Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965780
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Brett D Thombs, Lady Davis Institute

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.


Condition or disease Intervention/treatment Phase
Scleroderma, Systemic Other: SPIN-SSLED Program Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Scleroderma Patient-centered Intervention Network - Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED)
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: Training group
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

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.

Other Name: Scleroderma Patient-centered Intervention Network - Scleroderma Support group Leader EDucation (SPIN-SSLED) Program

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



Primary Outcome Measures :
  1. Leader Self-Efficacy: Scleroderma Support Group Leader Self-efficacy Scale (SSGLSS) [ Time Frame: 3-months post-randomization ]
    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.


Secondary Outcome Measures :
  1. Leader Self-Efficacy: Scleroderma Support Group Leader Self-efficacy Scale (SSGLSS) [ Time Frame: 6-months post-randomization ]
    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.

  2. Burnout [ Time Frame: 3-months post-randomization and 6-months post-randomization ]
    Leader burnout will be measured by the Oldenburg Burnout Inventory (OLBI), which assesses exhaustion and disengagement due to burnout and has been validated in diverse populations (16 items, 4-point scale from 1 = strongly disagree to 4 = strongly agree). The OLBI was initially designed for work-related burnout but has been adapted for numerous settings and in multiple countries and languages. The SPIN research team revised the wording of each OLBI item to reflect the support group environment rather than a work environment (e.g., "I find my work to be a positive challenge" was revised to "I find my role as a support group leader to be a positive challenge"). The OLBI has a two-factor structure (exhaustion and disengagement) with good measurement properties. Higher scores indicate higher levels of exhaustion and disengagement. Internal consistency reliability (Cronbach's alpha) in patients with SSc was 0.84 for exhaustion and 0.80 for disengagement.

  3. Leader Satisfaction with Leading a Support Group [ Time Frame: 3-months post-randomization and 6-months post-randomization ]
    Leader satisfaction with leading a support group will be measured using a modified version of the participation efficacy subscale of the Volunteer Satisfaction Index (VSI). The original version of the VSI was validated using a sample of volunteers (N = 327) and was found to be reliable and constructually valid. As several other studies have done previously, we have modified the wording of some of the items to reflect participants' volunteer role as support group leaders. The participation efficacy subscale asks respondents to indicate their level of satisfaction on 7 items using a 7-point Likert scale from 1 (very dissatisfied) to 7 (very satisfied).

  4. Emotional Distress [ Time Frame: 3-months post-randomization and 6-months post-randomization ]
    Emotional distress will be evaluated using the Patient Health Questionnaire-8 (PHQ-8) items which measure depressive symptoms over the last 2 weeks on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day). Higher scores indicate more depressive symptoms. The PHQ-8 performs equivalently to the PHQ-9, which has been shown to be a valid measure of depressive symptoms in patients with scleroderma.

  5. Participant Satisfaction: SPIN-SSLED Program [ Time Frame: 3-months post-randomization ]
    Participant satisfaction with the SPIN-SSLED Program will be evaluated with the Client Satisfaction Questionnaire-8 (CSQ-8), a standardized survey that is used to assess satisfaction with health services. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with total scores ranging from 8 to 32 and higher scores indicating greater satisfaction with the program. This measure will only be administered to participants in the intervention arm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965780


Contacts
Layout table for location contacts
Contact: Lydia Tao, MEd 514-340-8222 ext 26813 lydia.xi.tao@gmail.com
Contact: Marie-Eve Carrier, MSc 514-340-8222 ext 23238 carrier.marie.eve@gmail.com

Locations
Layout table for location information
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3S 1Y9
Contact: Brett Thombs, PhD    5143408222 ext 25112    brett.thombs@mcgill.ca   
Contact: Marie-Eve Carrier, MSc    5143408222 ext 26812    carrier.marie.eve@gmail.com   
Sponsors and Collaborators
Lady Davis Institute
Investigators
Layout table for investigator information
Principal Investigator: Brett D Thombs, PhD Lady Davis Institute for Medical Research, McGill University

Layout table for additonal information
Responsible Party: Brett D Thombs, Professor, Faculty of Medicine, McGill University; Senior Investigator, Lady Davis Institute for Medical Research, Jewish General Hospital, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT03965780     History of Changes
Other Study ID Numbers: 17-112A
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 12 months after the collection of the primary outcome
Access Criteria: Approval of proposed purpose for data access

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brett D Thombs, Lady Davis Institute:
Scleroderma
Systemic Sclerosis
Peer Support Group
Training
Additional relevant MeSH terms:
Layout table for MeSH terms
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases