Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management
Phase: NA
Conditions: Scleroderma
Sponsor: University of Michigan

Taking charge of systemic sclerosis (NCT02494401) 
Page 1 of 16 
Version 08.20.2015 
0 8 .2 0 .201 5  
Study: Taking Charge of Systemic Sclerosis 
NCT: 02494401 
Document Date: 08/20/2015 

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 2 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
 
 HRPO Template  
1) 
Protocol Title (Version # and/or Version Date) 
Taking charge of systemic sclerosis: Improving patient outcomes through 
selfmanagement (Version date 8/20/2015) 
2) 
IRB Review History 
NA 
3) 
Objectives 
The Specific Aims for the current proposal are: 
1. To engage Patient Partners and Stakeholders to assess whether the current interactive 
Internetbased self-management program (Taking Charge Of Systemic Sclerosis) has the 
information people with systemic scleroderma perceive they need to effectively manage their 
disease. 
2. In a RCT, to assess whether the Internet-based self-management program (revised after Patient 
Partner, Stakeholder, and focus group  input) is superior to the control condition in improving 
overall self-efficacy (primary outcome measure), and self-management knowledge and skills 
and other relevant patient-reported outcome measures (physical function, anxiety, depression, 
fatigue, sleep disturbance, pain interference, satisfaction with social roles, pain, appearance, 
health-related quality of life, quality adjusted life years.) 
4) 
Background 
Because scleroderma is a rare disease (designated as an orphan disease by the Food and Drug 
Administration), patients living outside major metropolitan areas may not have access to health 
care providers with a specialized knowledge of scleroderma. Thus, scleroderma patients feel 
isolated from sources of support and education programs. The only education programs 
specifically focused on scleroderma were developed in Sweden, the United Kingdom, and the 
Netherlands. These 3 programs used traditional group sessions that require patients come to central 
locations, which can be difficult for those with mobility issues or fatigue. Furthermore, there may 
not be enough scleroderma patients in a geographic area to support an education program. Creators 
of the Arthritis Self-Management Program and Chronic Disease Self-Management Program have 
developed Internet versions of their successful programs. However, these existing programs do not 
address the specific needs of scleroderma patients, such as body image changes, skin and ulcer 
management, hand contractures, Raynaud’s phenomenon, and lung and gastrointestinal 
involvement. 
To address the lack of educational programs for scleroderma patients, Drs. Poole and Mendelson, 
with input from patients with systemic scleroderma and scleroderma experts (including coprincipal 

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 3 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
investigator [PI], Dr. Khanna), developed a print format self-management program with an 
exercise DVD. Pilot testing of the print version by people with scleroderma showed improved self-
efficacy for managing pain and verified the content and need for such a program. Participants also 
voted on a name for the program, “Taking Charge Of Systemic Sclerosis (TOSS).” We 
subsequently converted the program to an interactive Internet version. Participants who took part 
in the pilot online version proceeded through the modules at their own pace. They were able to 
download resources, exercise programs, learning activities, and worksheets. Furthermore, an audio 
“voice-over” of the text for each module was done to accommodate low literacy and participants 
who experienced fatigue while reading the computer screen or had problems manipulating the 
keyboard.   
  
We recently published the findings from our successful pilot trial of the Internet version, which 
showed increased self-management knowledge and skills and reduced symptoms of fatigue and 
depression. Furthermore, qualitative data from the Discussion Boards and participant evaluation 
surveys suggest that participants felt the content was important and appropriate, and reaffirmed or 
provided new information; participants also felt that the exercise video was very useful. Our 
qualitative and quantitative data support a critical need for an adequately powered comparative 
effectiveness study to determine whether the Internet-based self- management program results in  
better patient-reported outcomes compared with an authoritative educational book, The 
Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes.   
  
