The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial

NCT03508661 | Completed Results

• 1 other identifier: 17-112
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Many people living with a rare disease turn to peer-led support groups to cope with their condition and access educational resources. Systemic sclerosis (SSc), or scleroderma, is a rare autoimmune connective tissue disease where peer-led support groups play an important role. There are currently approximately 200 SSc support groups in Canada and the US, most of which are led by people with SSc. Many SSc patients, however, cannot access support groups. In other cases, support groups are not sustained due to factors that include the burden on group leaders living with a serious, unpredictable disease and limited group leadership skills of some untrained leaders. Our partners from Scleroderma Canada and the Scleroderma Foundation in the US are committed to improving support group accessibility and effectiveness. These organizations maintain a list of active support groups, but currently do not provide training or other resources to groups or their leaders. To address this gap, our team, including investigators and patients from the Scleroderma Patient-centered Intervention Network (SPIN), developed the Scleroderma Support group Leader EDucation (SPIN-SSLED) Program, which is designed to improve support group leader confidence and self-efficacy, reduce burnout, improve emotional well-being, and improve health-related quality of life. In the planned full-scale randomized controlled trial (RCT) that will follow our feasibility trial, we will evaluate whether the SPIN-SSLED Program is effective in improving SSc support group leaders' self-efficacy for carrying out their leader role (primary) and if it reduces burnout, improves emotional well-being, and improves health-related quality of life (secondary). Thus, the SPIN-SSLED Feasibility Trial answers the following research questions: (1) Is a full-scale SPIN-SSLED RCT feasible? (2) Are adaptations needed to the research design for the planned full-scale RCT? (3) Are there ways to improve the SPIN-SSLED Program for delivery in the planned full-scale RCT based on input of support group leaders who participate in the feasibility trial?

Conditions

Scleroderma; Systemic Sclerosis

Keywords

Scleroderma; Systemic Sclerosis; Support group; Training; Feasibility

Outcome Measures

Primary Outcomes (7)

• Participant Feedback on Usability of Program Materials

  Participant Interviews. Participants were asked if they found the program to be useful. The number of participants who found the program materials to be useful were recorded

  13 week

• Participant Feedback on Ease of Use of the Go-To Videoconferencing Program

  Participant Interviews. Participants were asked if they encountered difficulties during the use of Go-To videoconferencing program. Number of participants who found no difficulty in using the program is reported.

  13 weeks

• Participant Feedback on Ease of Use of the Online Forum

  Participant Interviews. Participants were asked to report the overall technological difficulties that they experienced using the online forum.

  13 weeks

• Personnel Requirements

  Time logs completed by research staff will be used to assess personnel requirements for the full-scale trial.

  13 weeks

• Duration of Management of Online Training Group Participation

  The challenges related to the management of online training group participation encountered by study personnel, including assisting participants with accessing GoToMeeting and managing Qualtrics for data collection. Time required for management of training groups could not be assigned to individual participants as sometimes the group needed support, and other times an individual did. Thus, the number presented represents the total time required.

  13 weeks

• Percentage of Topics Adequately Covered in the Sessions

  Intervention fidelity will be evaluated through the observation of entire sessions for a randomly selected sample of 25% of video-recorded sessions. Raters will evaluate adherence to each session's goals and content using a checklist coding system based on a standardized format. Two raters reviewed 54 topics from 7 randomly chosen modules from both training groups to examine if the contents were adequately covered.

  13 weeks

• Number of Participants That Reported no Technological Problems

  Log of technological problems reported by staff and participants will be maintained and reported descriptively.

  13 weeks

Secondary Outcomes (4)

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

  13 weeks

• Personal Health Questionnaire (PHQ-8)

  baseline and 13 weeks

• Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0

  baseline and 13 weeks

• Oldenburg Burnout Inventory (OLBI)

  baseline and 13 weeks

Study Arms (1)

SPIN-SSLED Program

EXPERIMENTAL

13-session SPIN-SSLED Program

Other: SPIN-SSLED Program

Interventions

SPIN-SSLED Program OTHER

The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (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 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.

SPIN-SSLED Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a current SSc support group leader or have been identified by Scleroderma Canada or the Scleroderma Foundation as a new leader who will initiate a new support group
• Be available to participate at times when sessions are scheduled
• Be English-speaking

You may not qualify if:

• Unable to use the internet to access and participate in training sessions or to complete study questionnaires online

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3S 1Y9, Canada

Location

Related Publications (1)

• Thombs BD, Dyas L, Pepin M, Aguila K, Carrier ME, Tao L, Harb S, Malcarne VL, El-Baalbaki G, Pelaez S, Sauve M, Hudson M, Platt RW; SPIN-SSLED Patient Advisory Team. Scleroderma Patient-centered Intervention Network-Scleroderma Support group Leader EDucation (SPIN-SSLED) program: non-randomised feasibility trial. BMJ Open. 2019 Nov 11;9(11):e029935. doi: 10.1136/bmjopen-2019-029935.

  PMID: 31719073 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Brett Thombs
• Organization: Lady Davis Institute

brett.thombs@mcgill.ca

514-340-8222

Study Officials

• Brett Thombs, PhD

  Jewish General Hospital and McGill Universit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• 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: April 15, 2018
• First Posted: April 26, 2018
• Study Start: April 18, 2018
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: February 12, 2020
• Results First Posted: February 12, 2020

Record last verified: 2020-02

Locations

CA (1)