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

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ClinicalTrials.gov Identifier: NCT03508661
Recruitment Status : Completed
First Posted : April 26, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Brett D Thombs, Lady Davis Institute

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?


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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Scleroderma Patient-centered Intervention Network (SPIN) - Scleroderma Support Group Leader EDucation (SSLED) Program Feasibility Trial
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : August 10, 2018
Actual Study Completion Date : August 10, 2018


Arm Intervention/treatment
Experimental: SPIN-SSLED Program Other: SPIN-SSLED Program
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.




Primary Outcome Measures :
  1. Participant feedback on usability of program materials [ Time Frame: 13 weeks ]
    Participant interviews

  2. Participant feedback on ease of use of the GoTo videoconferencing program [ Time Frame: 13 weeks ]
    Participant interviews

  3. Participant feedback on ease of use of the online forum [ Time Frame: 13 weeks ]
    Participant interviews

  4. Personnel requirements [ Time Frame: 13 weeks ]
    Time logs completed by research staff will be used to assess personnel requirements for the full-scale trial

  5. Challenges for study personnel [ Time Frame: 13 weeks ]
    Trainer interviews on challenges in training format, group management, and logistical aspects of the program

  6. Fidelity to program manual [ Time Frame: 13 weeks ]
    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

  7. Technological performance of the GoTo videoconferencing platform [ Time Frame: 13 weeks ]
    Log of technological problems reported by staff and participants


Secondary Outcome Measures :
  1. The Scleroderma Support Group Leader Self-efficacy Scale (SSGLSS) [ Time Frame: 13 weeks ]
    The SSGLSS consists of 32 core items that assess the confidence of SSc support group leaders to carry out tasks necessary for leading a support group successfully. Items are scored on a 6-point scale ranging from Strongly Disagree to Strongly Agree (scored 0-5). Possible total scores range from 0 to 160 with higher scores indicating greater self-efficacy.

  2. Personal Health Questionnaire (PHQ-8) [ Time Frame: 13 weeks ]
    The PHQ-8 is a self-administered 8-item scale to assess depression that has been validated for use in populations with SSc. Items are rated on a 4-point Likert scale (not at all, several days, more than half the days, nearly every day) with higher scores indicating higher levels of depressive symptoms.

  3. Patient Reported Outcomes Measurement Information System (PROMIS-29) profile version 2.0 [ Time Frame: 13 weeks ]
    The PROMIS-29 measure contains 29 items, which include four items each for domains reflecting physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to perform social roles, plus a single item on pain intensity. Higher scores represent more of the domain being measured.

  4. Oldenburg Burnout Inventory (OLBI). [ Time Frame: 13 weeks ]
    The OLBI is a 16-item measure of burnout that assesses levels of exhaustion and disengagement in work populations. Items were adapted and reviewed by project investigators for use within the support group leader population. Items are scored on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT03508661


Locations
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Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3S 1Y9
Sponsors and Collaborators
Lady Davis Institute

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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: NCT03508661     History of Changes
Other Study ID Numbers: 17-112
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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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
Support group
Training
Feasibility

Additional relevant MeSH terms:
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Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Pathologic Processes
Connective Tissue Diseases
Skin Diseases