This proposal is for collaborative project with partners (people with scleroderma and stakeholders) 
designed to refine an internet program for patients with scleroderma and to compare the internet 
program to an authoritative educational book.  In HUM00096821, Patient Partners, Stakeholders, 
and scleroderma patients participated in focus groups and collaborated with the investigators to 
evaluate and revise TOSS, the existing self-management program. Individuals with systemic 
sclerosis known to the investigators for their participation or leadership in support groups were 
recruited in Michigan, South Carolina and Southern California. Several focus groups with a total of 
30 participants with SSc were conducted:  2 telephone groups and 4 face-to-face groups.  The 
participants were 63% female, 70% Caucasian, 67% had diffuse systemic sclerosis, the mean age 
was 48.8 years, mean disease duration was 11.4 years, and the mean education level was 15.8 
years.  Each focus group lasted 2.0-2.5 hours in duration.   Dominant themes for additions to the 
current website: format changes and additional pictures,  affect and positive affirmation; disease 
and symptom management;  self-advocacy;  information for use by caregivers, families, coworkers 
and strangers; tracking systems for medical records, tests and symptoms; and information about 
local support groups.    
We will now proceed with comparative effectiveness, using a 16-week RCT, we will recruit 250 
patients who will be randomized to either TOSS or authoritative book for patients, The 
Scleroderma Book: A Guide for Patients and Families.  
  
5) Inclusion and Exclusion Criteria  
Inclusion criteria for :   
  
  

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 4 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
All participants will be residents of the United States, diagnosed with systemic scleroderma, and 18 
years of age; will possess basic computer literacy and have access to a computer with Internet and 
email capabilities; and will have the ability to communicate in English and a willingness to 
complete the study protocol. If participants meet the inclusion criteria and express an interest in 
participating, residence will be verified by asking participants for their mailing addresses in order 
to send the consent forms.   
  
Exclusion criteria:  
 Not having access to or experience using a computer with Internet and email capabilities, 
unwilling to complete the study protocol, and unable to communicate in English.   
  
6) Number of Subjects (Recruitment Target)  
  
The maximum number of participants is 250 participants  
There are 3 sites (UNM,  University Michigan, Medical University of South Carolina) but no 
predetermined number of participants accrued at each site.  
Dr. Poole at UNM will recruit from the Scleroderma Foundation and their chapters, and 
Scleroderma Research Foundation.   
Dr. Khanna at UM will recruit from the UM Scleroderma Database 
Dr. Silver at MUSC will recruit from the MUSC Database.  
  
There is no set number of subjects who need to be screened in order to meet recruitment 
goals.    
Sample size determination:   
Our sample size calculation is based on analysis of pre–post changes in the Chronic Disease 
Self-Efficacy Scale in our preliminary Internet study. Based on preliminary data, we expect 
that the effect size (ES; mean pre–post change/SD) in the intervention group will be 
approximately 0.50 (7.2/14.3; medium effect size as suggested by Cohen), and we anticipate 
a negligible effect size in the control group (ES = 0.10). Assuming an alpha of .05 (2-sided 
test), we will need 100 patients in each group to have 80% power for detecting this 
difference between the intervention and control groups. We assume a conservative attrition 
rate of 25% during the study, so we will need to enroll a sample size of 125 patients in each 
group.  
7) Recruitment Methods  
 Individuals with systemic scleroderma will be recruited from the Scleroderma Foundation 
website and through announcements sent to local chapters of the Scleroderma Foundation, the 
Scleroderma Research Foundation,  and clinics at the University of Michigan and Medical  
University of South Carolina (see below). Dr. Poole has successfully recruited patients from the  
Scleroderma Foundation and chapters for studies on self-management, parenting, and work and 
functional disability. These recruitment efforts have yielded diverse samples of individuals 
from all geographic areas across the United States.   

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 5 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
Drs. Khanna and Schiopu will recruit from his patients at the University of Michigan 
Scleroderma Program and will secure IRB approval from the UM. The Scleroderma Program 
at the Medical University of South Carolina is led by Dr. Rick Silver, who also directs the 
Multidisciplinary Clinical Research Center (MCRC) for the Study of Rheumatic Diseases in 
African Americans, funded by NIAMS. Dr. Silver will recruit from his patients and secure 
IRB approval from the MUSC IRB.   
Dr. Poole at UNM will recruit from the Scleroderma Foundation and their chapters, and 
Scleroderma Research Foundation using flyers and advertisements placed on their websites.  
Recruitment materials (scripts to recruit focus group members and advertisements for the 
RCT) have been attached.   
8) Study Timelines  
  
The duration of participation by individuals will be over a period of 10 months (16 weeks and 
6 month follow-up).  
All study participants should be enrolled by August 31, 2016  
PCORI grant is 3 years in duration so it is estimated that we will compete the study by 
August 31, 2017.  
Focus groups were completed by April 26th, 2015  
RCT and post intervention questionnaires completed by January 31, 
2017        6 month follow up completed by August 31, 2017     All data 
analyzed by July 31, 2017.  
  
9) Study Endpoints  
N/A  
  
10) Research Setting  
The interventions (logging on to the website and viewing the modules OR reading the book) 
will be done in participants’ homes or a site convenient to them since they complete 
these at their convenience.  
11) Study Methods   
This proposal is for collaborative project with partners (people with scleroderma and 
stakeholders) designed to refine an Internet-based self-management program for patients with 
scleroderma and to compare the Internet program to an authoritative educational book. In 
HUM00096821, Patient Partners, Stakeholders, and scleroderma patients participated in focus 
groups and collaborated with the investigators to evaluate and revise TOSS, the existing 
selfmanagement program. During this study, we will conduct a comparative effectiveness 
phase, using a 16-week RCT, we will recruit 250 patients who will be randomized to either 

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 6 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
TOSS or authoritative book for patients, The Scleroderma Book: A Guide for Patients and 
Families  
After signing a voluntary consent form electronically through Qualtrics, participants will be 
invited to complete online pre-intervention questionnaires. The participants will be 
randomized to two groups by Dr. Veronica Berrocal, PhD, a biostatistician, at UM using a 
computer block randomization and a 1:1 ratio. Patients will be assigned to either the Internet 
program or the education book group. Although the assignment to either group is random, to 
make sure that the proportion of patients with depressive symptoms are approximately the 
same in both groups, after every 50 patients recruited, the assignment of patients to each group 
up to that point will be cross-tabulated with respect to depressive symptoms on the PHQ-8. 
Depressed mood was identified by patient partners as a key determinant for coping and 
helplessness and a covariate that can influence the primary outcome measure.   If the 
intervention and control groups are not similar with respect to this variable or other variables 
related to depressed mood, assignments to either group for the next 50 patients will be 
administered randomly while trying to make the distributions of patients characteristics 
assigned to the two groups more similar. For example, if by chance patients with more severe 
symptoms have been allocated to the treatment group, randomization of the next 50 patients 
will be carried out so that patients with less severe symptoms are more likely to be assigned to 
the treatment group. The same verification process would be performed for the next set of 50 
patients, and so forth.  
Patients randomized to the active treatment intervention will be assigned to the Internet 
program. The site will be accessed via secured website. The modules will be presented 1-2 per 
week. The Patient Partners and Drs. Newbill and Poole will post weekly questions regarding 
the modules on the Discussion Board and Drs. Newbill and Poole will moderate the online 
discussion as necessary. Participants will be asked to log on to the Discussion Board at least 
once a week.  
Participants in the control group will receive a copy of The Scleroderma Book: A Guide for 
Patients and Families, by Dr. Maureen Mayes. We chose this book to be the comparator 
because it is the authoritative, educational book most requested and used by patients with 
diagnosis of scleroderma. To date, it is the only credible resource written for patients and 
includes sections on early diagnosis, symptoms, coping with the disease, and resources for 
patients.  
  
Outcome Measures      
Demographics. Demographic information will be collected to describe the sample, including 
age, gender, type of scleroderma (diffuse, limited, overlap disease), length of time since 
disease onset and symptoms, self-rated health, education level, marital status, and ethnicity.  
  
Patient Health Questionnaire-8 (PHQ-8), an 8 item questionnaire, will be used to measure 
depressive symptoms.   

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 7 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
Health Log. While enrolled in the study, participants will keep a log of health-related events, 
such as visits to a physician, days sick, days confined to home, and visits to the emergency 
room. Pop-ups on the website and email reminders to controls will remind participants to keep 
track of health-related events.   
PROMIS Self-Efficacy Scale for Managing Symptoms- is an 8 item questionnaire measures confidence 
in managing symptoms.   
PROMIS Self-Efficacy Scale for Managing Daily Activities is an 8 item self-report scale that 
measures perceived self-efficacy or confidence to perform specific tasks or behaviorsof daily 
living..   
PROMIS Self-efficacy Scale for Managing Medications and Treatments is an 8 item self 
report that measures confidence in understanding and taking medications and treatment.   
  
