Feasibility Trial of an Internet-based Exercise Program to Improve Hand Function in Patients With Scleroderma: A Scleroderma Patient-centered Intervention Network (SPIN) Study
Phase: NA
Conditions: Scleroderma, Systemic Sclerosis
Sponsor: Lady Davis Institute

 
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PROTOCOL TITLE: 
Randomized Feasibility Trial of the Scleroderma Patient-centered Intervention 
Network Hand Exercise Program (SPIN-HAND): Study Protocol 
 
Clinicaltrials.gov ID: NCT03092024 
Document Date: September 12, 2017 
Published: October 16, 2017 
https://doi.org/10.5301/jsrd.5000263 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Randomized Feasibility Trial of the Scleroderma Patient-centered Intervention 
Network Hand Exercise Program (SPIN-HAND): Study Protocol 
 
Short Title: Protocol for SPIN-HAND Feasibility Trial 
 
Marie-Eve Carrier1; Linda Kwakkenbos1-3; Isabelle Boutron4,5; Joep Welling6; Maureen 
Sauve7,8; Cornelia van den Ende9; Anne A. Schouffoer10; Marie Hudson1,11; Brett D. 
Thombs1,2,11-14; Luc Mouthon4,15; and the SPIN Investigators16 
 
1Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada; 
2Department of Psychiatry, McGill University, Montreal, Quebec, Canada; 3Behavioural 
Science Institute, Clinical Psychology, Radboud University, Nijmegen, The Netherlands; 
4Université Paris Descartes, Paris, France; 5Assistance Publique-Hôpitaux de Paris, 
Paris, France; 6NVLE Dutch patient organization for systemic autoimmune diseases, 
Utrecht, The Netherlands; 7Scleroderma Society of Ontario, Hamilton, Ontario, Canada; 
8Scleroderma Canada, Ottawa, Ontario, Canada; 9Sint Maartenskliniek, Nijmegen, The 
Netherlands; 10Leiden University Medical Center, Leiden, The Netherlands; 
11Department of Medicine, McGill University, Montréal, Québec, Canada; 12Department 
of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montréal, 
Québec, Canada; 13Department of Psychology, McGill University, Montréal, Québec, 
Canada; 14Department of Educational and Counselling Psychology, McGill University, 
Montréal, Québec, Canada; 15Service de Médecine Interne, Hôpital Cochin, Paris, 
France; 16The SPIN Investigators: Murray Baron, McGill University, Montreal, Quebec, 

 
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Canada; Susan J. Bartlett, Dan Furst, University of California, Los Angeles, California, 
USA; Karen Gottesman, Scleroderma Foundation, Los Angeles, California, USA; McGill 
University, Montreal, Quebec, Canada; Frank van den Hoogen, Radboud University 
Medical Center and Sint Maartenskliniek, Nijmegen, The Netherlands; Vanessa 
Malcarne, San Diego State University, San Diego, California, USA; Maureen D. Mayes, 
University of Texas McGovern School of Medicine, Houston, Texas, USA; Warren R. 
Nielson, St. Joseph’s Health Care, London, Ontario, Canada; Robert Riggs, 
Scleroderma Foundation, Danvers, Massachusetts, USA; Fredrick Wigley, Johns 
Hopkins University School of Medicine, Baltimore, Maryland, USA; Shervin Assassi, 
University of Texas McGovern School of Medicine, Houston, Texas, USA; Angela Costa 
Maia, University of Minho, Braga, Portugal; Ghassan El-Baalbaki, Université du Québec 
à Montréal, Montreal, Quebec, Canada; Carolyn Ells, McGill University, Montreal, 
Quebec, Canada; Kim Fligelstone, Scleroderma Society, London, UK; Catherine 
Fortune, Scleroderma Society of Ontario, Hamilton, Ontario, Canada; Tracy Frech, 
University of Utah, Salt Lake City, Utah, USA; Dominique Godard, Association des 
Sclérodermiques de France, Sorel-Moussel, France; Daphna Harel, New York 
University, New York, New York, USA; Ann Impens, Midwestern University, Downers 
Grove, Illinois, USA; Yeona Jang, McGill University, Montreal, Quebec, Canada; Sindhu 
R. Johnson, Toronto Scleroderma Program, Mount Sinai Hospital, Toronto Western 
Hospital, and University of Toronto, Toronto, Ontario, Canada; Ann Tyrell Kennedy, 
Federation of European Scleroderma Associations, Dublin, Ireland; Annett Körner, 
McGill University, Montreal, Quebec, Canada; Maggie Larche, McMaster University, 
Hamilton, Ontario, Canada; Catarina Leite, University of Minho, Braga, Portugal; Carlo 

 
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Marra, Memorial University, St. John’s, Newfoundland, Canada; Karen Nielsen, 
Scleroderma Society of Ontario, Hamilton, Ontario, Canada; Janet Pope, University of 
Western Ontario, London, Ontario, Canada; Alexandra Portales, Asociación Española 
de Esclerodermia, Madrid, Spain; Tatiana Sofia Rodriguez Reyna, Instituto Nacional de 
Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Russell J. Steele, 
Jewish General Hospital and McGill University, Montreal, Quebec, Canada; Maria E. 
Suarez-Almazor, University of Texas MD Anderson Cancer Center, Houston, Texas, 
USA; Durhane Wong-Rieger, Canadian Organization for Rare Disorders, Toronto, 
Ontario, Canada; Christian Agard, Centre Hospitalier Universitaire - Hôtel-Dieu de 
Nantes, Nantes, France; Alexandra Albert, Université Laval, Quebec, Quebec, Canada; 
Marc André, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, 
France; Guylaine Arsenault, Université de Sherbrooke , Sherbrooke, Quebec, Canada; 
Nouria Benmostefa, Assistance Publique Hôpitaux de Paris - Hôpital Cochin, Paris, 
France; Ilham Benzida, Assistance Publique Hôpitaux de Paris - Hôpital St-Louis, Paris, 
France; Sabine Berthier, Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, 
France; Lyne Bissonnette, Université de Sherbrooke , Sherbrooke, Quebec, Canada; 
Gilles Boire, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Alessandra 
Bruns, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Patricia Carreira, 
Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain; Marion 
Casadevall, Assistance Publique Hôpitaux de Paris - Hôpital Cochin, Paris, France; 
Benjamin Chaigne, Assistance Publique Hôpitaux de Paris - Hôpital Cochin, Paris, 
France; Lorinda Chung, Stanford University, Stanford, California, USA; Pascal Cohen, 
Assistance Publique Hôpitaux de Paris - Hôpital Cochin, Paris, France; Pierre 

 
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Dagenais, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Christopher 
Denton, Royal Free London Hospital, London, UK; Robyn Domsic, University of 
Pittsburgh, Pittsburgh, Pennsylvania, USA; James V. Dunne, St. Paul's Hospital and 
University of British Columbia, Vancouver, British Columbia, Canada; Regina Fare, 
Servicio de Reumatologia del Hospital 12 de Octubre, Madrid, Spain; Dominique Farge-
Bancel, Assistance Publique Hôpitaux de Paris - Hôpital St-Louis, Paris, France; Paul 
R. Fortin, CHU de Québec - Université Laval, Quebec, Quebec, Canada; Anna Gill, 
Royal Free London Hospital, London, UK; Jessica Gordon, Hospital for Special Surgery, 
New York City, New York, USA; Brigitte Granel-Rey, Aix Marseille Université, and 
Assistance Publique Hôpitaux de Marseille - Hôpital Nord, Marseille, France; Claire 
Grange, Centre Hospitalier Lyon Sud, Lyon, France; Genevieve Gyger, Jewish General 
Hospital and McGill University, Montreal, Quebec, Canada; Eric Hachulla, Centre 
Hospitalier Régional Universitaire de Lille -Hôpital Claude Huriez, Lille, France; Pierre-
Yves Hatron, Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez, 
Lille, France; Ariane L Herrick, University of Manchester, Salford Royal NHS Foundation 
Trust, Manchester, UK; Adrian Hij, Assistance Publique Hôpitaux de Paris - Hôpital St-
Louis, Paris, France; Monique Hinchcliff, Northwestern University, Chicago, Illinois, 
USA; Alena Ikic, Université Laval, Quebec, Quebec, Canada; Niall Jones, University of 
Alberta, Edmonton, Alberta, Canada; Artur Jose de B. Fernandes, Université de 
Sherbrooke, Sherbrooke, Quebec, Canada; Suzanne Kafaja, University of California, 
Los Angeles, California, USA; Nader Khalidi, McMaster University, Hamilton, Ontario, 
Canada; Benjamin Korman, Northwestern University, Chicago, Illinois, Marc Lambert, 
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez, Lille, France; 

 
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David Launay, Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude 
Huriez, Lille, France; USA; Patrick Liang, Université de Sherbrooke, Sherbrooke, 
Quebec, Canada; Jonathan London, Assistance Publique Hôpitaux de Paris - Hôpital 
Cochin, Paris, France; David Luna, Instituto Nacional de Ciencias Médicas y Nutrición 
Salvador Zubirán, Mexico City, Mexico; Joanne Manning, Salford Royal NHS 
Foundation Trust, Salford, UK; Maria Martin, Servicio de Reumatologia del Hospital 12 
de Octubre, Madrid, Spain; Thierry Martin, Les Hôpitaux Universitaires de Strasbourg - 
Nouvel Hôpital Civil, Strasbourg, France; Ariel Masetto, Université de Sherbrooke, 
Sherbrooke, Quebec, Canada; François Maurier, Hôpitaux Privés de Metz - Hôpital 
Belle-Isle, Metz, France; Arsene Mekinian, Assistance Publique Hôpitaux de Paris - 
Hôpital St-Antoine, Paris, France; Sheila Melchor, Servicio de Reumatologia del 
Hospital 12 de Octubre, Madrid, Spain; Romain Paule, Assistance Publique Hôpitaux de 
Paris - Hôpital Cochin, Paris, France; Alexis Régent, Assistance Publique Hôpitaux de 
Paris - Hôpital Cochin, Paris, France; Sébastien Rivière, Assistance Publique Hôpitaux 
de Paris - Hôpital St-Antoine, Paris, France; David Robinson, University of Manitoba, 
Winnipeg, Manitoba, Canada; Esther Rodriguez, Servicio de Reumatologia del Hospital 
12 de Octubre, Madrid, Spain; Sophie Roux, Université de Sherbrooke, Sherbrooke, 
Quebec, Canada; Perrine Smets, Centre Hospitalier Universitaire Gabriel-Montpied, 
Clermont-Ferrand, France; Doug Smith, University of Ottawa, Ottawa, Ontario, Canada; 
Vincent Sobanski, Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude 
Huriez, Lille, France; Robert Spiera, Hospital for Special Surgery, New York, New York, 
USA; Virginia Steen, Georgetown University, Washington, DC, USA; Evelyn Sutton, 
Dalhousie University, Halifax, Nova Scotia, Canada; Benjamin Terrier, Assistance 

 
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Publique Hôpitaux de Paris - Hôpital Cochin, Paris, France; Carter Thorne, Southlake 
Regional Health Centre, Newmarket, Ontario, Canada; John Varga, Northwestern 
University, Chicago, Illinois, USA; Pearce Wilcox, St. Paul's Hospital and University of 
British Columbia, Vancouver, British Columbia, Canada; Julie Cumin, Jewish General 
Hospital, Montreal, Quebec, Canada; Rina S. Fox, San Diego State University and 
University of California, San Diego, San Diego, California, USA; Shadi Gholizadeh, San 
Diego State University and University of California, San Diego, San Diego, California, 
USA; Lisa R. Jewett, Jewish General Hospital and McGill University, Montréal, Québec, 
Canada; Brooke Levis, Jewish General Hospital and McGill University, Montreal, 
Quebec, Canada; Sarah D. Mills, San Diego State University and University of 
California, San Diego, San Diego, California, USA; Mia R. Pepin, Jewish General 
Hospital, Montreal, Quebec, Canada; Kimberly Turner, Jewish General Hospital, 
Montreal, Quebec, Canada. 
 
Address for Correspondence: Brett D. Thombs, PhD; Jewish General Hospital; 4333 
Côte-Sainte-Catherine Road; Montreal, Quebec, Canada; H3T 1E4; Telephone: (514) 
340-8222 ext. 25112; Fax: (514) 340-8124; Email: brett.thombs@mcgill.ca. 
 
Trial Registration: NCT03092024 
 
Word Count: 2,963 
 
 
 

 
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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. 

 
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Funding Source: Canadian Institutes of Health Research and Arthritis Society 
Trial Registration: NCT03092024 
 
KEY WORDS: feasibility studies; scleroderma, systemic; tele-rehabilitation; trial 
protocols 

 
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INTRODUCTION 
Systemic sclerosis (SSc, or scleroderma) is a rare autoimmune disease that 
affects the skin and internal organs including lungs, gastrointestinal tract and 
cardiovascular system.1,2 Patient-reported problems include limitations in physical 
mobility and hand function, pain, fatigue, sleep disturbance, depression, sexual 
dysfunction, and appearance changes.3-6 Despite significant advances in symptom 
management, there is still no disease-modifying agent; thus, a primary goal of care is to 
reduce disability and improve health-related quality of life (HRQL).7  
Psychosocial, educational and rehabilitation interventions can improve disease 
management and function, and these interventions are important components of 
patient-centered care in more common diseases. There are barriers to developing, 
testing and disseminating these interventions in rare diseases,8 and many rare disease 
patients, including people living with SSc, face unique challenges that are not 
addressed by interventions developed for more common conditions.9-12 
The Scleroderma Patient-centered Intervention Network (SPIN) was established 
to address this issue.8 SPIN is a collaboration of clinicians, patients and investigators 
from Canada, the USA, Europe and Latin America (www.spinsclero.com). Over 1900 
SSc patients from over 40 centres have been enrolled in SPIN’s web-based cohort. 
SPIN investigators are developing a series of online interventions to be tested with 
SPIN Cohort participants in pragmatic randomized controlled trials (RCTs). 
The first SPIN intervention to be tested is an online program of hand exercises 
designed to improve hand function (SPIN-HAND). Contractures and deformities of the 
hand, consisting of decreased flexion and limited extension as well as reduced thumb 

