Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program

Pilot and Feasibility Studies

Shadi Gholizadeh¹  Brooke Levis²  Linda Kwakkenbos³  Maria E. Suarez-Almazor⁴  Maureen D. Mayes⁵  Tracy Frech⁶  Jessica Gordon⁷  Susan J. Bartlett⁸  Andrea Benedetti⁹  Maggie Larche^1,10  Lorinda Chung^1,11  Janet Pope^1,12  Lisa R. Jewett^1,13  Vanessa L. Malcarne^1,14  Ward van Breda^1,15  Dan Bilsker^1,16  Tatiana Sofia Rodriguez Reyna^1,17  Kimberly A. Turner^1,18  Marie-Eve Carrier^1,18  Claire Fedoruk^1,18  Nora Østbø^1,18  Lydia Tao^1,18  Julie Cumin^1,18  Marie Hudson^1,19  Richard S. Henry^2,20  Brett D. Thombs^2,21  Joep Welling^2,22  Catherine Fortuné^2,23  Pamela Piotrowski^2,24  Maureen Sauvé^2,25  Karen Gottesman^2,26  Luc Mouthon^2,27  Warren R. Nielson^2,28  Sindhu R. Johnson^2,29  Catarina Leite^3,30  Isabelle Boutron^3,31 

[1] California School of Professional Psychology/Alliant, Los Angeles, CA, USA;Centre for Prognosis Research, School of Medicine, Keele University, Staffordshire, UK;Department of Clinical Psychology, Radboud University, Montessorilaan 3, 6525, Nijmegen, HR, The Netherlands;Department of General Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA;Department of Internal Medicine, University of Texas McGovern School of Medicine, Houston, TX, USA;Department of Internal Medicine, University of Utah, Salt Lake City, UT, USA;Department of Medicine, Hospital for Special Surgery, New York City, NY, USA;Department of Medicine, McGill University, Montreal, Quebec, Canada;Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada;Department of Medicine, McGill University, Montreal, Quebec, Canada;Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada;Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada;Department of Medicine, McMaster University and St Joseph’s Healthcare, Hamilton, Ontario, Canada;Department of Medicine, Stanford University, Palo Alto, CA, USA;Department of Medicine Palo Alto VA Health Care System, Palo Alto, CA, USA;Department of Medicine, University of Western Ontario, London, Ontario, Canada;Department of Psychology, Institute of Community and Family Psychiatry, Jewish General Hospital, Montreal, Quebec, Canada;Department of Psychology, San Diego State University, San Diego, CA, USA;Joint Doctoral Program in Clinical Psychology, San Diego State University/University of California San Diego, San Diego, CA, USA;Faculty of Behavioural and Movement Sciences, Vrije University, Amsterdam, The Netherlands;Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada;Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada;Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, Mexico;Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada;Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada;Department of Medicine, McGill University, Montreal, Quebec, Canada;Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada;Department of Psychiatry, McGill University, Montreal, Quebec, Canada;Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada;Department of Psychiatry, McGill University, Montreal, Quebec, Canada;Department of Medicine, McGill University, Montreal, Quebec, Canada;Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada;Department of Psychology, McGill University, Montreal, Quebec, Canada;Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada;Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada;NVLE Dutch patient organization for Systemic Autoimmune Diseases, Utrecht, The Netherlands;Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada;Private practice – Nutrition, Hamilton, Ontario, Canada;Scleroderma Canada, Hamilton, Ontario, Canada;Scleroderma Society of Ontario, Hamilton, Ontario, Canada;Scleroderma Foundation, Los Angeles, CA, USA;Service de Médecine Interne, Centre de Référence Maladies Autoimmunes Systémiques Rares d’Ile de France, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France;APHP-CUP, Hôpital Cochin, Université de Paris, F-75014, Paris, France;St. Joseph’s Health Care, London, Ontario, Canada;Toronto Scleroderma Program, Mount Sinai Hospital & Toronto Western Hospital, Toronto, Ontario, Canada;Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada;University of Minho, Braga, Portugal;Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), Inserm, INRA, Paris, France;Centre d’Épidémiologie Clinique, Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Paris, France;

关键词: Feasibility trial;    Scleroderma;    Systemic sclerosis;    Self-management;    Internet intervention;    Cohort multiple RCT;   

DOI  :  10.1186/s40814-022-00994-5

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsThis 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.ResultsOf 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).ConclusionsThe 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 registrationclinicaltrials.gov, NCT03914781. Registered 16 April 2019.

【 授权许可】

CC BY