PROMIS Self-efficacy Scale for Managing Emotions is an 8 item scale that measures 
confidence in handling emotions, stress and feelings and anxiety.  
PROMIS Self-efficacy Scale for Managing Social Interactions is an 8 item scale that measures 
confidence in maintaining social activities and getting support from others.  
The Patient Activation Measure. This self-report questionnaire consists of 13 items and 
assesses confidence in self-management of one’s chronic condition.   
Brief Satisfaction with Appearance Scale (SWAP) is a 6 item scale measuring body image concerns 
and social discomfort with body parts.     
  
PROMIS-29 Profile v2.0 Measure. The PROMIS-29 Profile v2.0 measure contains 29 items, 
which includes 4 items each from physical function, anxiety, depression, fatigue, sleep 
disturbance, pain interference, and satisfaction with social roles domains, and a single item on 
pain intensity. With the exception of physical function, which does not include a time frame, 
all item banks reference the past 7 days. PROMIS 29 provides domain scores, similar to SF36.  
European Quality of Life-5 Dimensions (EQ-5D) and Quality Adjusted Life Years (QALYs). 
The EQ-5D is patient preference measure commonly used in comparative effectiveness 
research. It is a generic health-related quality of life instrument that incorporates 
patientreported outcomes along the domains of mobility, self-care, activity, pain, and anxiety. 
These domains are significantly impacted by scleroderma.47 Using a conversion algorithm, 
patient responses are converted into a health utility measure, ranging from 0.0 (death) to 1.0 
(full or optimal health). Through measuring health utility using the EQ-5D at baseline and at 
the end of the study, QALYs gained over the study period will be determined and compared 
between the study groups.   
Study Procedures  
Participants who are interested and meet the inclusion criteria will be invited to participate 
either in person, via telephone script or email script. Subjects who are invited in person will be 
provided a handout with instructions to review an electronic consent form through Qualtrics.  
Once the signed consent is reviewed, participants will be invited to complete the baseline 

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 8 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
questionnaires using Qualtrics, a password protected website maintained at the University of 
Michigan server which only the research team will have access to.  Participants who complete 
the questionnaires and consent on Qualtrics will be randomized to either an intervention or 
control group using a 1:1 ratio and computer-generated block randomization, and will be 
stratified based on scores on the PHQ-8 to ensure one group is not comprised of participants 
who have more severe depressive symptoms than the other.  
The intervention group will be sent the link to the self-management website. Participants will 
be expected to complete the program in 16 weeks. Because we will be recruiting from clinics 
and the website on regular basis, we will start the intervention participants in groups of 10-12 
to help decrease attrition. In keeping with the spirit of self-paced interventions, once 
participants are entered into the intervention, they will be able to progress at their own pace. 
We will be able to track whether people log in and the time spent on the Internet program. We 
will contact participants personally if we notice inactivity. Drs. Newbill, Poole, and the Patient 
Partners will post questions or discussion points weekly on a Discussion Board to keep interest 
in the program.  
Participants randomized to the control group will be sent Dr. Mayes’ textbook. The control 
group will have 16 weeks to read the book; we will contact participants, either through email 
or by phone, at 4, 8, 12, and 16 weeks to check on the progress with the book.   
At the end of the intervention period, participants in both groups will complete the 
postintervention questionnaires using Qualtrics.  In addition, immediately, post-intervention, 
the participants in the intervention group will also be directed to complete a program 
questionnaire in which they are asked to evaluate the content and presentation of the modules 
and provide other feedback to the investigators. To assess whether improvements in 
selfefficacy and knowledge during the 4-month intervention period are sustained, we will 
administer questionnaires to the patients in both groups at 6 months post-intervention. In 
addition, in keeping with the spirit of patient centeredness, after the 6-month follow-up, the 
control group will be provided access to TOSS, the Internet self-management program. A 
variety of strategies will be used to maintain participant engagement in both groups during the 
intervention, such as phone calls or email contact at 4, 8 and 12 weeks and a small incentive at 
midpoint.   
Direct identifiers (name, address, email address, phone numbers) will be collected and 
maintained to send gift cards, contact participants during intervention, and to contact/remind  
participants to complete questionnaires pre-intervention, post and 6 month follow-up.  The 
links will be kept on a password protected computer in a file separate from the data file.  
No drugs or devices are used in this research.  
Copies of all data collection forms, including questionnaires are attached as appendices.  
Participants in both the intervention and control groups will be sent gift cards at different points in 
time for up to a total of $150.  
• 
Upon completing the baseline questionnaires, participants will receive a gift card for $25.  

