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
Results First Posted : February 12, 2020
Last Update Posted : February 12, 2020
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|
|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|
Experimental: SPIN-SSLED Program
13-session 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.
- Participant Feedback on Usability of Program Materials [ Time Frame: 13 week ]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
- Participant Feedback on Ease of Use of the Go-To Videoconferencing Program [ Time Frame: 13 weeks ]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.
- Participant Feedback on Ease of Use of the Online Forum [ Time Frame: 13 weeks ]Participant Interviews. Participants were asked to report the overall technological difficulties that they experienced using the online forum.
- Personnel Requirements [ Time Frame: 13 weeks ]Time logs completed by research staff will be used to assess personnel requirements for the full-scale trial.
- Duration of Management of Online Training Group Participation [ Time Frame: 13 weeks ]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.
- Percentage of Topics Adequately Covered in the Sessions [ 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. Two raters reviewed 54 topics from 7 randomly chosen modules from both training groups to examine if the contents were adequately covered.
- Number of Participants That Reported no Technological Problems [ Time Frame: 13 weeks ]Log of technological problems reported by staff and participants will be maintained and reported descriptively.
- 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.
- Personal Health Questionnaire (PHQ-8) [ Time Frame: baseline and 13 weeks ]The Personal Health Questionnaire (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). The total values range from 0 to 24, with higher scores indicating higher levels of depressive symptoms. The difference of pre- and post-trial means was calculated.
- Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0 [ Time Frame: baseline and 13 weeks ]The Patient Reported Outcomes Measurement Information System (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. Total raw scores are obtained by summing item scores for each domain, which are converted into T-scores standardized from the general US population (mean=50, SD=10). High scores represent more of the domain being measured. Thus, on symptom-oriented domains, higher scores represent worse symptomatology. On the function-oriented domains, higher scores represent better functioning.The difference of pre- and post-trial means was calculated.
- Oldenburg Burnout Inventory (OLBI) [ Time Frame: baseline and 13 weeks ]The Oldenburg Burnout Inventory (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). The total values range from 16 to 64, with higher score representing higher level of exhaustion and disengagement. The difference between pre- and post-trial means was calculated.
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
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3S 1Y9|
|Principal Investigator:||Brett Thombs, PhD||Jewish General Hospital and McGill Universit|