 
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abduction, are present in approximately 90% of SSc patients.3,13 Impaired hand function 
is a major contributor to overall disability and reduced HRQL,13,14 and SSc patients rank 
impaired hand function at the top of their list of problems that impact their daily lives.3,13 
Three RCTs have evaluated physical or occupational therapy interventions to 
improve hand function in SSc, but all were limited by small samples (N < 20 per arm) 
and significant methodological shortcomings.15 Additionally, Schouffoer et al.16 reported 
that a 12-week multidisciplinary day treatment program, which included hand exercises, 
improved grip strength and reduced disability compared to usual care 24 weeks post-
randomization (N = 53). Recently, another RCT tested a one-month general SSc home-
based exercise therapy program, which included hand exercises (N = 218).17 The 
program improved hand function significantly at 6-months follow-up, but gains were no 
longer statistically significant at 12-months post-randomization. Possible reasons why 
the impact of the intervention on hand function was not greater and longer lasting 
include that it was a general exercise program that did not focus specifically on hand 
function and that the one-month program did not provide resources to support ongoing 
patient adherence. In post-trial interviews, patients encouraged the development of an 
internet-based tool to increase ongoing adherence and motivation (manuscript under 
review). 
Prior to a full-scale RCT, a feasibility trial of SPIN-HAND will be conducted to 
ensure the feasibility of the planned trial methodology and that the online intervention is 
user-friendly and acceptable to trial participants.18-21 Feasibility study outcomes will 
inform and guide adjustments to the online intervention and the trial protocol that might 

 
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need to be implemented before undertaking the full-scale SPIN-HAND RCT to assess 
effectiveness.  
The aim of the proposed feasibility trial is to evaluate the feasibility of conducting 
a full-scale RCT of the SPIN-HAND intervention by obtaining data related to the study’s 
process, required resources and management, scientific aspects, and participant 
acceptability. The SPIN-HAND feasibility study is not meant for hypothesis testing or 
effect size estimation, as the sample size is not appropriate to do so. 
METHODS 
Design and setting 
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 (cmRCT) design. In the cmRCT design,22 participants enrol in an 
observational cohort with regular outcome measurement. Participants consent to allow 
their data to be used for observational studies. They consent to allow their data to be 
used to assess intervention trial eligibility and, if eligible, to be randomized to the 
intervention or control arm of the trial. They also consent that if they are eligible and 
randomized to the intervention arm, they will be contacted and offered access to the 
intervention; Finally, they consent that if eligible and randomized to usual care, they will 
not be notified that they are involved in the trial usual care group, but their regularly 
collected cohort data will be used to evaluate trial outcomes. Trial eligibility will be 
assessed during regular SPIN Cohort assessments, which occur every 3 months, and 
trial outcomes will be obtained at the subsequent SPIN Cohort assessment 3 months 
later. 

 
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Participants 
To be eligible for the SPIN Cohort, patients must be classified as having SSc 
based on 201323 ACR/EULAR criteria confirmed by a SPIN physician, be ≥18 years old, 
be able to give informed consent, be fluent in English, French or Spanish, and be able 
to respond to questionnaires via the internet. Since this is a pragmatic trial that intends 
to determine if providing the SPIN-HAND Program, in addition to usual care, improves 
hand outcomes, patients will not be excluded if they are engaged in hand exercises as 
part of their usual care. The SPIN Cohort is a convenience sample. Eligible SPIN 
Cohort patients are recruited at SPIN sites (www.spinsclero.com/en/sites) during regular 
medical visits, and written informed consent is obtained. A medical data form is 
submitted online by the site to enrol participants. Cohort participants complete outcome 
measures via the internet upon enrolment and subsequently every 3 months.8  
For the SPIN-HAND feasibility trial, 40 English-speaking SPIN Cohort 
participants will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND 
program or usual care, defined as the standard care that they receive from their regular 
healthcare providers. Cohort participants will be eligible for the feasibility trial if they 
complete their SPIN Cohort measures in English, have at least mild hand function 
limitations (Cochin Hand Function Scale24 (CHFS) ≥ 3), and have indicated high interest 
in using an online hand exercise intervention (≥7 on 0-10 scale). Assessment of hand 
function limitations and interest will occur as part of participants’ regular SPIN Cohort 
assessments. 
Procedure: randomization, allocation concealment, consent and blinding 