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 9 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
• 
At the midpoint period of the intervention, participants will receive a gift card for $25 for 
logging in to the modules and discussion board OR reading the book??  
• 
At the 16 week period, upon participating in the intervention or control group for the 16 weeks 
and completing the questionnaires a second time, participants will receive a gift card for $50.  
• 
At the6 month follow-up, upon completing the questionnaires a final time, participants will 
receive a gift card for $50.   
  
  
12) Data and Specimen Banking  
NA. Data will not be stored to use for future analysis.   
13) Data Management  
The following PHI will be collected: Age, gender, education level, type of scleroderma, 
ethnicity, length of time since disease onset and symptoms, marital status, and employment 
status.       
There will be a link between identifiers and data for the purpose of notifying participants to 
complete the post-intervention questionnaires and the 6-month follow up. The link will be 
stored on a password protected computer at the University of Michigan in a locked office of 
the study team. The link will be kept for the length of the grant, until August 31, 2017 and 
destroyed according to UNM destruction policy.   
The PIs and co-Is including the statistician, Dr. Veronica Berrocal, PhD at UM will have 
access to the data.    
Participants in both the intervention and control group will be sent a link to complete the 
questionnaires using Qualtrics (pre, post and 6 months post intervention).  This password 
protected database will be stored on password protected computer at UM in the locked office 
of the study team.  Responses to the Discussion board questions are stored as part of the 
Selfmanagement internet website which can only be assessed by the participants in the 
Intervention group and the investigators.  There are no identifiers associated with the 
responses on the Discussion board.   
 Data Analysis:  
Qualitative Analysis of Discussion Board Posts:   
Discussion Board posts will be qualitatively analyzed using content analysis to identify the key 
content and establish baseline codes that can serve as a preliminary outline or framework of 
the key points in the data. This process will be followed by immersion and crystallization, 
which is an iterative, contemplative, and reflexive approach to data analysis. The researcher 
(Dr.Newbill) will immerse herself in the data “leading to the emergence of insights and 

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 10 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
interpretations.  She has extensive experience in conducting this type of analysis. The first read 
of the data provides a gestalt of the experience from the participant’s perspective. Successive 
readings and reflection on the data assist in the process of crystallization of insight and 
meaning. At the conclusion of the crystallization process, the investigator will have generated 
a series of thematic statements and the essential components of the stories (subthemes) that 
account for the experiences discussed by the participants.  
  
Analysis of Data From RCT:   
Data will be entered into an Excel database and then transferred to SAS or any other 
appropriate statistical software for analysis. The primary outcome measures (PROMIS 
SelfEfficacy Scale for Managing Symptoms, Patient Activation Measure) and other scales 
(PHQ8,  PROMIS Self-Efficacy Scale for Managing Daily Activities, PROMIS Self-efficacy 
Scale for Managing Medications and Treatments, PROMIS Self-efficacy Scale for Managing 
Emotions, PROMIS Self-efficacy Scale for Managing Social Interactions, Brief Satisfaction 
with Appearance Scale (SWAP), PROMIS-29, and EQ-5D, QALY) will be scored, and pre– 
post differences will be calculated. Descriptive statistics will be computed for demographic 
characteristics and outcome measures, and the distributions of pre–post changes will be 
evaluated for normality. The primary analysis will assess the difference in the changed scores 
between the intervention and control groups. Significant differences in changed scores 
between the 2 groups will be determined using paired t tests if the distributions are 
approximately normal or can be transformed to be approximately normal. If the distributions 
are not normal, then the Wilcoxon signed rank test will be used to test whether the differences 
are significant or not. A multivariate generalized linear model will be fit to the changed scores 
data to determine whether covariates such as education and time since diagnosis had a 
significant effect on the pre–post difference in the 2 groups besides the treatment (that is, 
access to the self-management Internet program).  
  
Additionally, to account for variability among patients due to the site of recruitment, a random 
effect for site will be included in the generalized linear model above. The site-specific random 
effect will allows us to control for the fact that some sites might recruit more patients than 
others.  
  
