The Scleroderma Patient-centered Intervention Network (SPIN) - Scleroderma Support Group Leader EDucation (SSLED) Program Feasibility Trial
Phase: NA
Conditions: Scleroderma, Systemic Sclerosis
Sponsor: Lady Davis Institute

SPIN-SSLED Feasibility Trial 
Dr. Brett Thombs, Principal Investigator 
Study Protocol 
 
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February 1, 2018 
 
 
 
PROTOCOL TITLE: 
The Scleroderma Patient-centered Intervention Network (SPIN) - Scleroderma Support group 
Leader EDucation (SSLED) Program Feasibility Trial 
 
NCT03508661 
 
February 1, 2018 
 
 
 

SPIN-SSLED Feasibility Trial 
Dr. Brett Thombs, Principal Investigator 
Study Protocol 
 
2 
February 1, 2018 
PROTOCOL TITLE: 
The Scleroderma Patient-centered Intervention Network (SPIN) - Scleroderma Support group 
Leader EDucation (SSLED) Program Feasibility Trial 
 
1. Overview 
Many people living with a rare disease turn to peer-led support groups to cope with their condition and 
access educational resources.1-5 Systemic sclerosis (SSc), or scleroderma, is a rare autoimmune connective 
tissue disease where peer-led support groups play an important role. 2-4,6,7 There are currently approximately 
200 SSc support groups in Canada and the US, most of which are led by people with SSc.8,9 Many SSc 
patients, however, cannot access support groups. In other cases, support groups are not sustained due to 
factors that include the burden on group leaders living with a serious, unpredictable disease and limited 
group leadership skills of some untrained leaders.3,4,10 Our partners from Scleroderma Canada and the 
Scleroderma Foundation in the US are committed to improving support group accessibility and 
effectiveness. These organizations maintain a list of active support groups, but currently do not provide 
training or other resources to groups or their leaders. To address this gap, our team, including investigators 
and patients from the Scleroderma Patient-centered Intervention Network (SPIN), developed the 
Scleroderma Support group Leader EDucation (SPIN-SSLED) Program, which is designed to improve 
support group leader confidence and self-efficacy, reduce burnout, improve emotional well-being, and 
improve health-related quality of life. 
The proposed study is requesting ethical approval to conduct a feasibility trial of the SPIN-SSLED 
Program. In the planned full-scale randomized controlled trial (RCT) that will follow our feasibility trial, 
we will evaluate whether the SPIN-SSLED Program is effective in improving SSc support group 
leaders’ self-efficacy for carrying out their leader role (primary) and if it reduces burnout, improves 
emotional well-being, and improves health-related quality of life (secondary). Thus, the SPIN-SSLED 
Feasibility Trial answers the following research questions: (1) Is a full-scale SPIN-SSLED RCT 
feasible? (2) Are adaptations needed to the research design for the planned full-scale RCT? (3) Are there 
ways to improve the SPIN-SSLED Program for delivery in the planned full-scale RCT based on input of 
support group leaders who participate in the feasibility trial?  
To answer these questions, the aim of the SPIN-SSLED Feasibility Trial is to collect data related to the 
study’s process, in order to assess the feasibility of the steps that need to take place as part of the main 
study; required resources (e.g., staffing, time, and budget), management issues (e.g., optimizing 
performance of personnel and data systems); and scientific aspects (e.g., recruitment rates of eligible 
leaders, fidelity of intervention delivery, acceptability of intervention to leaders, performance of 
outcome measures). 
2. Background and Rationale 
 
People with rare diseases experience many of the same challenges as those with more common diseases, 
but also face unique challenges, including gaps in knowledge about their disease and limited treatment 
and support options.11-16 Professionally organized support services are often available for people with 
more common diseases,1 but are not typically available for people with rare diseases.11-16 Instead, many 
people with rare diseases rely on peer-led support groups for education and to cope with their disease.1-5 

