Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)

The SPIN Investigators

doi:10.7717/peerj.13471

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)

The SPIN Investigators

Organizational Psychology

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

Purpose. The Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlled trial of the SPIN-HAND program. Materials and Methods. The feasibility trial was embedded in the SPIN cohort and utilized the cohort multiple randomized controlled trial (cmRCT) design. In the cmRCT design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about trials conducted using the cohort. When trials were conducted in the cohort, participants randomized to the intervention were informed and consented to access the intervention. Participants randomized to control were not informed that they have not received an intervention. All participants eligible and randomized to participate in the trial were included in analyses on an intent-to-treat basis. Cohort participants with a Cochin Hand Function Scale score ≥ 3/90 and an interest in using an online hand-exercise intervention were randomized (1:1 ratio) to be offered as usual care plus the SPIN-HAND Program or usual care for 3 months. User satisfaction was assessed with semi-structured interviews. Results. Of the 40 randomized participants, 24 were allocated to SPIN-HAND and 16 to usual care. Of 24 participants randomized to be offered SPIN-HAND, 15 (63%) consented to use the program. Usage of SPIN-HAND content among the 15 participants who consented to use the program was low; only five (33%) logged in more than twice. Participants found the content relevant and easy to understand (satisfaction rating 8.5/10, N = 6). Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly. The required technical support was minimal. Conclusions. Trial methodology functioned as designed, and the SPIN-HAND Program was feasibly delivered; however, the acceptance of the offer and use of program content among accepters were low. Adjustments to information provided to potential participants will be implemented in the full-scale SPIN-HAND trial to attempt to increase offer acceptance.

Original language	English
Article number	e13471
Pages (from-to)	1-32
Number of pages	32
Journal	PeerJ
Volume	10
Issue number	8
Early online date	4 Aug 2022
DOIs	https://doi.org/10.7717/peerj.13471
Publication status	Published - 2022

Bibliographical note

Funding Information:
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 funding for its core activities, including the SPIN Cohort, from the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada, the Jewish General Hospital Foundation, Montreal, Canada, McGill University, Montreal, Canada, the Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, the Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland. Brett D. Thombs was supported by a Tier 1 Canada Research Chair. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Publisher Copyright:
© Copyright 2022 Kwakkenbos et al.

Funding

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 funding for its core activities, including the SPIN Cohort, from the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada, the Jewish General Hospital Foundation, Montreal, Canada, McGill University, Montreal, Canada, the Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, the Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland. Brett D. Thombs was supported by a Tier 1 Canada Research Chair. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Keywords

Cohort multiple RCT
Internet intervention
Keywords Feasibility trial
Occupational therapy
Physical therapy
Scleroderma
Systemic sclerosis
Tele-rehabilitation

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@article{52ee9130866843f38f75568b2afa5664,

title = "Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)",

abstract = "Purpose. The Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlled trial of the SPIN-HAND program. Materials and Methods. The feasibility trial was embedded in the SPIN cohort and utilized the cohort multiple randomized controlled trial (cmRCT) design. In the cmRCT design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about trials conducted using the cohort. When trials were conducted in the cohort, participants randomized to the intervention were informed and consented to access the intervention. Participants randomized to control were not informed that they have not received an intervention. All participants eligible and randomized to participate in the trial were included in analyses on an intent-to-treat basis. Cohort participants with a Cochin Hand Function Scale score ≥ 3/90 and an interest in using an online hand-exercise intervention were randomized (1:1 ratio) to be offered as usual care plus the SPIN-HAND Program or usual care for 3 months. User satisfaction was assessed with semi-structured interviews. Results. Of the 40 randomized participants, 24 were allocated to SPIN-HAND and 16 to usual care. Of 24 participants randomized to be offered SPIN-HAND, 15 (63\%) consented to use the program. Usage of SPIN-HAND content among the 15 participants who consented to use the program was low; only five (33\%) logged in more than twice. Participants found the content relevant and easy to understand (satisfaction rating 8.5/10, N = 6). Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly. The required technical support was minimal. Conclusions. Trial methodology functioned as designed, and the SPIN-HAND Program was feasibly delivered; however, the acceptance of the offer and use of program content among accepters were low. Adjustments to information provided to potential participants will be implemented in the full-scale SPIN-HAND trial to attempt to increase offer acceptance.",

keywords = "Cohort multiple RCT, Internet intervention, Keywords Feasibility trial, Occupational therapy, Physical therapy, Scleroderma, Systemic sclerosis, Tele-rehabilitation",

author = "Linda Kwakkenbos and Carrier, \{Marie Eve\} and Joep Welling and Turner, \{Kimberly A.\} and Julie Cumin and Mia P{\'e}pin and \{van den Ende\}, Cornelia and Schouffoer, \{Anne A.\} and Marie Hudson and \{van Breda\}, Ward and Maureen Sauve and Mayes, \{Maureen D.\} and Malcarne, \{Vanessa L.\} and Nielson, \{Warren R.\} and Christelle Nguyen and Isabelle Boutron and Fran{\c c}ois Rannou and Thombs, \{Brett D.\} and Luc Mouthon and \{The SPIN Investigators\}",

note = "Funding Information: 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 funding for its core activities, including the SPIN Cohort, from the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada, the Jewish General Hospital Foundation, Montreal, Canada, McGill University, Montreal, Canada, the Scleroderma Society of Ontario, Scleroderma Canada, Scl{\'e}rodermie Qu{\'e}bec, Scleroderma Manitoba, Scleroderma Atlantic, the Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland. Brett D. Thombs was supported by a Tier 1 Canada Research Chair. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: {\textcopyright} Copyright 2022 Kwakkenbos et al.",

year = "2022",

doi = "10.7717/peerj.13471",

language = "English",

volume = "10",

pages = "1--32",

journal = "PeerJ",

issn = "2167-8359",

publisher = "PeerJ Inc.",

number = "8",

}

TY - JOUR

T1 - Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)

AU - Kwakkenbos, Linda

AU - Carrier, Marie Eve

AU - Welling, Joep

AU - Turner, Kimberly A.

