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

SPIN Investigators

doi:10.5301/jsrd.5000263

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

SPIN Investigators

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

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 language	English (US)
Pages (from-to)	91-97
Number of pages	7
Journal	Journal of Scleroderma and Related Disorders
Volume	3
Issue number	1
DOIs	https://doi.org/10.5301/jsrd.5000263
State	Published - Feb 1 2018

Funding

Sherbrooke ? Quebec ? Canada \u5600 Nouria Benmostefa ? Assistance oPfu Mb ?anitoba ? ?innipeg ? Manitoba ? Canada \u5600 Esther Rodriguez ? Servi ? lique H\u00F4pitaux de Paris \u7200 H\u00F4pital Cochin ? Paris ? France \u5600 Ilham Bencziiod ad ?e Reumatologia del Hospital \uED03\uEE00 de Octubre ? Madrid ? Spain \u5600 So ? Assistance Publique H\u00F4pitaux de Paris \u7200 H\u00F4pital St \u7200Louis ? Paris ? Frapnhciee ? Roux \u5500 Universit\u00E9 de Sherbrooke ? Sherbrooke ? Quebec ? Canada ? Sabine Berthier?Centre Hospitalier Universitaire Dijon Bourgogne ?Di?PerrineSmets ?Centre Hospitalier Universitaire Gabriel \u7200Montpied ?Cl? jon ? France ? Lyne Bissonnette ? Universit\u00E9 de Sherbrooke ? Sherbroeorkmeo ? nt \u7200Ferrand ? France \u5600 Doug Smith ? University of Ottawa ? Ottawa ? Quebec ? Canada ? Gilles Boire ? Universit\u00E9 de Sherbrooke ? SherbroOonktea ?rio ? Canada \u5600 Vincent Sobanski \u5500 Centre Hospitalier R\u00E9gional Uni ? Quebec ? Canada \u5600 Alessandra Bruns ? Universit\u00E9 de Sherbrooke ? ?Shevrersitaire de Lille \u7200 H\u00F4pital Claude Huriez ? Lille ? France \u5600 Robert Spiera ? brooke ? Quebec ? Canada \u5600 Patricia Carreira ? Servicio de ReumatoHloogsiapital for Special Surgery ? New York ? New York ? USA ? Virginia Steen ? del Hospital \uED03\uEE00 de Octubre ?Madrid ?Spain \u5600 Marion Casadevall ?GeAosrsgiest?own University?? ashington ?DC?USA \u5600 Evelyn Sutton ?Dalhou? tance Publique H\u00F4pitaux de Paris \u7200 H\u00F4pital Cochin ? Paris ? France \u5600 sBieenU?niversity ? Halifax ? Nova Scotia ? Canada \u5600 Benjamin Terrier ? Assis ? jamin Chaigne ? Assistance Publique H\u00F4pitaux de Paris \u7200 H\u00F4pitaltance Publique H\u00F4pitaux de Paris \u7200 H\u00F4pital Cochin ? Paris ? France ? Cochin \u5500 Paris ? France \u5600 Lorinda Chung ? Stanford University ? StCanarfoterrd T? horne ? Southlake Regional Health Centre ? Newmarket ? On ? California ? USA \u5600 Pascal Cohen ? Assistance Publique H\u00F4pitaux de Patraisrio ? Canada \u5600 John Varga ? Northwestern University ? Chicago ? Illinois ? \u7200 H\u00F4pital Cochin \u5500 Paris ? France \u5600Da gPeienrareis ? Universit\u00E9 de She?r USA ? Pearce ?ilcox ? St \u5800 Paul ? s Hospital and University of British Co ? brooke ? Sherbrooke? Quebec ? Canada \u5600 Christopher Denton ? lumRobyiaal ? Vancouver? British Columbia ? Canada \u5600 Julie Cumin ? Jewish Free London Hospital ? London ? UK \u5600 Robyn Domsic ? University of PGiettnse?ral Hospital ? Montreal \u5500 Quebec ? Canada \u5600 Rina S \u5800 Fox ? San Diego burgh ?Pittsburgh ?Pennsylvania ?USA ?James V\u5800 Dunne ?St \u5800S tPaatuel U? nsiv Heorssit?y and University of California ? San Diego? San Diego? pital and University of British Columbia ? Vancouver ? British Columbia C? alifornia ? USA \u5600 Shadi Gholizadeh ? San Diego State University and Uni ? Canada \u5600 Regina Fare ? Servicio de Reumatologia del Hospital \uED03\uEE00 vdeersity of California ? San Diego ? San Diego ? California ? USA \u5600? Lisa R \u5800 Jew Octubre ? Madrid ? Spain \u5600 Dominique Farge \u7200Bancel ? Assistance ePtutb ? ?Jewish General Hospital and McGill