Abstract
Background: The Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program. Methods: This feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged. Results: Of 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program’s modules (median = 2). Conclusions: The results of this study will lead to substantial changes for the planned full-scale RCT of the SPIN-SELF Program that we will incorporate into a planned additional feasibility trial with progression to a full-scale trial. These changes include transitioning to a conventional RCT design with pre-randomization consent and supplementing the online self-help with peer-facilitated videoconference-based groups to enhance engagement. Trial registration: clinicaltrials.gov, NCT03914781. Registered 16 April 2019.
| Original language | English |
|---|---|
| Article number | 45 |
| Pages (from-to) | 1-15 |
| Number of pages | 15 |
| Journal | Pilot and Feasibility Studies |
| Volume | 8 |
| Issue number | 1 |
| Early online date | 27 Feb 2022 |
| DOIs | |
| Publication status | Published - Dec 2022 |
Bibliographical note
Funding Information:Funding for the SPIN-SELF Feasibility Trial was provided by the Canadian Institutes of Health Research (TR3-119192; PJT-148504). In addition, SPIN has received funding for its core activities, including the SPIN Cohort, from the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada, the Jewish General Hospital Foundation, Montreal, Canada, McGill University, Montreal, Canada, the Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, the Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland. Dr. Levis was supported by a Fonds de recherche du Québec - Santé Postdoctoral Training Fellowship. Dr. Johnson is supported by the Gurmej Kaur Dhanda Scleroderma Research Award, and then Scleroderma Association of British Columbia. Dr. Thombs was supported by a Tier 1 Canada Research Chair. Funders of the SPIN-SELF feasibility trial had no role in the study design, and/or writing and publishing decisions.
Publisher Copyright:
© 2022, The Author(s).
Funding
Funding for the SPIN-SELF Feasibility Trial was provided by the Canadian Institutes of Health Research (TR3-119192; PJT-148504). In addition, SPIN has received funding for its core activities, including the SPIN Cohort, from the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada, the Jewish General Hospital Foundation, Montreal, Canada, McGill University, Montreal, Canada, the Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, the Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland. Dr. Levis was supported by a Fonds de recherche du Québec - Santé Postdoctoral Training Fellowship. Dr. Johnson is supported by the Gurmej Kaur Dhanda Scleroderma Research Award, and then Scleroderma Association of British Columbia. Dr. Thombs was supported by a Tier 1 Canada Research Chair. Funders of the SPIN-SELF feasibility trial had no role in the study design, and/or writing and publishing decisions.
| Funders | Funder number |
|---|---|
| Fonds de recherche du Québec - Santé Postdoctoral Training Fellowship | |
| Gurmej Kaur Dhanda Scleroderma | |
| Scleroderma Association of British Columbia | |
| Tier 1 Canada Research Chair | |
| Canadian Institutes of Health Research | TR3-119192, PJT-148504 |
| Canadian Institutes of Health Research | |
| Canadian HIV Trials Network, Canadian Institutes of Health Research |
Keywords
- Cohort multiple RCT
- Feasibility trial
- Internet intervention
- Scleroderma
- Self-management
- Systemic sclerosis