The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

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

doi:10.1186/s13063-021-05827-z

The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

Trials. 2021 Nov 27;22(1):856. doi: 10.1186/s13063-021-05827-z.

Authors

Julia Nordlund^#¹, Richard S Henry^#^{1

2}, Linda Kwakkenbos^{3

4}, Marie-Eve Carrier¹, Brooke Levis⁵, Warren R Nielson⁶, Susan J Bartlett^{7

8}, Laura Dyas⁹, Lydia Tao¹, Claire Fedoruk¹, Karen Nielsen¹⁰, Marie Hudson^{1

7}, Janet Pope¹¹, Tracy Frech¹², Shadi Gholizadeh¹³, Sindhu R Johnson^{14

15}, Pamela Piotrowski¹⁶, Lisa R Jewett¹⁷, Jessica Gordon¹⁸, Lorinda Chung^{19

20}, Dan Bilsker^{21

22}, Alexander W Levis²³, Kimberly A Turner¹, Julie Cumin¹, Joep Welling²⁴, Catherine Fortuné²⁵, Catarina Leite²⁶, Karen Gottesman²⁷, Maureen Sauve^{10

28}, Tatiana Sofía Rodríguez-Reyna²⁹, Maggie Larche³⁰, Ward van Breda³¹, Maria E Suarez-Almazor³², Amanda Wurz³³, Nicole Culos-Reed^{34

35

36}, Vanessa L Malcarne^{37

38}, Maureen D Mayes³⁹, Isabelle Boutron^{40

41}, Luc Mouthon^{42

43}, Andrea Benedetti^{7

44

45}, Brett D Thombs^{46

47

48

49

50

51

52

53}; SPIN Investigators

Collaborators

SPIN Investigators:
Robert Riggs, Shervin Assassi, Ghassan El-Baalbaki, Carolyn Ells, Cornelia van den Ende, Kim Fligelstone, Amy Gietzen, Geneviève Guillot, Daphna Harel, Monique Hinchcliff, Christelle Nguyen, François Rannou, Michelle Richard, Anne A Schouffoer, Christian Agard, Nassim Ait Abdallah, Alexandra Albert, Marc André, Elana J Bernstein, Sabine Berthier, Lyne Bissonnette, Alessandra Bruns, Patricia Carreira, Marion Casadevall, Benjamin Chaigne, Chase Correia, Benjamin Crichi, Christopher Denton, 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, Suzanne Kafaja, 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, John Varga, Pearce Wilcox, Angelica Bourgeault, Mara Cañedo Ayala, Andrea Carboni Jiménez, Marie-Nicole Discepola, Maria Gagarine, Nora Østbø

Affiliations

¹ Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, Quebec, H3T 1E2, Canada.
² Department of Psychiatry, McGill University, Montreal, Quebec, Canada.
³ Department of Clinical Psychology, Radboud University, Nijmegen, The Netherlands.
⁴ Department of Medical Psychology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
⁵ Centre for Prognosis Research, School of Medicine, Keele University, Keele, Staffordshire, UK.
⁶ St. Joseph's Health Care, London, Ontario, Canada.
⁷ Department of Medicine, McGill University, Montreal, Quebec, Canada.
⁸ Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
⁹ Scleroderma Foundation, Michigan Chapter, Southfield, MI, USA.
¹⁰ Scleroderma Society of Ontario, Hamilton, Ontario, Canada.
¹¹ Department of Medicine, University of Western Ontario, London, Ontario, Canada.
¹² Department of Internal Medicine, University of Utah, Salt Lake City, UT, USA.
¹³ California School of Professional Psychology/Alliant, Los Angeles, CA, USA.
¹⁴ Toronto Scleroderma Program, Mount Sinai Hospital & Toronto Western Hospital, Toronto, Ontario, Canada.
¹⁵ Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.
¹⁶ Private practice - Nutrition, Milton, Ontario, Canada.
¹⁷ Department of Psychology, Jewish General Hospital, Montreal, Quebec, Canada.
¹⁸ Department of Medicine, Hospital for Special Surgery, New York City, NY, USA.
¹⁹ Department of Medicine, Stanford University, Palo Alto, CA, USA.
²⁰ Department of Medicine, Palo Alto VA Health Care System, Palo Alto, CA, USA.
²¹ Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.
²² Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.
²³ Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA.
²⁴ NVLE Dutch patient organization for systemic autoimmune diseases, Utrecht, The Netherlands.
²⁵ Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada.
²⁶ University of Minho, Braga, Portugal.
²⁷ Scleroderma Foundation, Los Angeles, CA, USA.
²⁸ Scleroderma Canada, Hamilton, Ontario, Canada.
²⁹ Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
³⁰ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
³¹ Faculty of Behavioural and Movement Sciences, VU University, Amsterdam, The Netherlands.
³² Department of General Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
³³ School of Kinesiology, University of the Fraser Valley, Chilliwack, British Columbia, Canada.
³⁴ Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.
³⁵ Department of Oncology, Cumming School of Medicine, Calgary, Canada.
³⁶ Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.
³⁷ Department of Psychology, San Diego State University, San Diego, CA, USA.
³⁸ Joint Doctoral Program in Clinical Psychology, San Diego State University/University of California San Diego, San Diego, CA, USA.
³⁹ Department of Internal Medicine, University of Texas McGovern School of Medicine, Houston, TX, USA.
⁴⁰ Université de Paris, Centre of Research Epidemiology and Statistics (CRESS), Inserm, INRA, Paris, France.
⁴¹ Centre d'Épidémiologie Clinique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Paris, France.
⁴² 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.
⁴³ APHP-CUP, Hôpital Cochin, Université de Paris, F-75014, Paris, France.
⁴⁴ Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.
⁴⁵ Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.
⁴⁶ Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, Quebec, H3T 1E2, Canada. [email protected].
⁴⁷ Department of Psychiatry, McGill University, Montreal, Quebec, Canada. [email protected].
⁴⁸ Department of Medicine, McGill University, Montreal, Quebec, Canada. [email protected].
⁴⁹ Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada. [email protected].
⁵⁰ Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada. [email protected].
⁵¹ Department of Psychology, McGill University, Montreal, Quebec, Canada. [email protected].
⁵² Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada. [email protected].
⁵³ Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. [email protected].

^# Contributed equally.

Abstract

Background: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary).

Methods: This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort ( http://www.spinsclero.com/en/cohort ) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited.

Discussion: The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge.

Trial registration: ClinicalTrials.gov NCT04246528 . Registered on 27 January 2020.

Keywords: Patient activation; Randomized controlled trial; Scleroderma; Self-efficacy; Self-management; Systemic sclerosis; e-Health.

Publication types

Clinical Trial Protocol

MeSH terms

COVID-19*
Feasibility Studies
Humans
Patient-Centered Care
Randomized Controlled Trials as Topic
Scleroderma, Systemic*
Self-Management*

Associated data

ClinicalTrials.gov/NCT04246528

Grants and funding

201603PJT/CAPMC/ CIHR/Canada