University ? Montr\u00E9al ? Qu\u00E9bec ? liqueH\u00F4pitaux de Paris \u7200 H\u00F4pital SLto?uis ? Paris ?France \u5600 Paul R\u5800 FoCratinna ?da ? Brooke Levis ?Jewish General Hospital and McGill University? CHU de Qu\u00E9bec \u7200 Universit\u00E9 Laval ? Quebec ? Quebec ? Canada \u5600M Aonntnraeal ? Quebec ? Canada \u5600 Sarah D \u5800 Mills ? San Diego State University Gill ?Royal FreeLondon Hospital ?London ?UK\u5600 Jessica Gordon ?Haonsdp iUtanliversity of California ? San Diego? San Diego? California ? USA ? for Special Surgery ? New York City ? New York ? USA \u5600 Brigitte GranelM \u7200iaR eRy\u5800? Pepin ? Jewish General Hospital ? Montreal ? Quebec ? Canada ? Aix Marseille Universit\u00E9 ? and Assistance Publique H\u00F4pitaux de Kimberly Turner?Jewish General HospitaMl ?ontreal ?Quebec \u5500 Canada ? Marseille \u7200 H\u00F4pital Nord ? Marseille ? France \u5600 Claire Grange ? Centre HTohse?SPIN team is dedicating the SPIN \u7200HAND program to the mem ? pitalier Lyon Sud ?Lyon ?France\u5600 Genevieve Gyger?Jewish General oHroys o?f Dr\u5800 SergePoiraudeau ?who led the SPIN\u7200HAND project team ? pital and McGill University?Montreal ?Quebec ?Canada \u5600 Eric Hachaulollna g? with Dr\u5800 Luc Mouthon \u5800 Dr\u5800 Poiraudeau cared deeply for thequal? Centre Hospitalier R\u00E9gional Universitaire de Lille \u7200H\u00F4pital Claude Hu ?ity of life and well \u7201\u0F01?ing of people living with scleroderma ? and with ? riez ?Lille ?FraPniceerr\u5600e ? Yves Hatron ?CentreHospitalier R\u00E9gional Uni?out his leadership and dedication the SPIN\u7200HAND program would not versitaire de Lille \u7200 H\u00F4pital Claude Huriez ? Lille ? France \u5600 AriahnaeveL been possible ? Herrick ? University of Manchester ? Salford Royal NHS Foundation Trust ? Manchester ? UK \u5600 Adrian Hij ? Assistance Publique H\u00F4pitauDx idseclosures Paris \u7200 H\u00F4pital St\u7200Louis ?Paris ?France\u5600 Monique Hinchcliff?? Northwest Financial support P SPIN \u5500 including the present feasibility trial \u5500 has ern University ? Chicago ? Illinois ? USA \u5600 Alena Ikic ? Universit\u00E9?Laval ?been Quefunded by grants from the Canadian Institutes of Health bec ? Quebec ? Canada \u5600 Niall Jones ? University of Alberta ? EdmonResearton ?ch \u7E00TR \uEF03\u7203\uED03\uED03\uF503\uED03\uF503\uEE03\u5500 PJT\u7203\uED03\uF003\uF403\uF103\uEC03\uF003\u5500 PJT\u7203\uED03\uF003\uF503\uEC03\uF303\uEF03\u7F00 Alberta ? Canada ? Artur Jose de B \u5800 Fernandes ? Universit\u00E9?de SShoecriety \u5800 In addition \u5500 SPIN has received institutional contributions brooke ? Sherbrooke ? Quebec ? Canada \u5600 Suzanne Kafaja ? Univefrrsoitmy otfhe Lady Davis Institute for Medical Research of the Jewish California ? Los Angeles ? California ? USA \u5600 Nader Khalidi ? McMastGenerer Unial ?Hospital \u5500 Montreal \u5500 Canada and from McGill University \u5500 versity?Hamilton ?Ontario?Canada \u5600 Benjamin Korman ?NorthwMonesterntreal \u5500 Canada \u5800 SPIN has also received support from the Sclero ? derma Society of Ontario \u5500 Scleroderma Canada \u5500 and Scl\u00E9rodermie University ? Chicago \u5500 Illinois ? Marc Lambert ? Centre Hospitalier R\u00E9gion ? Qu\u00E9bec \u5800 Dr \u5800 Kwakkenbos was supported by a CIHR Banting Post?doc al Universitaire de Lille \u7200 H\u00F4pital Claude Huriez ? Lille ? France \u5600 Datorvidal Fellowship \u5800 Dr\u5800 Thombs was supported by a Fonds de recherche Launay ? Centre Hospitalier R\u00E9gional Universitaire de Lille \u7200 H\u00F4pitaldu Qu\u00E9bec \u7200 Sant\u00E9 \u7E00FRQS \u7F00 researcher salary award ? ClaudeHuriez ?Lille?France ?USA ?PatrickLiang?Univers?it\u00E9dCeoSnhfelirct of interest P Noneof theauthors has financial interest related brooke ? Sherbrooke ? Quebec ? Canada ? Jonathan London ? Assisto this stance tudy to disclose ? Publique H\u00F4pitaux de Paris \u7200 H\u00F4pital Cochin ? Paris ? France ? David Luna ? Instituto Nacional de Ciencias M\u00E9dicas y Nutrici\u00F3n Salvador ?ubir\u00E1n ? Mexico City ? Mexico \u5600 Joanne Manning ? Salford Royal NHS FoundatioRneferences Trust ? Salford ? UK \u5600 Maria Martin ? Servicio de Reumatologia del Hospi\uED03??Seibold J \u5800 Scleroderma \u5800 In P Harris ED \u5500 Budd RC \u5500 Firestein GS \u5500 tal \uED03\uEE00 de Octubre ? Madrid ? Spain ? Thierry Martin ? Les H\u00F4pitaux Uniet?al \u5500 eds \u5800 Kelley ? s textbook of rheumatothloegdy \u5800\u5800 P?hilad?el versitaires de Strasbourg \u7200 Nouvel H\u00F4pital Civil ? Strasbourg ? France ? phia \u5500 PA P Elsevier \uEE03\uEC03\uEC03\uF103\u5600 \uED03\uEE03\uF303\uF503\u7203\uED03\uEF03\uEC03\uF403? Ariel Masetto ? Universit\u00E9 de Sherbrooke ? Sherbrooke \u5500 Quebec ? Can\uEE03a ?? ?igley FM \u5500 Hummers LK \u5800 Clinical features of systemic sclerosis \u5800 da \u5600 Fran\u00E7ois Maurier ? H\u00F4pitaux Priv\u00E9s de Metz \u7200 H\u00F4pital Belle \u7200Isle ? In P Hochberg MC \u5500 Silman AJ \u5500 Smolen JS \u5500 et al \u5803\u5500 eds ?\u5800 Rheumatol Metz ? France \u5600 Arsene Mekinian ? Assistance Publique H\u00F4pitaux de ogy\u5800 Philadelphia P Mosby \uEE03\uEC03\uEC03\uEF03\u5603\uED03\uF003\uF203\uEF03\u7203\uED03\uF003\uF403\uEC03? Paris \u7200 H\u00F4pitaSlt \u7200Antoine ? Paris ? France \u5600 Sheila Melchor ? Servicio \uEF03?deBD\u5800 Frequency and impact of symptoms experienced by pa ?Bassel M \u5500 Hudson M \u5500 TailleferSS \u5500 Schieir O \u5500 Baron M \u5500 Thombs SPIN, including the present feasibility trial, has been funded by grants from the Canadian Institutes of Health Research (TR3-119192, PJT-148504, PJT-149073) and the Arthritis Society. In addition, SPIN has received institutional contributions from the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada and from McGill University, Montreal, Canada. SPIN has also received support from the Scleroderma Society of Ontario, Scleroderma Canada, and Scl\u00E9rodermie Qu\u00E9bec. Dr. Kwakkenbos was supported by a CIHR Banting Postdoctoral Fellowship. Dr. Thombs was supported by a Fonds de recherche du Qu\u00E9bec - Sant\u00E9 (FRQS) researcher salary award.

Keywords

Feasibility studies
Scleroderma
Systemic
Tele-rehabilitation
Trial protocols

ASJC Scopus subject areas

Immunology and Allergy
Rheumatology
Immunology

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10.5301/jsrd.5000263

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@article{a28a3e7be82d4138a4eef51086646e0d,

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 John Varga and Fox, {Rina S.}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2017.",

year = "2018",

month = feb,

day = "1",

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 - Varga, John

AU - Fox, Rina S.

PY - 2018/2/1

Y1 - 2018/2/1

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

UR - http://www.scopus.com/inward/record.url?scp=85055963245&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85055963245&partnerID=8YFLogxK

U2 - 10.5301/jsrd.5000263

DO - 10.5301/jsrd.5000263

M3 - Article

C2 - 35382119

AN - SCOPUS:85055963245

SN - 2397-1983

VL - 3

SP - 91

EP - 97

JO - Journal of Scleroderma and Related Disorders

JF - Journal of Scleroderma and Related Disorders

IS - 1

ER -

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

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