Randomized-Control Trial of a Self-Management Intervention for Patients With Rheumatoid Arthritis in Northern Taiwan

Friday, 26 July 2019

Su-Hui Chen, PhD
School of Nursing, Chang Gung University of Science and Technology, Taoyuan, Taiwan
Jung-Hua Shao, PhD
School of Nursing, College of Medicine, Chang Gung University, Taoyuan, Taiwan

Background. Rheumatoid arthritis is a chronic, persistent systemic disease which restricts patients’ daily activities, affects different dimensions of quality of life, reduces work capacity, and significant increases health care costs. In recent years, more emphasis has been placed on the role of patients in managing their own chronic disease using self-management approaches. Numerous studies have demonstrated that arthritis self-management programs can benefit patients more than usual care alone.

Purpose: To determine the effectiveness of a joint activity and protection self-management program for patients with rheumatoid arthritis using a randomized controlled trial

Methods: Data were collected from August 2016 to July 2018. Patients with rheumatoid arthritis were recruited when admitted to the rheumatology department of the medical center by the first author. After signed informed consent was obtained, baseline data were collected, including background characteristics, self-management behaviors scores, and the following validated questionnaires: rheumatoid arthritis disease activity (DAS-28), arthritis self-efficacy-pain (ASE-pain), arthritis self-efficacy-other symptoms (ASE-OS), and physical functioning (HAQ). Participants were then randomly assigned to the experimental group, who received 6 weeks of a rheumatoid arthritis self-management intervention based on self-efficacy theory, and a control group, who received standard rheumatology care only. Outcome measures were taken at baseline and at months 2, 3, and 6 after commencement of the intervention. This procedure of random allocation adhered to the principles of the CONSORT flow diagram. Changes in outcome variables over time were compared by generalized estimating equation (GEE) analysis, and the level of significance was set at 0.05.

Results: The 224 participants were randomly assigned to the experimental group (n=112) and the control group (n=112). Of these, 214 participants completed the study (experimental group: 108, control group: 106). The overall withdrawal rate for this study was 4.5%. No significant differences were found in demographic or other variables at baseline between those who dropped out and those who finished the study. Of the participants who completed the study, the average age was 58.83±11.91 years, and the majority were female (n=192, 85.7%), married (n=199, 88.8%), a homemaker (n=99, 44.2%), with no income (n=122, 54.5%), and lived with family (n=212, 94.6%). Alarmingly, 187 (83.5%) reported no previous rheumatoid arthritis education/counselling. The average duration of rheumatoid arthritis was 10.66±8.51 years, and most of the participants had no other chronic disease (n=143, 63.8%). Chi-square analysis and Fisher’s exact test for categorical variables and independent sample t-test for continuous variables indicated no significant differences between groups in these variables (p>.05). GEE analysis compared the changes in outcome variable over time between the study groups; a significant difference between groups in the mean change from baseline at month 2, 3, and 6 would indicate a significant interaction effect. (To save space, we show only the results for interaction of the five terms.) The GEE analysis showed that the mean change over time differed significantly between groups in HAQ scores (at 6th month, B =-1.59, p<.05), ASE-pain (at 6th month, B=3.31, p <.05), and the self-management behaviour variable (at 6th month, B=1.50, p<.05). The interaction between DAS-28 and ASE-OS was not significant, suggesting no intervention effect for these outcomes. The results indicated that, by practicing self-management, patients gradually improved their physical functioning, enhanced their self-efficacy in terms of pain, and increased the behaviors of rheumatoid arthritis joint activity and protection self-management.

Conclusion: For rheumatoid arthritis patients, a theory-based self-management program allows nurses to evaluate and intervene on an individual basis, and boosters provided by phone help patients adhere to long-term behavior changes. Our intervention focused on joint activity and protection self-management behaviors that are easy to learn and perform. We suggest that the program is acceptable, feasible, and the feedback from participants was positive. Future research and practice should focusing on several areas. (1) To develop unique self-management programs that considers cultural circumstances, for example, a specific Chinese rheumatoid arthritis self-management program. (2) A trust relationship is needed between the patient and health care providers on the one hand and researchers on the other, especially regarding the increasing issue of scammers. (3) Since electronic systems are very common in patients’ home, and our self-monitoring and self-evaluation were highly accepted by our participants, computerized self-monitoring and self-evaluation should be investigated as a feasible and effective strategy to increase patients’ self-management of their rheumatoid arthritis.