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Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8881754/ https://www.ncbi.nlm.nih.gov/pubmed/35219340 http://dx.doi.org/10.1186/s40814-022-00994-5 |
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author | Kwakkenbos, Linda Østbø, Nora Carrier, Marie-Eve Nielson, Warren R. Fedoruk, Claire Levis, Brooke Henry, Richard S. Pope, Janet Frech, Tracy Gholizadeh, Shadi Johnson, Sindhu R. Piotrowski, Pamela Jewett, Lisa R. Gordon, Jessica Chung, Lorinda Bilsker, Dan Tao, Lydia Turner, Kimberly A. Cumin, Julie Welling, Joep Fortuné, Catherine Leite, Catarina Gottesman, Karen Sauvé, Maureen Reyna, Tatiana Sofia Rodriguez Hudson, Marie Larche, Maggie van Breda, Ward Suarez-Almazor, Maria E. Bartlett, Susan J. Malcarne, Vanessa L. Mayes, Maureen D. Boutron, Isabelle Mouthon, Luc Benedetti, Andrea Thombs, Brett D. |
author_facet | Kwakkenbos, Linda Østbø, Nora Carrier, Marie-Eve Nielson, Warren R. Fedoruk, Claire Levis, Brooke Henry, Richard S. Pope, Janet Frech, Tracy Gholizadeh, Shadi Johnson, Sindhu R. Piotrowski, Pamela Jewett, Lisa R. Gordon, Jessica Chung, Lorinda Bilsker, Dan Tao, Lydia Turner, Kimberly A. Cumin, Julie Welling, Joep Fortuné, Catherine Leite, Catarina Gottesman, Karen Sauvé, Maureen Reyna, Tatiana Sofia Rodriguez Hudson, Marie Larche, Maggie van Breda, Ward Suarez-Almazor, Maria E. Bartlett, Susan J. Malcarne, Vanessa L. Mayes, Maureen D. Boutron, Isabelle Mouthon, Luc Benedetti, Andrea Thombs, Brett D. |
author_sort | Kwakkenbos, Linda |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8881754 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-88817542022-02-28 Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program Kwakkenbos, Linda Østbø, Nora Carrier, Marie-Eve Nielson, Warren R. Fedoruk, Claire Levis, Brooke Henry, Richard S. Pope, Janet Frech, Tracy Gholizadeh, Shadi Johnson, Sindhu R. Piotrowski, Pamela Jewett, Lisa R. Gordon, Jessica Chung, Lorinda Bilsker, Dan Tao, Lydia Turner, Kimberly A. Cumin, Julie Welling, Joep Fortuné, Catherine Leite, Catarina Gottesman, Karen Sauvé, Maureen Reyna, Tatiana Sofia Rodriguez Hudson, Marie Larche, Maggie van Breda, Ward Suarez-Almazor, Maria E. Bartlett, Susan J. Malcarne, Vanessa L. Mayes, Maureen D. Boutron, Isabelle Mouthon, Luc Benedetti, Andrea Thombs, Brett D. Pilot Feasibility Stud Research 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. BioMed Central 2022-02-26 /pmc/articles/PMC8881754/ /pubmed/35219340 http://dx.doi.org/10.1186/s40814-022-00994-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Kwakkenbos, Linda Østbø, Nora Carrier, Marie-Eve Nielson, Warren R. Fedoruk, Claire Levis, Brooke Henry, Richard S. Pope, Janet Frech, Tracy Gholizadeh, Shadi Johnson, Sindhu R. Piotrowski, Pamela Jewett, Lisa R. Gordon, Jessica Chung, Lorinda Bilsker, Dan Tao, Lydia Turner, Kimberly A. Cumin, Julie Welling, Joep Fortuné, Catherine Leite, Catarina Gottesman, Karen Sauvé, Maureen Reyna, Tatiana Sofia Rodriguez Hudson, Marie Larche, Maggie van Breda, Ward Suarez-Almazor, Maria E. Bartlett, Susan J. Malcarne, Vanessa L. Mayes, Maureen D. Boutron, Isabelle Mouthon, Luc Benedetti, Andrea Thombs, Brett D. Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program |
title | Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program |
title_full | Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program |
title_fullStr | Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program |
title_full_unstemmed | Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program |
title_short | Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program |
title_sort | randomized feasibility trial of the scleroderma patient-centered intervention network self-management (spin-self) program |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8881754/ https://www.ncbi.nlm.nih.gov/pubmed/35219340 http://dx.doi.org/10.1186/s40814-022-00994-5 |
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