Eventual missing data will be handled by first determining through exploratory analysis 
whether it is missing at random or not. For this purpose, we will calculate summary statistics 
of the primary outcome measures at baseline for those patients who have completed the study 
(completers) and for those who have not (noncompleters). If there are significant differences 
between the groups, then data is not missing at random. If the data are missing at random, we 
will impute the missing data using a generalized linear mixed model approach within a 
Bayesian framework. In a Bayesian framework, missing data are treated as an additional 
model parameter to be estimated during model fitting. Missing values are estimated through an 
iterative procedure by imputing them multiple times based on the data model and the most 
current estimates of the remaining model parameters. We will determine whether there are 

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 11 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
significant differences in the changed primary outcome measures between the control and 
intervention group using only the completers and using the entire set of patients with imputed 
missing values. This will allow us to evaluate the sensitivity of our results to the data 
imputation mechanism. If the exploratory analysis indicates that the data are not missing at 
random, we will expand our statistical model to include a model for the missing data 
mechanism. In a nutshell, a binary variable indicating whether an observation is missing or not 
will be created, and the complete data model will include the multivariate generalized linear 
model described above and a logistic regression model linking the probability that an 
observation is missing in some variables we believe are important in explaining the likelihood 
of a missing observation (for example, demographic characteristics, severity of the disease, 
etc.).  
Analysis of EQ-5D and QALYs. EQ-5D measures will be collected at baseline and at the end 
of the study. EQ-5D responses will be compared between study groups within each domain 
(mobility, self-care, activity, pain, and anxiety). EQ-5D results will also be converted into 
health utility values using the US conversion algorithms. The change in health utility scores 
will be multiplied by the portion of a year elapsed during the study (16 weeks/52 weeks = 
0.308) to determine QALYs gained during the study. Mean values of QALYs gained will be 
compared between study groups to determine the impact of the intervention on QALYs.   
  
Program Evaluation  
Program evaluation will focus on the participants’ perceptions of the value and usefulness of 
the self-education program, their suggestions for improvement, and their evaluation of the 
benefits of the support provided to complete the program. Analysis of program evaluation data 
will include computation of descriptive statistics for the variables on the program evaluation 
questionnaire. The time spent on the website intervention activities, including the Discussion 
Board, which was calculated during the logins, will also be tallied.  
This is NOT a VA study.  
14) Provisions to Monitor the Data to Ensure the Safety of Subjects  
There is no data safety monitoring board because there is no pharmaceutical intervention and 
the risks are minimal. The PI’s contact information will be provided on the consent forms 
should participants have any questions or concerns. Dr. Poole will check in with Dr. Newbill, 
who will be monitoring the Discussion Board. Because participants can log into the 
Discussion Board 24/7, it is not possible to monitor the comments in real time. However, 
should Dr. Newbill or Dr. Poole see any disparaging or desperate comments made by any 
participants, the participants will be contacted by telephone or email. Furthermore, 
participants who have not logged in for more than 2 consecutive weeks will be contacted by 
email or telephone.  

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 12 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
15) Withdrawal of Subjects  
If participants withdraw from the research during the intervention phase, we will remove 
access to the website and will not send them the post or follow-up questionnaires.  
Information from the pre-invention questionnaires will be considered for data analysis.   
The investigators have the right to end participation in this study if they determine that 
participants no longer qualify to take part, do not follow study procedures or if it is in their 
best interest or the studies best interest to stop participation.  The investigators may end 
participation if participants in the control group are not responding to phone calls and it does 
not appear that they are reading the book. Investigator may end participation if participants in 
the intervention group are not logging on to the website and viewing the modules or logging 
on to the discussion board (intervention group).  
16) Risks to Subjects  
There is a small risk of loss of confidentiality, to minimize this risk we have adopted strict 
privacy and confidentiality procedures.    There may be risks of stress, emotional distress, and 
inconvenience in having to log into the website, learning more about systemic sclerosis and 
managing symptoms and participating in discussion boards. People may experience some 
emotional upset and loss of privacy as a result of talking about the illness in the Discussion 
Boards but this is probably no greater than the risk of daily living with the disease. Participants 
do not have to share any information that they do not want to or answer any questions that 
they do not want to. Participants can log in the read others comments without having to share 
any of their information.   
17) Potential Benefits to Subjects  
There may or may not be direct benefit from being in this study.  However, participation by 
participants in both phases may help participants find out ways people with scleroderma manage the 
disease that may or may not be useful. Participation may help develop and refine information included 
in the website on self-management for systemic sclerosis.  
  