 
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Randomization to be offered versus not offered the SPIN-HAND intervention will 
occur at the time of Cohort participants’ regular SPIN Cohort assessments. Eligible 
Cohort participants, based on questionnaire responses, will be randomized 
automatically as they complete their regular SPIN Cohort assessments using a feature 
in the SPIN Cohort platform, which provides immediate centralized randomization and, 
thus, complete allocation sequence concealment. Participants randomized to be offered 
the intervention will receive an automated email invitation including a link to the SPIN-
HAND program site and the SPIN-HAND feasibility study consent form. At initial login, 
they will be prompted to provide written consent to participate in the SPIN-HAND 
feasibility study by verifying agreement with consent elements and providing their email 
address as the signature. Participants who consent will be automatically re-directed to 
the introduction page of the SPIN-HAND program. Patients who log out before agreeing 
to the terms of the consent form will return to the consent page upon subsequent logins. 
SPIN personnel will also contact participants by phone, usually within 48 hours of 
sending the invitation email, to describe the study, review the consent form, and answer 
questions. Participants who accept the offer to use the SPIN-HAND intervention can 
use the web link to enter the secure intervention site. Email and phone technical support 
will be available to help participants with the consent process and to access and use the 
intervention site. See figure 1 for SPIN Cohort participants flow through the SPIN-HAND 
feasibility trial.  
In pragmatic trials, participants are typically not blinded to intervention status and 
possible biases are accepted as part of the response to being offered an intervention, 
as may occur in practice.25,26 Disappointment bias, however, can occur in conventional 

 
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trial designs when a participant enrolls in a trial to receive an intervention, but is 
allocated to usual care.22,25 For this reason, in the cmRCT design,22 participants who 
are not offered an intervention are not notified that they have not been offered the 
intervention. This replicates actual practice, where patients are not typically advised 
about treatments that are not options, and reduces risk of disappointment bias.22,26,27 All 
participants in the SPIN Cohort are aware that SPIN will conduct intervention trials and 
are routinely asked about potential interest in 9 possible interventions, but are not 
informed that any particular intervention may be available unless they are offered to try 
the intervention. Thus, participants who are offered the intervention are not blind to their 
status, whereas participants assigned to usual care are blind to their participation in the 
trial and trial arm. 
Intervention 
Home-based exercise rehabilitation programs have been shown to improve hand 
function in SSc17 and rheumatoid arthritis.28,29 SPIN’s hand exercise program is based 
on these programs and integrates key components of successful disease self-
management programs, including goal-setting and feedback, social modeling, and 
mastery experiences.30-33 The SPIN-HAND exercise program was designed by SPIN 
experts in physical medicine, rehabilitation, physical and occupational therapy, and 
behavioural therapies, together with patient representatives. The core of the program 
consists of 4 modules that address specific aspects of hand function, including (1) 
Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) 
Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). 
Participants can select the modules in the order that they prefer, based on a description 

 
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of the type of function that the module is targeting to maintain or improve. The program 
includes sections on developing a personalized program, goal-setting strategies and 
examples, progress tracking, sharing goals and progress with friends and family, and 
patient stories of experiences with hand disability and hand exercises. The program 
utilizes an engaging and easy to navigate web interface. Instructional videos with SSc 
patients demonstrate and explain how to perform each exercise properly, and additional 
pictures illustrate common mistakes. Separate versions of each exercise are available 
for participants with mild to moderate and more severe hand involvement. In the SPIN-
HAND program, participants can identify their level by reviewing photos of hands of 
patients with mild to moderate versus more severe involvement. Some exercise videos 
include pictures to illustrate alternate versions on how to perform the exercise when 
there is very severe hand involvement. Participants are provided guidance on selecting 
intervention intensity levels. For the first 4 weeks of the program, it is suggested that 
they focus on exercises in one module per week and are encouraged to do the 
exercises 3-5 times per week. Time per day graduates from 3-4 minutes in week 1 to 5-
15 minutes in week 4. Starting with week 5, participants are asked to select from a 
menu of program options to fit their needs and schedule. Options range from 5-10 
minutes per day to 30-35 minutes per day. Participants offered the program will be able 
to access it for the entire 3-month trial period. 
Outcomes and measurement 
The primary aim of the SPIN-HAND feasibility study is to collect data related to 
the study’s process to assess the feasibility of the steps that need to take place as part 
of the main study; required resources and management (e.g., personnel and data 

