Randomized feasibility trial of the Scleroderma patient-centered intervention network hand exercise program (SPIN-HAND): Study protocol

SPIN Investigators

Research output: Contribution to journalArticle

Abstract

Background: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. Design and methods: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale ≥3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. Discussion: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. Trial registration: ClinicalTrials.gov Identifier: NCT03092024.

Original languageEnglish (US)
Pages (from-to)91-97
Number of pages7
JournalJournal of Scleroderma and Related Disorders
Volume3
Issue number1
DOIs
StatePublished - Oct 16 2017

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Hand
Exercise
Randomized Controlled Trials
Pragmatic Clinical Trials
Systemic Scleroderma
Rehabilitation

Keywords

  • Feasibility studies
  • Scleroderma
  • Systemic
  • Tele-rehabilitation
  • Trial protocols

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

@article{77f27bd16a90452e97fab1c372685b40,
title = "Randomized feasibility trial of the Scleroderma patient-centered intervention network hand exercise program (SPIN-HAND): Study protocol",
abstract = "Background: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. Design and methods: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale ≥3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. Discussion: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. Trial registration: ClinicalTrials.gov Identifier: NCT03092024.",
keywords = "Feasibility studies, Scleroderma, Systemic, Tele-rehabilitation, Trial protocols",
author = "{SPIN Investigators} and Carrier, {Marie Eve} and Linda Kwakkenbos and Isabelle Boutron and Joep Welling and Maureen Sauve and {van den Ende}, Cornelia and Schouffoer, {Anne A.} and Marie Hudson and Thombs, {Brett D.} and Luc Mouthon and Murray Baron and Bartlett, {Susan J.} and Dan Furst and Karen Gottesman and {van den Hoogen}, Frank and Vanessa Malcarne and Mayes, {Maureen D.} and Nielson, {Warren R.} and Robert Riggs and Fredrick Wigley and Shervin Assassi and Maia, {Angela Costa} and Ghassan El-Baalbaki and Carolyn Ells and Kim Fligelstone and Catherine Fortune and Tracy Frech and Dominique Godard and Daphna Harel and Ann Impens and Yeona Jang and Johnson, {Sindhu R.} and Kennedy, {Ann Tyrell} and Annett K{\"o}rner and Maggie Larche and Catarina Leite and Carlo Marra and Karen Nielsen and Janet Pope and Alexandra Portales and Reyna, {Tatiana Sofia Rodriguez} and Steele, {Russell J.} and Suarez-Almazor, {Maria E.} and Durhane Wong-Rieger and Christian Agard and Alexandra Albert and Marc Andr{\'e} and Guylaine Arsenault and Nouria Benmostefa and Ilham Benzida",
year = "2017",
month = "10",
day = "16",
doi = "10.5301/jsrd.5000263",
language = "English (US)",
volume = "3",
pages = "91--97",
journal = "Journal of Scleroderma and Related Disorders",
issn = "2397-1983",
publisher = "SAGE Publications Ltd",
number = "1",

}

TY - JOUR

T1 - Randomized feasibility trial of the Scleroderma patient-centered intervention network hand exercise program (SPIN-HAND)

T2 - Study protocol

AU - SPIN Investigators

AU - Carrier, Marie Eve

AU - Kwakkenbos, Linda

AU - Boutron, Isabelle

AU - Welling, Joep

AU - Sauve, Maureen

AU - van den Ende, Cornelia

AU - Schouffoer, Anne A.

AU - Hudson, Marie

AU - Thombs, Brett D.

AU - Mouthon, Luc

AU - Baron, Murray

AU - Bartlett, Susan J.

AU - Furst, Dan

AU - Gottesman, Karen

AU - van den Hoogen, Frank

AU - Malcarne, Vanessa

AU - Mayes, Maureen D.

AU - Nielson, Warren R.

AU - Riggs, Robert

AU - Wigley, Fredrick

AU - Assassi, Shervin

AU - Maia, Angela Costa

AU - El-Baalbaki, Ghassan

AU - Ells, Carolyn

AU - Fligelstone, Kim

AU - Fortune, Catherine

AU - Frech, Tracy

AU - Godard, Dominique

AU - Harel, Daphna

AU - Impens, Ann

AU - Jang, Yeona

AU - Johnson, Sindhu R.

AU - Kennedy, Ann Tyrell

AU - Körner, Annett

AU - Larche, Maggie

AU - Leite, Catarina

AU - Marra, Carlo

AU - Nielsen, Karen

AU - Pope, Janet

AU - Portales, Alexandra

AU - Reyna, Tatiana Sofia Rodriguez

AU - Steele, Russell J.

AU - Suarez-Almazor, Maria E.

AU - Wong-Rieger, Durhane

AU - Agard, Christian

AU - Albert, Alexandra

AU - André, Marc

AU - Arsenault, Guylaine

AU - Benmostefa, Nouria

AU - Benzida, Ilham

PY - 2017/10/16

Y1 - 2017/10/16

N2 - Background: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. Design and methods: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale ≥3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. Discussion: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. Trial registration: ClinicalTrials.gov Identifier: NCT03092024.

AB - Background: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. Design and methods: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale ≥3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. Discussion: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. Trial registration: ClinicalTrials.gov Identifier: NCT03092024.

KW - Feasibility studies

KW - Scleroderma

KW - Systemic

KW - Tele-rehabilitation

KW - Trial protocols

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U2 - 10.5301/jsrd.5000263

DO - 10.5301/jsrd.5000263

M3 - Article

AN - SCOPUS:85055963245

VL - 3

SP - 91

EP - 97

JO - Journal of Scleroderma and Related Disorders

JF - Journal of Scleroderma and Related Disorders

SN - 2397-1983

IS - 1

ER -