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Support groups may be held face-to-face or online, led by professionals or peers, and have a structured 
or an unstructured format. Activities typically involve an educational or information-sharing component 
and the exchange of emotional and practical support.1-5 
Systemic sclerosis (SSc), or scleroderma, is a rare, chronic, autoimmune connective tissue disease 
characterized by abnormal fibrotic processes and excessive collagen production.6 Peer-led support 
groups play an important role for people with the disease.2-4,7 There are currently approximately 200 
active SSc support groups listed by Scleroderma Canada or the Scleroderma Foundation in the USA, 
most led by people with the disease.8,9 Many people with SSc, however, do not have access to SSc 
support groups, and many support groups that are initiated are not sustained due to obstacles that could 
be addressed by providing training to support group leaders.3,4 Challenges for patient support group 
leaders, particularly in rare diseases, include practical difficulties, such as a lack of resources or poor 
coordination with medical professionals and leader organizations; difficulties with group leadership 
tasks, such as managing complex group dynamics; and personal challenges, such as managing one’s 
own health condition while supporting others and preventing burnout.17,18 
A training and education program could provide the necessary information and skills to improve the 
ability of SSc peer support group leaders to lead sustainable, effective support groups; reduce their 
emotional and physical burden; and encourage new leaders to set up support groups where none exist or 
via the internet. In rare diseases, face-to-face delivery of such a training program is not feasible because 
current and potential leaders are widely dispersed geographically. Videoconferencing has been used 
successfully to train educators, health service providers, and parents of children with behavioural 
difficulties, for example, and is as effective as face-to-face training.19-22 In SSc, videoconferencing can 
provide a mechanism for creating sufficient scale across provincial and national boundaries to aid in the 
dissemination of support tools where none are available. Most SSc leaders and support group leaders use 
the internet. A 2013 study23 found that 85% of Dutch SSc patients with SSc search the internet for 
information about SSc. SPIN,7 which is led by members of our team, routinely collects data from > 1800 
people with SSc in the SPIN Cohort. 
Scleroderma Canada and the Scleroderma Foundation are committed to developing a shared 
infrastructure to improve support groups effectiveness and accessibility, including the quality of existing 
support groups and increasing the availability of support group services by training new leaders to 
initiate support groups in underserved areas and via the internet. These organizations have partnered 
with our team to develop and test the SPIN-SSLED Program, a 3-month-long group training program 
designed to be delivered via videoconferencing to provide information and skills to improve leader 
support group leaders’ confidence and self-efficacy to carry out their leadership roles and reduce the 
burden on them of leading a support group. If effective, the organizations will adopt the SPIN-SSLED 
Program to provide ongoing training for support group leaders.  
To better understand reasons for attending and not attending support groups and support group leader 
training needs, we conducted one-on-one interviews with 30 support group members, non-attenders, and 
leaders. We then developed a survey, which was completed by 600 North American and 700 European 
and Australian SSc patients (approximately 45% non-attenders, 40% group members, and 15% leaders; 
manuscripts in press4, submitted for review, or in preparation). The proposed SPIN-SSLED Program 
Feasibility Trial builds on this background research and will evaluate the feasibility of delivering the 
SPIN-SSLED Program and of our planned full-scale trial design. We will enroll 10 SSc support group 
leaders and randomly allocate 10 into 2 SPIN-SSLED Program training groups (5 leaders per group). At 

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the end of the feasility trial intervention, we will interview the 10 group leaders who took part in the 
training in order to identify aspects of the program that might be improved. We will use this information 
to make any necessary revisions to the program or our trial methods before conducting a full-scale trial. 
3. Objectives 
(1) To evaluate the feasibility of steps needed to take place in the full-scale trial, including the required 
resources (e.g., staffing, time, and budget), management issues (e.g., related to optimizing performance 
of personnel and data systems), and scientific aspects (e.g., recruitment rates of eligible leaders, fidelity 
of intervention delivery, acceptability of intervention to leaders, assessing performance of outcome 
measures); (2) To make any necessary modifications to the SPIN-SSLED Program based on participant 
feedback. 
 
