TY - JOUR
T1 - Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program
AU - on behalf of the SPIN Investigators
AU - Kwakkenbos, Linda
AU - Østbø, Nora
AU - Carrier, Marie Eve
AU - Nielson, Warren R.
AU - Fedoruk, Claire
AU - Levis, Brooke
AU - Henry, Richard S.
AU - Pope, Janet
AU - Frech, Tracy
AU - Gholizadeh, Shadi
AU - Johnson, Sindhu R.
AU - Piotrowski, Pamela
AU - Jewett, Lisa R.
AU - Gordon, Jessica
AU - Chung, Lorinda
AU - Bilsker, Dan
AU - Tao, Lydia
AU - Turner, Kimberly A.
AU - Cumin, Julie
AU - Welling, Joep
AU - Fortuné, Catherine
AU - Leite, Catarina
AU - Gottesman, Karen
AU - Sauvé, Maureen
AU - Reyna, Tatiana Sofia Rodriguez
AU - Hudson, Marie
AU - Larche, Maggie
AU - van Breda, Ward
AU - Suarez-Almazor, Maria E.
AU - Bartlett, Susan J.
AU - Malcarne, Vanessa L.
AU - Mayes, Maureen D.
AU - Boutron, Isabelle
AU - Mouthon, Luc
AU - Benedetti, Andrea
AU - Thombs, Brett D.
AU - Hummers, Laura K.
AU - Riggs, Robert
AU - Assassi, Shervin
AU - El-Baalbaki, Ghassan
AU - Ells, Carolyn
AU - Fligelstone, Kim
AU - Gietzen, Amy
AU - Guillot, Geneviève
AU - Harel, Daphna
AU - Hinchcliff, Monique
AU - Nguyen, Christelle
AU - Rannou, François
AU - Nielsen, Karen
AU - Richard, Michelle
N1 - 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).
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Cohort multiple RCT
KW - Feasibility trial
KW - Internet intervention
KW - Scleroderma
KW - Self-management
KW - Systemic sclerosis
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U2 - 10.1186/s40814-022-00994-5
DO - 10.1186/s40814-022-00994-5
M3 - Article
AN - SCOPUS:85125569729
VL - 8
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
SN - 2055-5784
IS - 1
M1 - 45
ER -