18) Vulnerable Populations  
No vulnerable populations are included.  
  
19) Multi-Site Research  
There are 3 sites participating in this study, University of Michigan and the Medical University 
of South Carolina and the University of New Mexico.  They will be recruiting participants 
only from their own patient databases and will obtain their own IRB approval and approval for 
the electronic consent used by Qualtrics. University of Michigan will be the data coordinating 
center. Each site will obtain approval from their respective IRB, using the electronic consent, 
and HIPAA documentation.  Any modifications will be approved by all 3 IRBs before 
modifications are implemented.  Any non-compliance with the protocol or applicable 

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 13 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
requirements will be reported in accordance with local policy and communicated with the 
other sites and IRBs.  
Copies of reporting of adverse events will be sent to all sites.  
All 3 sites will work together to determine and report interim results.  
All 3 sites will work together to develop the appropriate documents needed to close a study  
20) Community-Based Participatory Research/Field Research  N/A 
21) Sharing of Results with Subjects/Incidental Findings  
Some of our participants will hear the results of the research at a presentation at the 
Scleroderma Foundation annual conference or the Scleroderma Research Foundation.  We 
will also submit a summary of our findings to be put on the SF and SRF websites and /or 
newsletters.   
22) Resources Available  
  
Janet Poole, PhD, OTR/L (PI), is an occupational therapist and tenured professor of medicine. 
Her research has examined the impact of scleroderma on daily life, including work, 
parenting, leisure activities, and self-management. Sharon Newbill, PhD is an experienced 
qualitative researcher.  Dr. Raisch has a specialty in pharmacy and pharmocoeconomics and 
will help analyze the health-adjusted quality of life years and health utility.   
Dinesh Khanna, MD, MS (co-PI), is a tenured associate professor of medicine, Director of 
the University of Michigan Scleroderma Program, and an expert in patient-reported outcome 
measures, including having served as the PI on an NIH PROMIS project. He has extensively 
published on patient-reported outcomes in different rheumatic diseases. The PIs have worked 
together as a team to develop the Internet self-management program. Dr. Berrocal is an 
Assistant Professor of Statistics at the University of Michigan School of Public Health and 
has extensive knowledge regarding variables used in scleroderma research  
Richard Silver, MD (co-I), Director of the Scleroderma Clinic at the Medical University of 
South Carolina and the MCRC for the Study of Rheumatic Diseases in African Americans 
funded by NIAMS, will help recruit African American patients.   
Other members of the research team consist of, Patient Partners, and Stakeholders from the 
Scleroderma Foundation and Scleroderma Research Foundation. The Patient Partners are  
people with systemic scleroderma who are known to the PIs and have collaborated with the PIs 
in the delivery of education programs at support groups or annual local or national patient 
conferences. The stakeholders are the two national organizations in the United States that 
provide information/educational materials  specifically to people with scleroderma.  Per 
PCORI, teleconference calls are scheduled every 1-2 months.  When patient partners have 
completed the CITI training and are added and approved as study team members, they will be 
trained by Dr. Newbill to co-conduct the focus groups with her.   

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 14 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
Feasibility of your recruitment plan/ access to potential recruits: Systemic scleroderma affects 
women (4-8:1) and the mean age of onset is 50 years. Therefore, our study will recruit more 
women. Both University of Michigan and Medical University of South Carolina scleroderma 
programs see patients with different ethnicities and races at their centers. The University of 
Michigan Scleroderma Program has a patient population of more than 1500 scleroderma 
patients. The Program averages 8-10 new patients per week and has a referral system that 
serves the Midwest, from Chicago through Cleveland. The Program continues to see referrals 
from the northeastern and southern United States as well.  The Scleroderma Program at the 
Medical University of South Carolina complements the University of Michigan, as it has a 
large minority patient population. It averages 1-2 new patients per week and has a referral 
system that serves the southeastern part of the United States.  
Dr. Poole will recruit from the Scleroderma Foundation and Scleroderma Research Foundation 
to allow us to recruit across the United States to reach those in rural and urban areas.  
CTSC resources are NOT being accessed.   
  
