The SPIN – Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED)

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Brief Title

The SPIN - Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED)

Official Title

The Scleroderma Patient-centered Intervention Network - Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED)

Brief Summary

      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.
    

Detailed Description

      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).
    


Study Type

Interventional


Primary Outcome

Leader Self-Efficacy: Scleroderma Support Group Leader Self-efficacy Scale (SSGLSS)

Secondary Outcome

 Leader Self-Efficacy: Scleroderma Support Group Leader Self-efficacy Scale (SSGLSS)

Condition

Scleroderma, Systemic

Intervention

SPIN-SSLED Program

Study Arms / Comparison Groups

 Training group
Description:  Participants in the training group will receive a 13-week training program delivered via videoconference. The program includes 13 modules delivered via videoconference over the course of the 3-month program in weekly 60- to 90-minute sessions. Participants will receive a training manual, be shown filmed vignettes, and will have access to a chatroom and an online resource centre.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

180

Start Date

September 23, 2019

Completion Date

July 2021

Primary Completion Date

July 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Be a current scleroderma support group leader or have been identified by our partner
             patient organizations as a new leader

          -  Be available to participate at times when sessions are scheduled

          -  Be able to use the internet to access the training program

          -  Be English or French-speaking

        Exclusion Criteria:

          -  Having a co-leader enrolled in trial
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Brett D Thombs, PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03965780

Organization ID

17-112A


Responsible Party

Principal Investigator

Study Sponsor

Lady Davis Institute


Study Sponsor

Brett D Thombs, PhD, Principal Investigator, Lady Davis Institute for Medical Research, McGill University


Verification Date

May 2021