 
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management issues); scientific aspects (e.g., outcome assessments), and participant 
acceptability (e.g., ease of use). Data will be used to determine whether it is feasible to 
carry on the main study or whether changes need to be made before undertaking a full-
scale RCT. The feasibility trial outcomes related to the process and resources will be 
assessed throughout the duration of the feasibility trial, and participant feedback will be 
obtained 3 months post-randomization. 
Outcomes and Measures 
Process and resources 
Information to be collected includes: (1) the proportion of SPIN Cohort 
participants who meet eligibility criteria; (2) proper functioning of automated eligibility 
and randomization procedures; (3) the proportion of eligible participants randomized to 
be offered the SPIN-HAND intervention who accept the offer and consent to participate; 
(4) completeness of online data collection for each trial arm at 3-month follow-up; (5) 
completeness of the intervention usage log data; (6) ability to successfully link data 
coming from the SPIN Cohort and SPIN-HAND platforms; (7) rate of completion of trial 
outcome variables; (8) personnel requirements to call enrolled participants and help 
them to consent and use the SPIN-HAND program; (9) other challenges for study 
personnel; and (10) technological performance of the online SPIN-HAND program.  
Participant Use and Acceptability of SPIN-HAND Intervention, Implementation of Trial 
Procedures 
Usage of the SPIN-HAND program modules among participants in the 
intervention arm will be examined via intervention usage data. These data will provide 
detailed information on number of logins, number of modules accessed, goals set, as 

 
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well as time spent on each webpage. Additionally, at 3-months post-randomization, 
qualitative interviews will be conducted with participants in the intervention arm to 
assess user acceptability and satisfaction. The semi-structured interview will be guided 
by items of the Patient Education Materials Assessment Tool for Audiovisual Materials34 
and will address topics related to usability, understandability, organization, and clarity. 
Participant feedback from these interviews will inform any changes necessary to 
improve the SPIN-HAND program prior to conducting a full-scale RCT. See Appendix A.  
Trial personnel time requirements will be logged, and trial personnel will be 
interviewed to understand any implementation challenges. 
Trial Measures 
The objectives of the full-scale SPIN-HAND RCT will be to evaluate the effect of 
being offered access to SPIN’s online hand exercise program, compared to usual care 
alone, on hand function (primary), functional health outcomes, and HRQL. In both the 
present feasibility study and the full-scale RCT, outcome measures are routinely 
assessed as part of the SPIN Cohort assessments every 3-months. Thus, no additional 
assessments will be added for the trial that are not already done as part of the SPIN 
Cohort. 
The 18-item Cochin Hand Function Scale (CHFS)24 was developed to measure hand 
function limitations among patients with rheumatic diseases. The CHFS assesses ability 
to perform hand-related activities (e.g., kitchen, dressing oneself, hygiene, 
writing/typing). Items are scored on a 0-5 Likert scale (0=without difficulty; 
5=impossible). Higher scores indicate less functionality. The total score is obtained by 
adding the scores of all items (range 0-90). The CHFS has good convergent validity 

 
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with general functional disability measures and good sensitivity to change.14,24,35,36 It has 
been validated in SSc.36  
Patient-reported health status will be measured using the 29-item Patient Reported 
Outcomes Measurement Information System (PROMIS-29) profile version 2.0. The 
PROMIS-29 measures 7 domains of health status with 4 items each (physical function, 
anxiety, depression, fatigue, sleep disturbance, social roles and activities, pain 
interference) plus a single item for pain intensity. Domain items are scored on a 5-point 
scale (range 1-5), with different response options for different domains, whereas the 
single pain intensity item is measured on an 11-point rating scale. Higher scores 
represent more of the domain being measured; that is, better physical function and 
ability to participate in social roles and activities, but higher levels of anxiety, 
depression, fatigue, sleep disturbance, pain interference, and pain intensity. Total raw 
scores are obtained by summing item scores for each domain, which are converted into 
T-scores standardized from the general US population (mean=50, SD=10). PROMIS-29 
version 2.0 has been validated in SSc.37,38 
HRQL will be assessed with the EQ-5D,39 a 5-item standardized questionnaire, 
measuring 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression). The items are rated from 1 (no problems) to 3 (extreme problems). 
Sample size 
Guidance on the appropriate sample size for feasibility trials varies substantially 
in the published literature, with rules-of-thumb varying from n=12 to n=30 or more per 
trial arm.40,41 To ensure that we collect sufficient quantitative and qualitative outcome 
data to meet our feasibility objectives and guide the next study phase, we will include a 