23) Prior Approvals/Attachments Requiring Signatures  
Departmental Review Form attached.  
There are no radiation exposures or biological specimens or drugs involved in this study.   
24) Confidentiality  
Direct identifiers (name, address, email address, phone numbers) will be collected and 
maintained to send gift cards, contact participants during intervention, and to contact/remind 
participants to complete questionnaires pre-intervention, post and 6 month follow-up. 
Identifiable data will be stored on a password protected computer in the PIs’ offices until the 
end of the study August 31, 2017.  
There is no tissue collected.  
The PIs and co-Is including the statistician, Veronica Berrocol, PhD at UM will have access to 
the data.    
25) Provisions to Protect the Privacy of Subjects  
Individuals with systemic scleroderma will be recruited from the databases from the  
University of Michigan, the Medical University of South Carolina, and the Scleroderma 
Foundation and Scleroderma Research Foundation websites and through announcements sent 
to local chapters of the Scleroderma Foundation (the investigators have used these sources 
successfully in the past). All potential participants will be instructed to contact the PIs or 
coordinators by phone or email if they are interested in participating in the study. The PIs or 
coordinators will screen participants to ensure that they meet the inclusion criteria. For 
participants meeting the inclusion criteria, the PIs or coordinators will explain the purpose of 
the study and the study procedures. Participants who meet the inclusion criteria and indicate a 

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 15 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
desire to participate in the study will be sent the link to read and complete the consent form. 
The PIs and study coordinators will be available by email or telephone to answer any 
questions. Participants will be directed to complete the pre-intervention questionnaires once 
they review and agree to the electronic consent form or once they have signed a consent form 
in person. Once the pre-intervention questionnaires are completed, the coordinator will refer 
to a random allocation sequence to determine the participant’s assignment to group.  The 
random allocation sequence will be generated by the statistician, Dr. Berrocol.  The 
statistician and investigators will have access to the database with information about the 
participants.  However, the database to be used for statistical analyses will be de-identified.  
PHI is being collected and HIPAA is part of the consent forms.  
  
26) Compensation for Research-Related Injury  
No research related injuries are expected to occur.   
  
27) Economic Burden to Subjects  
There are no costs to participants for being in this study.   
  
28) Consent Process (including waiver request for HIPAA, waiver of HIPAA for 
recruitment only, Waiver of Informed Consent, and Alteration of Informed 
Consent)  
  
Consent  
Individuals with systemic scleroderma will be recruited from the University of Michigan, 
the Medical University of South Carolina, and the Scleroderma Foundation and 
Scleroderma Research Foundation websites and through announcements sent to local 
chapters of the Scleroderma Foundation (the investigators have used these sources 
successfully in the past). All potential participants will be instructed to contact the PIs or 
coordinators by phone or email if they are interested in participating in the study. The PIs 
or coordinators will screen participants to ensure that they meet the inclusion criteria. For 
participants meeting the inclusion criteria, the PIs or coordinators will explain the purpose 
of the study and the study protocol. Participants who meet the inclusion criteria and 
indicate a desire to participate in the study will be sent an email with a link to review and 
complete the electronic consent form through Qualtrics. Thus, the consenting process can 
be done either electronically or in person. The PIs and study coordinators will be 
available to answer any questions by telephone. Once the consent form is completed, 
participants will be directed to complete the pre-intervention questionnaires using 
Qualtrics. The consent form and questionnaires must be completed to participate. Once 
consent is obtained and the pre-intervention questionnaires complete on line through 
Qualtrics, participants will be randomly assigned to a treatment condition.  

Taking charge of systemic sclerosis (NCT02494401) 
  
Page 16 of 16 
Version 08.20.2015  
0 8 .2 0 .201 5   
HIPAA Authorization  
PHI collected includes age, gender, education level, type of scleroderma, ethnicity, length 
of time since disease onset, marital status, and employment status.   This information is 
necessary to describe our population and to ensure our participants in the intervention and 
control groups are similar and for generalization of the findings.    
There is a separate HIPAA authorization form.   
Only English speaking subjects are eligible. No cognitively impaired adults are eligible.  
29) Drugs or Devices  
N/A.  There are no drugs or devices involved with this study