québec, the Scleroderma Foundation (United States), Scleroderma & Raynaud's UK (United Kingdom), Scleroderma Australia and Australian state organizations, and Scleroderma New Zealand, almost all led by people with SSc. Many people with SSc, however, cannot access support groups, and many initiated support groups are not sustained due to challenges that could be addressed via leader training. SPIN partner organizations are committed to improving support group quality and access by providing training to existing support group leaders and to new leaders to start groups in underserved areas and via the Internet.
The SPIN-SSLED Program was developed by a team of researchers with expertise in SSc, patient organization representatives, and a Patient Advisory Board comprised of current SSc support group leaders. The program content and design are based on results of SPIN's preliminary research on support groups in SSc and informed by instructional material for support group leaders SPIN identified via the internet and by consultations with support group leaders. The program uses a problem-based learning approach. Problem-based learning is a learner-centered approach that integrates theory and practice by providing the necessary knowledge and skills, presenting a complex, real-world problem, then working to identify an approach to solving the problem. To implement this, each module, or learning session, will introduce a topic and provide an overview of key information. Then, there will be a guided discussion among training group participants about possible approaches and solutions. The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. In addition to the live modules, SPIN-SSLED participants will receive a workbook that summarizes didactic material that is provided and will be shown filmed vignettes demonstrating effective group facilitation techniques and ways to respond to support group issues. SPIN-SSLED participants will also have access to an online resource center that includes a range of helpful tools for leaders including files of SSc related videos to show at meetings and an online forum for leaders to post questions, open only to leaders enrolled in the training program.
The aim of the SPIN-SSLED Trial is to assess the effectiveness of the SPIN-SSLED Program on scleroderma support group leaders' self-efficacy (primary outcome), which SPIN defined as their perceived ability to carry out actions needed to be successful in support group leadership, burnout and emotional well-being. Additionally, participants will be asked about their satisfaction with the program.
SPIN's partners from the Scleroderma Canada, including Sclérodermie Québec, Scleroderma Foundation, Scleroderma & Raynaud's UK, Scleroderma Association of New South Wales and Scleroderma New Zealand will contact group leaders to describe the SPIN-SSLED Full-Scale Trial and ascertain interest in participating. They will also provide SPIN-SSLED personnel with a list of their support group leaders. SPIN-SSLED personnel will then send email invitations with the consent form to all support group leaders on these lists. Following this, support group leaders will be contacted by phone within 24 hours to describe the study, review the consent form, and answer questions any question they may have. SPIN will enroll 180 SSc support group leaders to participate in the trial. 90 participants will be randomized to the waitlist control group and 90 to the training group. Three groups will run simultaneously per 3-month period for a total of 15 months.
Based on SPIN's previous experience with videoconferencing and consistent with previous trials of videoconference training, to maximize effective interaction and participation, 6 group leaders will be assigned to each training group. Training sessions will be delivered using the GoToMeeting® videoconferencing platform, a high-performance platform that has been used successfully for similar applications.
A survey will be administered to all participants before the trial. Participants randomized to either the training group or waitlist control group will also be administered a baseline, post-intervention and 3-months post-intervention surveys for outcome measures. The first survey will contain a demographics questionnaire designed for this study that includes basic demographic information, such as gender, age and employment status and disease-related variables, such as years since scleroderma diagnosis as well as their general availabilities to attend the 60-90 minute sessions. All questionnaires will be completed using the online surveying tool Qualtrics. Once the online survey data is collected, data will be exported to the statistics software program, International Business Machines Corporation Statistical Package for the Social Sciences (IBM SPSS).
Inclusion Criteria:
Exclusion Criteria: