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.
Professional Abstract
Objective
To compare the effect of an online scleroderma self-management program versus a scleroderma textbook on self-efficacy among adults with scleroderma
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 267 adults with a scleroderma diagnosis and access to a computer and the internet |
| Interventions/ Comparators |
|
| Outcomes |
Primary: self-efficacy (PROMIS® domain of managing symptoms) Secondary: self-efficacy (PROMIS domains of daily activities, medications and treatments, emotions, and social interactions), patient activation, health-related quality of life, health status, satisfaction with appearance |
| Timeframe | 6-month follow-up for primary outcome |
This randomized controlled trial compared an online scleroderma self-management program designed to increase self-efficacy for symptom management among patients with systemic sclerosis, or scleroderma, with a textbook on scleroderma. Researchers randomized patients to receive either the scleroderma self-management program or the textbook.
- The self-management program included 15 modules on topics such as coping and body image, exercise, self-advocacy, and pain management. Patients in the self-management program reviewed the modules online once a week for four months.
- The Scleroderma Book included information on scleroderma terms and types, epidemiology, effects of scleroderma on different organ systems, skills for communicating with health professionals, and living with an unpredictable disease. Patients in this group could read the book over the course of four months.
The study included 267 adult patients with scleroderma from two university-based scleroderma centers and two scleroderma foundations. Of these, 83% were white, 8% were African American, 6% were multiracial, and 3% were other races. The average age was 54, and 91% were female. In addition, 79% of patients had a college degree or higher and 60% reported the highest level of patient activation, or confidence in managing one’s health, at baseline based on the Patient Activation Measure. The average patient-reported disease duration was nine years since diagnosis.
Patients completed online surveys about outcomes at baseline and four and six months later.
Patients with scleroderma and representatives from scleroderma foundations helped choose outcomes, develop the self-management program, and recruit participants. A patient with scleroderma served as a co-investigator.
Results
Groups did not differ significantly in any self-efficacy domains at four- or six-month follow up.
Compared with patients who received the textbook, patients in the self-management program
- Reported greater improvements in health status at the four-month (p=0.05) and six-month (p=0.008) follow-up
- Had greater decreases in fatigue scores at the six-month follow-up (p=0.04)
The two groups did not differ in any other health-related quality of life subscales, patient activation, or satisfaction with appearance at either follow-up time point.
Limitations
Most participants in the study were white, well-educated women with high patient activation at the start of the study. Also, most patients had lived with scleroderma for about nine years. Results may differ for people from other backgrounds or with less experience managing the condition.
Conclusions and Relevance
Among patients with scleroderma, the self-management program did not improve self-efficacy, but it improved patients’ self-reported health status and fatigue.
Future Research Needs
Future research could test the self-management program among patients with lower patient activation levels, less time since diagnosis, and from more diverse backgrounds.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
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.