4. Setting, Sample, and Randomization 
Trial Design: There are no existing training programs for SSc support group leaders. Thus, the planned 
full-scale SPIN-SSLED trial will be a pragmatic RCT that tests whether providing the SSLED Program 
to leaders of SSc support groups will improve outcomes compared to leaders assigned to a wait-list 
control. Pragmatic RCTs differ from explanatory or mechanistic trials in that they are intended to test 
the effectiveness of adding an intervention to routine practice in order to inform practice and policy 
decisions rather than explain intervention mechanisms.24,25,26 SSc support group leaders who are enrolled 
will be randomly allocated to the training program or a wait-list control, and those allocated to training 
will be clustered in training groups where they will interact with each other. We will need to account for 
clustering in the training arm, but not the control arm. Thus, we will use a partially nested RCT trial 
design (PN-RCT).27 The PN-RCT design is a hybrid between a conventional RCT, in which individual 
participants are randomized, and a cluster RCT, in which pre-existing clusters (e.g., primary care 
practices, classrooms) are randomized to intervention or control arms. In the PN-RCT design, analyses 
account for dependence within intervention arm clusters, but treat leaders assigned to the control arm 
individually, as in a conventional RCT. The SPIN-SSLED Feasibility Trial will adhere to this design. 
Participants: To be eligible for the SPIN-SSLED Feasibility Trial leaders must be a current SSc 
support group leader or have been identified by Scleroderma Canada or the Scleroderma Foundation as a 
new leader who will initiate a new support group, must be able to use the internet to access and 
participate in training sessions and to complete study questionnaires online, must be available to 
participate at times when sessions are scheduled and be English-speaking. Individuals who are offered 
participation in the feasibility study will be excluded from the subsequent full-scale RCT. As the 
majority of leaders who are members of the organizations from which we are recruiting are English-
speaking, in order to ensure that there will be an adequate number of French-speaking participants in the 
RCT, only English-speaking leaders will be included in the feasibility study. Therefore, for the proposed 
feasibility study, only English-speaking leaders will be recruited, and the resulting program will be 
subsequently translated into French. The full-scale trial will be conducted in English and French. 
Recruitment, Consent and Randomization: Our partners from the Scleroderma Canada and the 
Scleroderma Foundation will contact group leaders to describe the SPIN-SSLED Feasibility Trial and 
ascertain interest in participating. SPIN-SSLED personnel will send email invitations with the consent 
form to interested support group leaders. Following this, support group leaders will be contacted by 
phone within 48 hours to describe the study, review the consent form, and answer questions assessing 

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eligibility. Eligible patients who verbally accept the offer to enrol in the study will receive an email with 
the consent form for the study, which they can sign by replying, “I have read the consent form and 
understand the terms of the feasibility study. I agree to participate in the study testing the 
feasibility of the SPIN-SSLED Program.” We will enrol 10 English-speaking SSc support group 
leaders who we will randomly assign to 2 SPIN-SSLED Program training groups (5 leaders per group). 
All participants will receive an email invitation including a clickable link to the online survey platform 
Qualtrics where they will be asked to complete study measures. The email will also include the date of 
leaders’ first training session, the topic of the first session and information on how to login to the 
videoconferencing system. Email and phone technical support will be available to help leaders with the 
consent process, when they access Qualtrics to complete study measures, and for training sessions. 
5. Intervention  
The SPIN-SSLED Program was developed by a team of researchers with expertise in SSc, patient 
organization representatives, and a Patient Advisory Board comprised of current SSc support group 
leaders. The program content and design is based on results of our preliminary research on support 
groups in SSc and informed by instructional material for support group leaders we identified via the 
internet and by consultations with support group leaders. The program uses a problem-based learning 
approach. Problem-based learning is a learner-centered approach that integrates theory and practice by 
providing the necessary knowledge and skills, presenting a complex, real-world problem, then working 
to identify an approach to solving the problem.29,30 To implement this, each module, or learning session, 
will introduce a topic and provide an overview of key information. Then, there will be a guided 
discussion among training group participants about possible approaches and solutions. 
The program includes 13 modules that will be delivered live via webinar over the course of the 3-month 
program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the 
leader’s role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; 
(5) successful support group culture; (6) managing support group dynamics I; (7) managing support 
group dynamics II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity 
of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support 
group leader resources. In addition to the live modules, SPIN-SSLED participants will receive a 
workbook that summarizes didactic material that is provided and will be shown filmed vignettes 
demonstrating effective group facilitation techniques and ways to respond to support group issues. 
SPIN-SSLED participants will also have access to an online resource center that includes a range of 
helpful tools for leaders including files of SSc related videos to show at meetings and an online forum 
for leaders to post questions, open only to leaders enrolled in the training program. Based on our 
previous experience with videoconferencing and consistent with previous trials of videoconference 
training, to maximize effective interaction and participation, 5 group leaders will be assigned to each 
training group.31,32 Training sessions will be delivered using the GoToMeetingÒ videoconferencing 
platform, a high-performance platform that has been used successfully for similar applications.33,34 
 
