Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program.
Обработка статьи · этапы, ошибки и управление
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История · было → стало
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Kwakkenbos Linda, Østbø Nora, Carrier Marie-Eve, Nielson Warren R, Fedoruk Claire, Levis Brooke, Henry Richard S, Pope Janet, Frech Tracy, Gholizadeh Shadi, Johnson Sindhu R, Piotrowski Pamela, Jewett Lisa R, Gordon Jessica, Chung Lorinda, Bilsker Dan, Tao Lydia, Turner Kimberly A, Cumin Julie, Welling Joep, Fortuné Catherine, Leite Catarina, Gottesman Karen, Sauvé Maureen, Reyna Tatiana Sofia Rodriguez, Hudson Marie, Larche Maggie, van Breda Ward, Suarez-Almazor Maria E, Bartlett Susan J, Malcarne Vanessa L, Mayes Maureen D, Boutron Isabelle, Mouthon Luc, Benedetti Andrea, Thombs Brett D, SPIN Investigators
Аннотация
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.