Title :

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

Author(s) :

Kwakkenbos, Linda [Auteur]
Østbø, Nora [Auteur]
Carrier, Marie-Eve [Auteur]
Nielson, Warren [Auteur]
Fedoruk, Claire [Auteur]
Levis, Brooke [Auteur]
Henry, Richard [Auteur]
Pope, Janet [Auteur]
Frech, Tracy [Auteur]
Gholizadeh, Shadi [Auteur]
Johnson, Sindhu [Auteur]
Piotrowski, Pamela [Auteur]
Jewett, Lisa [Auteur]
Gordon, Jessica [Auteur]
Chung, Lorinda [Auteur]
Bilsker, Dan [Auteur]
Tao, Lydia [Auteur]
Turner, Kimberly [Auteur]
Cumin, Julie [Auteur]
Welling, Joep [Auteur]
Fortuné, Catherine [Auteur]
Leite, Catarina [Auteur]
Gottesman, Karen [Auteur]
Sauvé, Maureen [Auteur]
Reyna, Tatiana Sofia Rodriguez [Auteur]
Hudson, Marie [Auteur]
Larche, Maggie [Auteur]
van Breda, Ward [Auteur]
Suarez-Almazor, Maria [Auteur]
Bartlett, Susan [Auteur]
Malcarne, Vanessa [Auteur]
Mayes, Maureen [Auteur]
Boutron, Isabelle [Auteur]
Mouthon, Luc [Auteur]
Benedetti, Andrea [Auteur]
Thombs, Brett [Auteur]
Hummers, Laura [Auteur]
Riggs, Robert [Auteur]
Assassi, Shervin [Auteur]
El-Baalbaki, Ghassan [Auteur]
Ells, Carolyn [Auteur]
Fligelstone, Kim [Auteur]
Gietzen, Amy [Auteur]
Guillot, Geneviève [Auteur]
Harel, Daphna [Auteur]
Hinchcliff, Monique [Auteur]
Nguyen, Christelle [Auteur]
Rannou, François [Auteur]
Nielsen, Karen [Auteur]
Richard, Michelle [Auteur]
Schouffoer, Anne [Auteur]
Agard, Christian [Auteur]
Abdallah, Nassim Ait [Auteur]
Albert, Alexandra [Auteur]
André, Marc [Auteur]
Bernstein, Elana [Auteur]
Berthier, Sabine [Auteur]
Bissonnette, Lyne [Auteur]
Bruns, Alessandra [Auteur]
Casadevall, Marion [Auteur]
Chaigne, Benjamin [Auteur]
Correia, Chase [Auteur]
Crichi, Benjamin [Auteur]
Domsic, Robyn [Auteur]
Dunne, James [Auteur]
Dunogue, Bertrand [Auteur]
Fare, Regina [Auteur]
Farge-Bancel, Dominique [Auteur]
Fortin, Paul [Auteur]
Granel-Rey, Brigitte [Auteur]
Gyger, Genevieve [Auteur]
Hachulla, Eric [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Herrick, Ariane [Auteur]
Hoa, Sabrina [Auteur]
Ikic, Alena [Auteur]
Jones, Niall [Auteur]
Khalidi, Nader [Auteur]
Lambert, Marc [Auteur]
Facteurs de risque et déterminants moléculaires des maladies liées au vieillissement (RID-AGE) - U1167
Facteurs de Risque et Déterminants Moléculaires des Maladies liées au Vieillissement - U 1167 [RID-AGE]
Launay, David [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Maillard, Hélène [Auteur]
Maltez, Nancy [Auteur]
Manning, Joanne [Auteur]
Marie, Isabelle [Auteur]
Martin, Maria [Auteur]
Martin, Thierry [Auteur]
Masetto, Ariel [Auteur]
Maurier, François [Auteur]
Mekinian, Arsene [Auteur]
Melchor, Sheila [Auteur]
Nikpour, Mandana [Auteur]
Olagne, Louis [Auteur]
Poindron, Vincent [Auteur]
Proudman, Susanna [Auteur]
Régent, Alexis [Auteur]
Rivière, Sébastien [Auteur]
Robinson, David [Auteur]
Rodriguez, Esther [Auteur]
Roux, Sophie [Auteur]
Smets, Perrine [Auteur]
Sobanski, Vincent [Auteur]
Spiera, Robert [Auteur]
Steen, Virginia [Auteur]
Sutton, Evelyn [Auteur]
Thorne, Carter [Auteur]
Wilcox, Pearce [Auteur]
Bourgeault, Angelica [Auteur]
Ayala, Mara Cañedo [Auteur]
Jiménez, Andrea Carboni [Auteur]
Discepola, Marie-Nicole [Auteur]
Gagarine, Maria [Auteur]
Nordlund, Julia [Auteur]

Journal title :

Pilot and Feasibility Studies

Pages :

45

Publisher :

BioMed Central

Publication date :

2022-02-26

ISSN :

2055-5784

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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 ...
Show more >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.Show less >

Language :

Anglais

Popular science :

Non

Collections :

• Facteurs de risque et déterminants moléculaires des maladies liées au vieillissement (RID-AGE) - U1167

Source :

Harvested from HAL

Submission date :

2024-01-29T04:41:30Z