6. Measures 
Participant Demographic and Disease-related Variables: A demographics questionnaire will be 
administered to all participants before the trial. The demographics questionnaire designed for this study 

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includes basic demographic information, such as gender, age and employment status. The questionnaire 
also includes disease-related variables, such as years since scleroderma diagnosis. 
SPIN-SSLED Feasibility Measures: The aim of the SPIN-SSLED Feasibility Trial is to collect data 
related to the study’s process, in order to assess the feasibility of the steps that need to take place as part 
of the full-scale RCT, including required resources and management (e.g., personnel and data 
management issues) and scientific aspects (e.g., acceptability, outcome assessments), as well as to obtain 
feedback on possible ways to improve the training program. Data will be used to determine whether it is 
feasible to carry out a full-scale trial, or whether changes need to be made to the trial design or training 
program. The feasibility trial outcomes related to process and resources will be assessed throughout the 
duration of the feasibility trial, and leader feedback will be obtained upon completion of the program. 
The collected measures of feasibility include: 
• How well the enrolment and randomization procedure work; 
• The percentage of eligible group leaders who consent to participation; 
• Personnel requirements to call enrolled leaders and help them with accessing the SPIN-SSLED 
Program online data collection platform; 
• Challenges for study personnel;  
• Technological performance of the videoconferencing system 
We will also evaluate the degree to which the SPIN-SSLED Program is delivered with a high level of 
fidelity to the program manual. To do this, all SPIN-SSLED sessions will be audited for fidelity by two 
members of the research team. We will use standard methods for evaluating intervention fidelity,35 
including observation of entire sessions for a randomly selected sample of 25% of video-recorded 
sessions. Raters will evaluate adherence to each session’s goals and content. Consistent with best-practice 
recommendations for assessing treatment fidelity,35 this will be done using a checklist coding system based 
on a standardized format and adapted for the specific components of the SPIN-SSLED Program manual. 
Finally, individual interviews will be conducted upon completion of the 13-modules to assess the 
accessibility of the intervention, barriers to participating, and user feedback, as well as to explore 
leaders’ experience of taking part in the intervention. Participants who have completed any of the 13 
modules will be asked to participate in the interviews.  
SPIN-SSLED Program Outcome Measures: In the planned full-scale randomized controlled trial 
(RCT) that will follow our feasibility trial, we will evaluate whether the SPIN-SSLED Program is 
effective in improving SSc support group leaders’ self-efficacy for carrying out their leader role 
(primary) and if it reduces burnout, improves emotional well-being, and improves health-related quality 
of life (secondary). In the SPIN SSLED Feasibility Trial, outcome measures will be evaluated at the 
time of random allocation to a SPIN-SSLED Program training group and after completion of the 
Program (3 months post).  
• The Scleroderma Support Group Leader Self-efficacy Scale (SSGLSS) was developed by our 
research team to measure support group leader self-efficacy for performing leader tasks. Initial 
items were extracted from previous measures developed for leaders of cancer support groups. 36-38 
All items were reviewed by our research team for relevancy and repetitiveness, and edited for 
clarity. Additional items were generated to reflect content important to SSc not included in the 

