Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program.
Cohort multiple RCT
Feasibility trial
Internet intervention
Scleroderma
Self-management
Systemic sclerosis
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
26 Feb 2022
26 Feb 2022
Historique:
received:
10
05
2021
accepted:
27
01
2022
entrez:
27
2
2022
pubmed:
28
2
2022
medline:
28
2
2022
Statut:
epublish
Résumé
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. 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. 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). 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. clinicaltrials.gov , NCT03914781 . Registered 16 April 2019.
Sections du résumé
BACKGROUND
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
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
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
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
BACKGROUND
clinicaltrials.gov , NCT03914781 . Registered 16 April 2019.
Identifiants
pubmed: 35219340
doi: 10.1186/s40814-022-00994-5
pii: 10.1186/s40814-022-00994-5
pmc: PMC8881754
doi:
Banques de données
ClinicalTrials.gov
['NCT03914781']
Types de publication
Journal Article
Langues
eng
Pagination
45Subventions
Organisme : CIHR
ID : TR3-119192
Pays : Canada
Organisme : CIHR
ID : PJT-148504
Pays : Canada
Investigateurs
Laura K Hummers
(LK)
Robert Riggs
(R)
Shervin Assassi
(S)
Ghassan El-Baalbaki
(G)
Carolyn Ells
(C)
Kim Fligelstone
(K)
Amy Gietzen
(A)
Geneviève Guillot
(G)
Daphna Harel
(D)
Monique Hinchcliff
(M)
Christelle Nguyen
(C)
François Rannou
(F)
Karen Nielsen
(K)
Michelle Richard
(M)
Anne A Schouffoer
(AA)
Christian Agard
(C)
Nassim Ait Abdallah
(NA)
Alexandra Albert
(A)
Marc André
(M)
Elana J Bernstein
(EJ)
Sabine Berthier
(S)
Lyne Bissonnette
(L)
Alessandra Bruns
(A)
Marion Casadevall
(M)
Benjamin Chaigne
(B)
Chase Correia
(C)
Benjamin Crichi
(B)
Robyn Domsic
(R)
James V Dunne
(JV)
Bertrand Dunogue
(B)
Regina Fare
(R)
Dominique Farge-Bancel
(D)
Paul R Fortin
(PR)
Brigitte Granel-Rey
(B)
Genevieve Gyger
(G)
Eric Hachulla
(E)
Ariane L Herrick
(AL)
Sabrina Hoa
(S)
Alena Ikic
(A)
Niall Jones
(N)
Nader Khalidi
(N)
Marc Lambert
(M)
David Launay
(D)
Hélène Maillard
(H)
Nancy Maltez
(N)
Joanne Manning
(J)
Isabelle Marie
(I)
Maria Martin
(M)
Thierry Martin
(T)
Ariel Masetto
(A)
François Maurier
(F)
Arsene Mekinian
(A)
Sheila Melchor
(S)
Mandana Nikpour
(M)
Louis Olagne
(L)
Vincent Poindron
(V)
Susanna Proudman
(S)
Alexis Régent
(A)
Sébastien Rivière
(S)
David Robinson
(D)
Esther Rodriguez
(E)
Sophie Roux
(S)
Perrine Smets
(P)
Vincent Sobanski
(V)
Robert Spiera
(R)
Virginia Steen
(V)
Evelyn Sutton
(E)
Carter Thorne
(C)
Pearce Wilcox
(P)
Angelica Bourgeault
(A)
Mara Cañedo Ayala
(MC)
Andrea Carboni Jiménez
(AC)
Marie-Nicole Discepola
(MN)
Maria Gagarine
(M)
Julia Nordlund
(J)
Informations de copyright
© 2022. The Author(s).
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