Results Summary

What was the research about?

Scleroderma is a rare health problem that causes the skin and internal organs to harden. Symptoms can include joint pain, heartburn, or trouble swallowing. Scleroderma has no cure. Learning to manage it can help patients ease their symptoms. But few programs exist to teach patients how to do so.

In this study, the research team tested an online program to help patients manage scleroderma. The program covered topics such as coping skills, body image, exercise, and pain management. The team wanted to learn if patients who received the program had greater confidence in their ability to manage their health problem compared with those who received a book. The book had information on types of scleroderma, what causes it, its effects on the body, coping skills, and patient resources.

What were the results?

Patients using the online program and patients who received the book didn’t differ in their confidence in their ability to manage their health problem.

Compared with patients who received the book, patients using the online program reported

  • Better health after four and six months
  • Feeling less tired after six months

Patients didn’t differ in quality of life, how confident they felt to manage and improve their health, or how happy they were with how they looked.

Who was in the study?

The study included 267 adult patients with scleroderma who had access to a computer and the internet. Of these, 83 percent were white, 8 percent were African American, 6 percent were multiracial, and 3 percent were other races. The average age was 54, and 91 percent were women. Also, 79 percent of patients had at least a college degree and 60 percent reported the highest level of confidence to manage and improve their health at the start of the study. On average, patients had lived with scleroderma for nine years.

What did the research team do?

The research team assigned patients by chance to either take part in the online program or receive the book. Patients in the online program viewed 15 lessons over four months. Those who received the book had four months to read it.

Patients completed surveys at the start of the study and four and six months later.

Patients with scleroderma and staff from scleroderma foundations gave input throughout the study. A patient co-led the project.

What were the limits of the study?

Most patients in the study were white, well-educated women with confidence in their ability to manage and improve their health. Also, most patients had lived with their disease for about nine years. Results may differ for people from other backgrounds.

Future research could test the program with patients who are less confident in their ability to manage and improve their health. Studies could also include patients at earlier stages of disease and with more diverse backgrounds.

How can people use the results?

Clinics that treat patients with scleroderma can use these results when considering how to help patients manage symptoms at home.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:

  • Reviewers asked that the researchers consider adopting a statistical model that would use all available data in a longitudinal analysis rather than a simple change score from baseline to 16-week postintervention. They also stated that the researchers should have addressed missing data as part of their analyses. Researchers explained that because the 16-week outcomes were their primary outcomes and they did not collect data at interim time points, it was not possible to input missing data and the change from baseline was the most direct measure. Further, the 6-month outcomes were secondary outcome measures. Therefore, using a longitudinal analysis looking at baseline, 16-week, and 6-month outcomes would not be appropriate.
  • Reviewers wondered about the effect of giving the control group a book form of the intervention rather than usual care. The researchers pointed out that the web-based intervention included materials that were not in the book, such as exercise videos, tips and resources, action plans, testimonials, and a discussion board. Also, the web-based intervention could be updated.
  • Reviewers noted that the study provided no evidence that the web-based self-management program is more effective than an educational book, yet the researchers recommended disseminating the internet-based content and conducting further trials. The researchers agreed that the internet program did not perform statistically better than a book but noted that the internet version of the intervention has advantages, including being available to a wide audience without cost and being easy to update.

Conflict of Interest Disclosures

Project Information

Janet L. Poole, PhD
University of New Mexico Health Sciences Center
Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-Management

Key Dates

July 2014
February 2019

Study Registration Information


Has Results
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Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: January 25, 2023