Taking Charge of Systemic Sclerosis (Scleroderma): Effectiveness of a Self-Management Program for People With Scleroderma

PURPOSE: The purpose of this study was to evaluate the effectiveness of an Internet self-management program in improving self-efficacy and other patient-reported outcome measures in the Patient-Reported Outcomes Measurement Information System (PROMIS). Systemic sclerosis (SSc) is a rare connective tissue disease affecting the skin, vasculature, and internal organs. Many people with SSc do not have access to education programs or support groups. To address the lack of resources, a self-management program was developed. A pilot study found significant improvements in self-efficacy, fatigue, and depression (Poole et al., 2013, 2014). Thus, we designed a robust and an adequately powered randomized controlled trial (RCT).

METHOD: This RCT compared an Internet intervention to an educational book control condition. A total of 267 participants completed online baseline questionnaires, were randomized to the intervention or control condition using a 1:1 ratio and computer-generated block randomization, and were stratified on the basis of scores on the Patient Health Questionnaire–8 (<10, >10) to ensure that groups were similar in terms of depressive symptoms. Inclusion criteria were resident of the United States, diagnosis of SSc, age >18, basic computer literacy, access to a computer with Internet and email capabilities, and communication skills in English.

Participants randomized to the Internet program received a link to the self-management website and a password and user name. Modules covered topics such as systemic sclerosis, advocacy, exercises, management of symptoms and daily activities, organ system involvement, and mouth and teeth care. Modules were opened once a week over 16 wk, and questions regarding the modules were posted weekly on a discussion board. Participants in the control group received an educational book written for people with SSc and had 16 wk to read the book.

Outcomes were measured at baseline and postintervention. The primary outcome was the PROMIS Self-Efficacy for Managing Symptoms. Secondary measures included the PROMIS Self-Efficacy scales of Daily Activities, Medications and Treatments, Emotions, and Social Interactions. Other outcome measures were the PROMIS–29, the Patient Activation Measure (PAM), and the European Quality of Life–5 Dimensions (EQ–5D). Significant differences were determined using t tests, Wilcoxon tests, or Fisher’s exact tests depending on the distribution of the variables.

RESULTS: Participants’ mean age was 53.7 and mean disease duration 9 yr; 91.7% were female, 63% were married, and 50% had a college education; mean PROMIS scores were >40; and 78% were in PAM Level 3 or 4. There were no significant differences between groups at baseline for any measures. The only significant group difference postintervention was for the EQ–5D (p < .05). Participants felt that the content was important, the information was presented clearly, and the website was easy to use and visually appealing. Modules on exercises, management of fatigue, self-advocacy, skin, Raynaud’s phenomenon, and gastrointestinal issues were rated as the most helpful.

CONCLUSION: The results from this RCT did not show that the Internet intervention was superior to the control condition. The high baseline scores for all PROMIS variables and PAM suggest that both groups were already using strategies to manage their disease. The intervention might be more effective for people who are newly diagnosed or at PAM Levels 1 and 2. Comments from the participants in the Internet group were positive.

IMPACT STATEMENT: This study is the largest study conducted to evaluate a self-management program for people with SSc. The content was beneficial to participants and could also be educational for occupational therapy practitioners who work with people with SSc. Findings also suggest that the PAM might be useful to identify and motivate people who may be in need of such a program.

References

Poole, J. L., Mendelson, C., Skipper, B., & Khanna, D. (2014). Taking charge of systemic sclerosis: The effectiveness of an Internet self-management program. Arthritis Care and Research, 66, 778–782. https://doi.org/10.1002/acr.22192

Poole, J. L., Skipper, B., & Mendelson, C. (2013). Evaluation of a mail-delivered, print format, self-management program for persons with systemic sclerosis. Clinical Rheumatology, 32, 1393–1398. https://doi.org/10.1007/s10067-013-2282-7