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The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial
NA trial testing SPIN-SSLED Program in Scleroderma in 10 participants. Completed in 10 August 2018.
| Lead sponsor | Lady Davis Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 10 |
| Start date | 18 April 2018 |
| Primary completion | 10 August 2018 |
| Estimated completion | 10 August 2018 |
| Sites | 1 location across Canada |
Lady Davis Institute
18 and older, any sex, with Scleroderma or Systemic Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 10 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 8 |
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 2 |
Participant Interviews. Participants were asked to report the overall technological difficulties that they experienced using the online forum.
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 10 | |
| SPIN-SSLED Program | 0 |
Time logs completed by research staff will be used to assess personnel requirements for the full-scale trial.
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 96 |
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 4 |
Log of technological problems reported by staff and participants will be maintained and reported descriptively.
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 8 |
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 1.7 | 0.67 – 2.72 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 0.38 | -0.50 – 1.27 |
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 wor
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 0.45 | -0.42 – 1.36 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SPIN-SSLED Program | 0.44 | -0.44 – 1.33 |
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?
3 peer-reviewed publications reference this trial (live from Europe PMC):
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