 
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total of 40 SPIN Cohort participants in this feasibility trial (approximately 20 per trial 
arm). 
Data collection, storage and sharing 
Outcome measures are completed through the participants’ regular SPIN Cohort 
assessments. The SPIN Cohort uses a secure electronic data management platform 
designed and managed by the Information Management Services (IMS) of the Centre 
for Clinical Epidemiology, Jewish General Hospital, Montreal. Separate from the SPIN 
Cohort portal, an encrypted database has been created for the SPIN-HAND program, 
which include an identification number for intervention participants to link to SPIN 
Cohort data and their usage log information. 
Data Analysis 
The primary data analysis will present a description of feasibility outcomes, 
including participants’ eligibility and recruitment and numbers and percentages of 
participants who respond to follow-up measures. Use of the internet intervention will be 
described by presenting the frequency of logins and time spent on the SPIN-HAND 
program. Analysis of outcome measures will include the completeness of data and 
presence of floor or ceiling effects. Descriptive statistics will be used to provide means 
and standard deviations for the measures. Qualitative information on participants’ 
experience using the SPIN-HAND intervention will be used to interpret acceptability 
related to content, webpage visuals, and navigation. Information related to required 
resources and management of the program during feasibility will inform any necessary 
changes to intervention or trial procedures. 
Adverse events 

 
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The risk of adverse events occurring as a consequence of the SPIN-HAND 
program is very low. All hand exercises recommended are explained in detail with an 
emphasis on choosing a level that is comfortable for the study participant. Nonetheless, 
adverse events will be assessed via interview and open-ended question. Any events 
reported will be discussed with clinical members of the team and referrals to local SPIN 
physicians will be made as necessary. Any serious adverse events that occur will also 
be reported to the ethics committee. 
Ethics and trial registration 
Ethics approval for the SPIN-HAND feasibility trial has been obtained from the 
Research Ethics Committee of the Jewish General Hospital, Montreal, Canada. The 
SPIN-HAND feasibility study was registered prior to participant enrolment 
(NCT03092024) and will be reported in accordance with standards articulated in the 
Consolidated Standards of Reporting Trials (CONSORT) extensions for randomised 
pilot and feasibility trials.21 
Discussion  
The SPIN-HAND exercise program may improve hand function in SSc patients. 
This feasibility study will ensure that trial methodology is robust, feasible, and consistent 
with participant expectations.18-21 Results will guide any changes that need to be 
implemented before conducting a full-scale RCT to test the effectiveness of the SPIN-
HAND intervention. Based on current SPIN Cohort data, we anticipate that 45-50% of 
Cohort patients will be eligible for the full-scale SPIN-HAND trial. Thus, we anticipate 
being able to easily meet recruitment goals for that trial, and patients who are included 
in the intervention arm of the feasibility trial will not be eligible for the subsequent full-

 
22 
scale trial. If effective, it will be made available through patient organizations around the 
world to support people in their efforts to cope with living with SSc.  
 
 

 
23 
Acknowledgements 
The SPIN team is dedicating the SPIN-HAND program to the memory of Dr. 
Serge Poiraudeau, who led the SPIN-HAND project team, along with Dr. Luc Mouthon. 
Dr. Poiraudeau cared deeply for the quality of life and well-being of people living with 
scleroderma, and without his leadership and dedication the SPIN-HAND program would 
not have been possible.  
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 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 Sclérodermie 
Québec. Dr. Kwakkenbos was supported by a CIHR Banting Postdoctoral Fellowship. 
Dr. Thombs was supported by a Fonds de recherche du Québec - Santé (FRQS) 
researcher salary award. 
 
 

 
24 
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40. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 
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30 
Figure 1 Legend. SPIN Cohort and Feasibility Trial Flow (numbers of SPIN Cohort 
patients as of July 24, 2017) 

 
31 
APPENDIX A 
 
SPIN-HAND INTERVENTION PATIENT INTERVIEWS 
 
Did you use a computer or tablet or both to access the SPIN-HAND Program? 
 
Can you please tell us about your experience with the SPIN-HAND Program, including things that you 
liked about the program and things that could be improved? 
 
PROCESS 
 
1. Did the initial invitation email provide you with the information you needed to understand how to sign up 
for the study? 
Yes. No.  
If No: What information was missing? 
   
2. Did you find the follow up telephone call you received within 48 hours of the invitation email to be 
helpful?  
Yes. No.  
If No: Why not?  
 
PURPOSE 
 
3. Did you understand the objective of the SPIN-HAND program? 
Yes. No.  
If No: How could the objective be clarified? 
 
4. Did you find the information provided in the SPIN-HAND program relevant? 
Yes. No.  
If No: How could the information provided be made more relevant for you or other scleroderma patients? 
WORDS AND LANGUAGE 
 
5. Did you find that the intervention used common, everyday language that was easy to understand? 
Yes. No. 
If No: Can you give an example of something or some word(s) that you did not understand? 
 