AU - Cumin, Julie

AU - Pépin, Mia

AU - van den Ende, Cornelia

AU - Schouffoer, Anne A.

AU - Hudson, Marie

AU - van Breda, Ward

AU - Sauve, Maureen

AU - Mayes, Maureen D.

AU - Malcarne, Vanessa L.

AU - Nielson, Warren R.

AU - Nguyen, Christelle

AU - Boutron, Isabelle

AU - Rannou, François

AU - Thombs, Brett D.

AU - Mouthon, Luc

AU - The SPIN Investigators

N1 - Funding Information: 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 funding for its core activities, including the SPIN Cohort, from the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada, the Jewish General Hospital Foundation, Montreal, Canada, McGill University, Montreal, Canada, the Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, the Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland. Brett D. Thombs was supported by a Tier 1 Canada Research Chair. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: © Copyright 2022 Kwakkenbos et al.

PY - 2022

Y1 - 2022

N2 - Purpose. The Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlled trial of the SPIN-HAND program. Materials and Methods. The feasibility trial was embedded in the SPIN cohort and utilized the cohort multiple randomized controlled trial (cmRCT) design. In the cmRCT design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about trials conducted using the cohort. When trials were conducted in the cohort, participants randomized to the intervention were informed and consented to access the intervention. Participants randomized to control were not informed that they have not received an intervention. All participants eligible and randomized to participate in the trial were included in analyses on an intent-to-treat basis. Cohort participants with a Cochin Hand Function Scale score ≥ 3/90 and an interest in using an online hand-exercise intervention were randomized (1:1 ratio) to be offered as usual care plus the SPIN-HAND Program or usual care for 3 months. User satisfaction was assessed with semi-structured interviews. Results. Of the 40 randomized participants, 24 were allocated to SPIN-HAND and 16 to usual care. Of 24 participants randomized to be offered SPIN-HAND, 15 (63%) consented to use the program. Usage of SPIN-HAND content among the 15 participants who consented to use the program was low; only five (33%) logged in more than twice. Participants found the content relevant and easy to understand (satisfaction rating 8.5/10, N = 6). Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly. The required technical support was minimal. Conclusions. Trial methodology functioned as designed, and the SPIN-HAND Program was feasibly delivered; however, the acceptance of the offer and use of program content among accepters were low. Adjustments to information provided to potential participants will be implemented in the full-scale SPIN-HAND trial to attempt to increase offer acceptance.

AB - Purpose. The Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlled trial of the SPIN-HAND program. Materials and Methods. The feasibility trial was embedded in the SPIN cohort and utilized the cohort multiple randomized controlled trial (cmRCT) design. In the cmRCT design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about trials conducted using the cohort. When trials were conducted in the cohort, participants randomized to the intervention were informed and consented to access the intervention. Participants randomized to control were not informed that they have not received an intervention. All participants eligible and randomized to participate in the trial were included in analyses on an intent-to-treat basis. Cohort participants with a Cochin Hand Function Scale score ≥ 3/90 and an interest in using an online hand-exercise intervention were randomized (1:1 ratio) to be offered as usual care plus the SPIN-HAND Program or usual care for 3 months. User satisfaction was assessed with semi-structured interviews. Results. Of the 40 randomized participants, 24 were allocated to SPIN-HAND and 16 to usual care. Of 24 participants randomized to be offered SPIN-HAND, 15 (63%) consented to use the program. Usage of SPIN-HAND content among the 15 participants who consented to use the program was low; only five (33%) logged in more than twice. Participants found the content relevant and easy to understand (satisfaction rating 8.5/10, N = 6). Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly. The required technical support was minimal. Conclusions. Trial methodology functioned as designed, and the SPIN-HAND Program was feasibly delivered; however, the acceptance of the offer and use of program content among accepters were low. Adjustments to information provided to potential participants will be implemented in the full-scale SPIN-HAND trial to attempt to increase offer acceptance.

KW - Cohort multiple RCT

KW - Internet intervention

KW - Keywords Feasibility trial

KW - Occupational therapy

KW - Physical therapy

KW - Scleroderma

KW - Systemic sclerosis

KW - Tele-rehabilitation

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UR - https://www.scopus.com/pages/publications/85135499803#tab=citedBy

U2 - 10.7717/peerj.13471

DO - 10.7717/peerj.13471

M3 - Article

AN - SCOPUS:85135499803

SN - 2167-8359

VL - 10

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EP - 32

JO - PeerJ

JF - PeerJ

IS - 8

M1 - e13471

ER -

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)

Abstract

Bibliographical note

Funding

Keywords

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