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

NCT03965780 | Completed

• 1 other identifier: 17-112A
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma, Systemic

Keywords

Scleroderma; Systemic Sclerosis; Peer Support Group; Training

Outcome Measures

Primary Outcomes (1)

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

  Leader self-efficacy will be evaluated using the Scleroderma Support Group Leader Self-efficacy Scale (SSGLSS) which was developed by the SPIN research team, including the members of the SPIN Support Group Advisory Team, to measure support group leader self-efficacy for performing leader tasks. The SSGLSS is a 32-item scale is scored on a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree) with possible total scores from 32 to 192 and higher scores indicating greater self-efficacy. The primary outcome analysis will compare SSGLSS scores between the intervention and waitlist control groups using a generalized linear random effects model, adjusted for baseline SSGLSS scores.

  3-months post-randomization

Secondary Outcomes (5)

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

  6-months post-randomization

• Burnout

  3-months post-randomization and 6-months post-randomization

• Leader Satisfaction with Leading a Support Group

  3-months post-randomization and 6-months post-randomization

• Emotional Distress

  3-months post-randomization and 6-months post-randomization

• Participant Satisfaction: SPIN-SSLED Program

  3-months post-randomization

Study Arms (2)

Training group

EXPERIMENTAL

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.

Other: SPIN-SSLED Program

Wait-list control group

NO INTERVENTION

Participants in the wait-list control group will not receive the training program and will have no access to the resources indicated above.

Interventions

SPIN-SSLED Program OTHER

The SPIN-SSLED Program is a 3-month-long (13 sessions) group training program designed to be delivered via videoconferencing to provide information and skills to improve leader support group leaders' confidence and self-efficacy to carry out their leadership roles and reduce the burden on them of leading a support group. Each session is about 90 minutes long and covers one of the 13 modules of the program. Module topics includes: (1) The Leader's Role; (2) Starting a Support Group; (3) Structuring a Support Group Meeting; (4) Scleroderma 101; (5) Successful Support Group Culture; (6) Managing Support Group Dynamics; (7) Loss and Grief: The support group leader; (8) Loss and Grief in Scleroderma: Supporting group members; (9) Advertising and Recruitment for the Support Group; (10) The Continuity of the Group; (11) Supporting Yourself as a Leader; (12) Remote Support Groups; and (13) Transitions in Support Groups.

Also known as: Scleroderma Patient-centered Intervention Network - Scleroderma Support group Leader EDucation (SPIN-SSLED) Program

Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Having a co-leader enrolled in trial

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3S 1Y9, Canada

Location

Related Publications (3)

• Thombs BD, Aguila K, Dyas L, Carrier ME, Fedoruk C, Horwood L, Canedo-Ayala M, Sauve M, Kwakkenbos L, Malcarne VL, El-Baalbaki G, Pelaez S, Connolly K, Hudson M, Platt RW; SPIN-SSLED Support Group Advisory Team. 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. Trials. 2019 Dec 12;20(1):717. doi: 10.1186/s13063-019-3747-z.

  PMID: 31831073 BACKGROUND

• Thombs BD, Levis B, Carrier ME, Dyas L, Konrad V, Sauve M, Benedetti A; SPIN-SSLED Support Group Advisory Team. Association of support group leader experience with Scleroderma Patient-centered Intervention Network Support group Leader EDucation Program outcomes: Secondary analysis of a two-arm parallel partially nested randomized controlled trial. J Scleroderma Relat Disord. 2024 Sep 4:23971983241272742. doi: 10.1177/23971983241272742. Online ahead of print.

  PMID: 39552943 DERIVED

• Thombs BD, Levis B, Carrier ME, Dyas L, Nordlund J, Tao L, Aguila K, Bourgeault A, Konrad V, Sauve M, Connolly K, Henry RS, Ostbo N, Levis AW, Kwakkenbos L, Malcarne VL, El-Baalbaki G, Hudson M, Wurz A, Culos-Reed SN, Platt RW, Benedetti A; SPIN-SSLED Support Group Leader Advisory Team. Effects of a support group leader education program jointly developed by health professionals and patients on peer leader self-efficacy among leaders of scleroderma support groups: a two-arm parallel partially nested randomised controlled trial. Orphanet J Rare Dis. 2022 Oct 28;17(1):396. doi: 10.1186/s13023-022-02552-x.

  PMID: 36307891 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Brett D Thombs, PhD

  Lady Davis Institute for Medical Research, McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty of Medicine, McGill University; Senior Investigator, Lady Davis Institute for Medical Research, Jewish General Hospital

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: September 23, 2019
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after the collection of the primary outcome
• Access Criteria: Approval of proposed purpose for data access

Locations

CA (1)