TY - JOUR
T1 - The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program
T2 - protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
AU - on behalf of the SPIN Investigators
AU - Nordlund, Julia
AU - Henry, Richard S.
AU - Kwakkenbos, Linda
AU - Carrier, Marie Eve
AU - Levis, Brooke
AU - Nielson, Warren R.
AU - Bartlett, Susan J.
AU - Dyas, Laura
AU - Tao, Lydia
AU - Fedoruk, Claire
AU - Nielsen, Karen
AU - Hudson, Marie
AU - Pope, Janet
AU - Frech, Tracy
AU - Gholizadeh, Shadi
AU - Johnson, Sindhu R.
AU - Piotrowski, Pamela
AU - Jewett, Lisa R.
AU - Gordon, Jessica
AU - Chung, Lorinda
AU - Bilsker, Dan
AU - Levis, Alexander W.
AU - Turner, Kimberly A.
AU - Cumin, Julie
AU - Welling, Joep
AU - Fortuné, Catherine
AU - Leite, Catarina
AU - Gottesman, Karen
AU - Sauve, Maureen
AU - Rodríguez-Reyna, Tatiana Sofía
AU - Larche, Maggie
AU - van Breda, Ward
AU - Suarez-Almazor, Maria E.
AU - Wurz, Amanda
AU - Culos-Reed, Nicole
AU - Malcarne, Vanessa L.
AU - Mayes, Maureen D.
AU - Boutron, Isabelle
AU - Mouthon, Luc
AU - Benedetti, Andrea
AU - Thombs, Brett D.
AU - Riggs, Robert
AU - Assassi, Shervin
AU - El-Baalbaki, Ghassan
AU - Ells, Carolyn
AU - van den Ende, Cornelia
AU - Fligelstone, Kim
AU - Gietzen, Amy
AU - Guillot, Geneviève
AU - Harel, Daphna
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.govNCT04246528. Registered on 27 January 2020.
AB - 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.govNCT04246528. Registered on 27 January 2020.
KW - Patient activation
KW - Randomized controlled trial
KW - Scleroderma
KW - Self-efficacy
KW - Self-management
KW - Systemic sclerosis
KW - e-Health
UR - http://www.scopus.com/inward/record.url?scp=85122276353&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85122276353&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05827-z
DO - 10.1186/s13063-021-05827-z
M3 - Article
C2 - 34838105
AN - SCOPUS:85122276353
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 856
ER -