6. Did you understand all the medical terms or, if not, were they clearly explained in the SPIN-HAND 
program? 
Yes. No. 
If No: Can you give an example of medical term(s) that you did not understand? 
 
CONTENT, ORGANIZATION, NAVIGATION 
 
7. Did you find that the SPIN-HAND program is broken down into manageable chunks or sections? 
Yes. No.  
If No: Which parts of the content weren’t broken down into manageable chunks or sections and how could 
we improve them? 
 
8. Did you find the different pages or sections of the program to be clearly indicated? 
Yes. No.  
If No: What section(s) could be more clearly labeled? 
 
9. Did you find it easy to navigate through the intervention and to understand where to go next?  
Yes. No.  
If No: How could the different steps to navigate the intervention be more clearly explained? 

 
32 
10. Did you consult the “More info” tab (Scleroderma and your hands, FAQ, Patient stories)? 
Yes. No.  
If No: Why not? 
 
11. Did you experience any technical difficulties while using the intervention? 
Yes. No.  
If Yes: What type of technical problems? Did you request assistance from the SPIN team? If you did, was 
the SPIN team able to help you resolve them?  
 
12. Did you use the website tour? 
Yes. No. 
If Yes: Was it helpful to learn to navigate the website? Why or why not? 
 
13. Did you use the “My bookmarks” feature? 
Yes. No. 
If Yes: Did you find it helpful for easily navigating to the pages you wanted? Why or why not?   
 
VISUAL AIDS 
 
14. Did the fact that the intervention was introduced by scleroderma experts and patients make the 
program more relatable? 
Why or why not? 
15. Did you understand how to correctly perform the exercises from watching the videos and listening to 
the audio instructions? 
Yes. No.  
If No: What would have helped you better understand how to correctly perform the exercises?  
 
16. Did you take a look at the “Tips to avoid common mistakes” sections? 
Yes. No.  
If Yes: Did the pictures of common mistakes and written instructions help you to avoid performing wrong 
movements? Yes. No.  
If No: Why didn’t you use the section on common mistakes section? 
 
17. Were you able to clearly understand the people speaking in the videos? 
Yes. No.  
If No: Why couldn’t you understand the words in the videos? (e.g. too fast, too soft, mumbling, accent)?; 
Are there any videos in particular that were more difficult to understand than others? If yes, which one(s);  
 
18. Did you look at the video transcripts? 
Yes. No.  
If Yes: Were the video transcripts helpful to you? Why or why not?  
 
ACTIONABILITY (Routine, Goal-setting, motivation) 
 
19. Did you set an exercise routine for yourself? 
Yes. No.  
If Yes: Did you find it easy to set an exercise routine for yourself using the materials in the SPIN-HAND 
program? Yes. No.  
If No: How could the step-by-step approach be improved or better explained? 
 
20. Did you find an exercise routine that fit your ability level and needs? 
Yes. No.  
If No: What made it hard for you to find an exercise routine that fit your ability level and needs? (e.g., 
levels not appropriate, time spent on exercises per day or per week not appropriate, other reason) 
 

 
33 
21. Did you set goals for yourself using the goal setting material? 
Yes. No. 
Why or why not? 
22. Did you incorporate exercises into your planned routine and stick to it?  
Yes. No.  
If No: What were some obstacles you faced when trying to incorporate the exercises into your routine? 
How could the SPIN-HAND program have helped you to overcome these obstacles? 
 
23. Did you use the option to share your goals with friends and family via email? 
Yes. No.  
If Yes: Did the option to share your goals with friends and family via email help you stick to your goals? 
Yes. No.  
If No: What other motivational feature might have been more helpful? 
 
24. Did you set email reminders for yourself? 
Yes. No. 
If Yes: Did having the option set email reminders for yourself help you incorporate the exercises into your 
routine? Yes. No. 
If No: Did you use another type of reminder to do your exercises? 
 
25. Did you use the feature to track your progress? 
Yes. No.  
If Yes: Did having the option to track your progress week after week encourage you to continue 
performing the exercises? Yes. No. 
If No: Why not? Did you use any other way to track your progress? Is so, what did you do? 
 
OVERALL APPRECIATION 
 
26. How user-friendly on a 0-10 scale (0, being the worst and 10 being the best possible score) would you 
rate the SPIN-HAND program? 
 
27. Would you recommend this program to someone with scleroderma? 
Yes. No. 
If no, why? 
 
28. What grade (on a 0-10 scale, 0 being the worst and 10 being the best possible score) would you give 
the program? 
0 (worst) to 10 (best).  
 
29. Is there anything you want to give us feedback about that was not included in this interview?