Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)

PeerJ

article

Linda Kwakkenbos¹  Marie-Eve Carrier²  Joep Welling³  Kimberly A. Turner²  Julie Cumin²  Mia Pépin²  Cornelia van den Ende⁴  Anne A. Schouffoer⁵  Marie Hudson²  Ward van Breda⁸  Maureen Sauve⁹  Maureen D. Mayes^1,11  Vanessa L. Malcarne^1,12  Warren R. Nielson^1,13  Christelle Nguyen^1,14  Isabelle Boutron^1,15  François Rannou^1,14  Brett D. Thombs²  Luc Mouthon^2,22 

[1] Radboud University Nijmegen;Lady Davis Institute of the Jewish General Hospital;NVLE Dutch patient organization for systemic autoimmune diseases;Sint Maartenskliniek;Leiden University Medical Center;Haga Teaching Hospital;Department of Medicine, McGill University;Faculty of Behavioural and Movement Sciences, Vrije Universiteit;Scleroderma Society of Ontario;Scleroderma Canada;University of Texas McGovern School of Medicine;San Diego State University;St. Joseph’s Health Care;Université de Paris;Centre d’Épidémiologie Clinique, Assistance Publique–Hôpitaux de Paris ,(AP-HP), Hôpital Hôtel Dieu;Centre of Research Epidemiology and Statistics ,(CRESS), Inserm, INRA, Université de Paris;Assistance Publique-Hôpitaux de Paris;Department of Psychiatry, McGill University;Department of Epidemiology, Biostatistics, and Occupational Health, McGill University;Department of Psychology, McGill University;Department of Educational and Counselling Psychology, McGill University;Service de Médecine Interne, Centre de Référence Maladies Autoimmunes Systémiques Rares d’Ile de France, Hôpital Cochin;APHP-CUP, Hôpital Cochin

关键词: Feasibility trial;    Scleroderma;    Systemic sclerosis;    Tele-rehabilitation;    Internet intervention;    Physical therapy;    Occupational therapy;    Cohort multiple RCT;   

DOI  :  10.7717/peerj.13471

学科分类：社会科学、人文和艺术（综合）

来源: Inra

【 摘 要 】

PurposeThe Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlled trial of the SPIN-HAND program.Materials and MethodsThe feasibility trial was embedded in the SPIN cohort and utilized the cohort multiple randomized controlled trial (cmRCT) design. In the cmRCT design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about trials conducted using the cohort. When trials were conducted in the cohort, participants randomized to the intervention were informed and consented to access the intervention. Participants randomized to control were not informed that they have not received an intervention. All participants eligible and randomized to participate in the trial were included in analyses on an intent-to-treat basis. Cohort participants with a Cochin Hand Function Scale score ≥ 3/90 and an interest in using an online hand-exercise intervention were randomized (1:1 ratio) to be offered as usual care plus the SPIN-HAND Program or usual care for 3 months. User satisfaction was assessed with semi-structured interviews.ResultsOf the 40 randomized participants, 24 were allocated to SPIN-HAND and 16 to usual care. Of 24 participants randomized to be offered SPIN-HAND, 15 (63%) consented to use the program. Usage of SPIN-HAND content among the 15 participants who consented to use the program was low; only five (33%) logged in more than twice. Participants found the content relevant and easy to understand (satisfaction rating 8.5/10, N = 6). Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly. The required technical support was minimal.ConclusionsTrial methodology functioned as designed, and the SPIN-HAND Program was feasibly delivered; however, the acceptance of the offer and use of program content among accepters were low. Adjustments to information provided to potential participants will be implemented in the full-scale SPIN-HAND trial to attempt to increase offer acceptance.

【 授权许可】

CC BY