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

Linda Kwakkenbos; Nora Østbø; Marie-Eve Carrier; Warren R Nielson; Claire Fedoruk; Brooke Levis; Richard S Henry; Janet Pope; Tracy Frech; Shadi Gholizadeh; Sindhu R Johnson; Pamela Piotrowski; Lisa R Jewett; Jessica Gordon; Lorinda Chung; Dan Bilsker; Lydia Tao; Kimberly A Turner; Julie Cumin; Joep Welling; Catherine Fortuné; Catarina Leite; Karen Gottesman; Maureen Sauvé; Tatiana Sofia Rodriguez Reyna; Marie Hudson; Maggie Larche; Ward van Breda; Maria E Suarez-Almazor; Susan J Bartlett; Vanessa L Malcarne; Maureen D Mayes; Isabelle Boutron; Luc Mouthon; Andrea Benedetti; Brett D Thombs; SPIN Investigators

doi:10.1186/s40814-022-00994-5

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

Pilot Feasibility Stud. 2022 Feb 26;8(1):45. doi: 10.1186/s40814-022-00994-5.

Authors

Linda Kwakkenbos¹, Nora Østbø², Marie-Eve Carrier², Warren R Nielson³, Claire Fedoruk², Brooke Levis⁴, Richard S Henry^{2

5}, Janet Pope⁶, Tracy Frech⁷, Shadi Gholizadeh⁸, Sindhu R Johnson^{9

10}, Pamela Piotrowski¹¹, Lisa R Jewett¹², Jessica Gordon¹³, Lorinda Chung^{14

15}, Dan Bilsker^{16

17}, Lydia Tao², Kimberly A Turner², Julie Cumin², Joep Welling¹⁸, Catherine Fortuné¹⁹, Catarina Leite²⁰, Karen Gottesman²¹, Maureen Sauvé^{22

23}, Tatiana Sofia Rodriguez Reyna²⁴, Marie Hudson^{2

25}, Maggie Larche²⁶, Ward van Breda²⁷, Maria E Suarez-Almazor²⁸, Susan J Bartlett^{25

29}, Vanessa L Malcarne^{30

31}, Maureen D Mayes³², Isabelle Boutron^{33

34}, Luc Mouthon^{35

36}, Andrea Benedetti^{25

37

38}, Brett D Thombs^{2

5

25

37

39

40

41}; SPIN Investigators

Collaborators

SPIN Investigators:
Laura K Hummers, Robert Riggs, Shervin Assassi, Ghassan El-Baalbaki, Carolyn Ells, Kim Fligelstone, Amy Gietzen, Geneviève Guillot, Daphna Harel, Monique Hinchcliff, Christelle Nguyen, François Rannou, Karen Nielsen, Michelle Richard, Anne A Schouffoer, Christian Agard, Nassim Ait Abdallah, Alexandra Albert, Marc André, Elana J Bernstein, Sabine Berthier, Lyne Bissonnette, Alessandra Bruns, Marion Casadevall, Benjamin Chaigne, Chase Correia, Benjamin Crichi, Robyn Domsic, James V Dunne, Bertrand Dunogue, Regina Fare, Dominique Farge-Bancel, Paul R Fortin, Brigitte Granel-Rey, Genevieve Gyger, Eric Hachulla, Ariane L Herrick, Sabrina Hoa, Alena Ikic, Niall Jones, Nader Khalidi, Marc Lambert, David Launay, Hélène Maillard, Nancy Maltez, Joanne Manning, Isabelle Marie, Maria Martin, Thierry Martin, Ariel Masetto, François Maurier, Arsene Mekinian, Sheila Melchor, Mandana Nikpour, Louis Olagne, Vincent Poindron, Susanna Proudman, Alexis Régent, Sébastien Rivière, David Robinson, Esther Rodriguez, Sophie Roux, Perrine Smets, Vincent Sobanski, Robert Spiera, Virginia Steen, Evelyn Sutton, Carter Thorne, Pearce Wilcox, Angelica Bourgeault, Mara Cañedo Ayala, Andrea Carboni Jiménez, Marie-Nicole Discepola, Maria Gagarine, Julia Nordlund

Affiliations

¹ Department of Clinical Psychology, Radboud University, Montessorilaan 3, 6525, HR, Nijmegen, The Netherlands. [email protected].
² Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
³ St. Joseph's Health Care, London, Ontario, Canada.
⁴ Centre for Prognosis Research, School of Medicine, Keele University, Staffordshire, UK.
⁵ Department of Psychiatry, McGill University, Montreal, Quebec, Canada.
⁶ Department of Medicine, University of Western Ontario, London, Ontario, Canada.
⁷ Department of Internal Medicine, University of Utah, Salt Lake City, UT, USA.
⁸ California School of Professional Psychology/Alliant, Los Angeles, CA, USA.
⁹ Toronto Scleroderma Program, Mount Sinai Hospital & Toronto Western Hospital, Toronto, Ontario, Canada.
¹⁰ Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹¹ Private practice - Nutrition, Hamilton, Ontario, Canada.
¹² Department of Psychology, Institute of Community and Family Psychiatry, Jewish General Hospital, Montreal, Quebec, Canada.
¹³ Department of Medicine, Hospital for Special Surgery, New York City, NY, USA.
¹⁴ Department of Medicine, Stanford University, Palo Alto, CA, USA.
¹⁵ Department of Medicine Palo Alto VA Health Care System, Palo Alto, CA, USA.
¹⁶ Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.
¹⁷ Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.
¹⁸ NVLE Dutch patient organization for Systemic Autoimmune Diseases, Utrecht, The Netherlands.
¹⁹ Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada.
²⁰ University of Minho, Braga, Portugal.
²¹ Scleroderma Foundation, Los Angeles, CA, USA.
²² Scleroderma Canada, Hamilton, Ontario, Canada.
²³ Scleroderma Society of Ontario, Hamilton, Ontario, Canada.
²⁴ Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, Mexico.
²⁵ Department of Medicine, McGill University, Montreal, Quebec, Canada.
²⁶ Department of Medicine, McMaster University and St Joseph's Healthcare, Hamilton, Ontario, Canada.
²⁷ Faculty of Behavioural and Movement Sciences, Vrije University, Amsterdam, The Netherlands.
²⁸ Department of General Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
²⁹ Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
³⁰ Department of Psychology, San Diego State University, San Diego, CA, USA.
³¹ Joint Doctoral Program in Clinical Psychology, San Diego State University/University of California San Diego, San Diego, CA, USA.
³² Department of Internal Medicine, University of Texas McGovern School of Medicine, Houston, TX, USA.
³³ Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), Inserm, INRA, Paris, France.
³⁴ Centre d'Épidémiologie Clinique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Paris, France.
³⁵ 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.
³⁶ APHP-CUP, Hôpital Cochin, Université de Paris, F-75014, Paris, France.
³⁷ Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.
³⁸ Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.
³⁹ Department of Psychology, McGill University, Montreal, Quebec, Canada.
⁴⁰ Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada.
⁴¹ Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.

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.

Keywords: Cohort multiple RCT; Feasibility trial; Internet intervention; Scleroderma; Self-management; Systemic sclerosis.

Associated data

ClinicalTrials.gov/NCT03914781

Abstract

Associated data

Grants and funding