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initial item set. Items were reviewed iteratively by all members of the research team until a 
consensus was reached. The final 32-item scale is scored on a 1-6 Likert scale (1=strongly 
disagree; 6=strongly agree). 
• Burnout will be assessed with the Oldenburg Burnout Inventory (OLBI).39,40 The OLBI is a 16-
item measure of burnout that assesses levels of exhaustion and disengagement in work 
populations. Items were adapted and reviewed by project investigators for use within the support 
group leader population. Items are scored on a 4-point scale from 1 (strongly disagree) to 4 
(strongly agree) 
• Emotional distress will be assessed with the PHQ-8.41,42 The PHQ-8 items measure depressive 
symptoms over the last 2 weeks on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every 
day) with higher scores indicating more depressive symptoms. The PHQ-8 performs equivalently 
to the PHQ-9,41 which is a valid measure of depressive symptoms in leaders with SSc.42 
• Leader-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 
8 domains of health status with 4 items for each of 7 domains (physical function, anxiety, 
depression, fatigue, sleep disturbance, social roles and activities, pain interference) plus a single 
item for pain intensity. Items are scored on a 5-point scale (range 1-5), with different response 
options for different domains, and 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). The PROMIS-29 version 2.0 
has been validated in SSc.43,44 
Harms/Adverse events: The present study is of minimal risk. We do not anticipate that there will be 
any adverse events from participating in the leader training sessions. 
Sample size: Guidance on appropriate sample size for feasibility trials varies substantially in the 
published literature. Published guidelines45 suggest that approximately 10% of the estimated sample size 
for the full-scale RCT should be included in the feasibility study. We anticipate that we will randomize 
approximately 100 leaders in the full-scale trial. Thus, we will include 10 patients in the feasibility trial. 
Data Analysis and Storage: A description of feasibility outcomes will be presented, including leader 
eligibility and recruitment, leader enrolment and randomization, technological performance of the 
videoconferencing system, and treatment fidelity. Qualitative information will inform any necessary 
changes to the program or trial methods before conducting a full-scale trial. Descriptive statistics will be 
used to provide means and standard deviations for SPIN-SSLED Program outcome measures. 
Outcome measures will be completed using the online surveying tool Qualtrics. Once the online survey 
data is collected, data will be exported to the statistics software program, IBM SPSS. Cleaning of the 
data will occur within SPSS, by the researchers, Dr. Thombs and Mr. Razykov, until a final database, 
containing all survey responses, is created. All information obtained about the participants during this 
study will be treated confidentially within the limits of the law. Only the researchers involved in this 

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project will have access to the survey data. To protect the participants’ privacy, upon inclusion in the 
SPIN-SSLED study, a unique participant identification number will automatically be assigned to each 
participant. An encrypted database will be created for the SPIN-SSLED program, which includes the 
patient identification number. Only requests authorized by the principal investigator (Dr. Brett Thombs) 
will be granted access to this encrypted information. The survey is run through Qualtrics, a company 
whose computer servers are located in the USA. Data security measures in place at Qualtrics are 
described in the Qualtrics security statement (http://www.qualtrics.com/security-statement/). 
Information obtained from the survey will be kept for 10 years on encrypted hard drives by the 
researchers responsible for this study. Access to the data will be limited to the investigators of the study: 
Mr. Razykov, and Drs. Brett Thombs, Marie Hudson, Robert Platt, Ghassan El-Baalbaki, Vanessa 
Malcarne, and Sandra Peláez. 
 
9. Risks and Potential Benefits: 
 
We do not anticipate any safety concerns with the use of the SPIN-SSLED program. Participation in the 
SPIN-SSLED Feasibility Trial will involve weekly online training sessions, completion of online 
measures and participation in a post-program interview. Although it is hypothesized that the SPIN-
SSLED Program will improve leaders’ self-efficacy for performing leader tasks, reduce burnout, 
improve emotional well-being, and health-related quality of life, it cannot be guaranteed that leaders will 
receive any benefits from this study. However, information learned from this research may lead to more 
effective SSc support group leader training programs, which may benefit those living with SSc in the 
future. There will be no financial compensation for leaders who are participating in the SPIN-SSLED 
Feasibility Trial.  
 
 

 
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