Inviting patients with inflammatory bowel disease to active involvement in their own care: A randomized controlled trial

Background: Inflammatory bowel diseases impose on patients a broad spectrum of somatic and psychosocial burden. We hypothesized that patients' self-responsibility in planning and initiating adequate usually multimodal health care can be supported by self-assessment and proactive information, thus improving health-related quality of life and social participation. Methods: We conducted a randomized controlled trial among a random sample of adult members of a German statutory health insurance with Crohn's disease or ulcerative colitis with at least 1 inflammatory bowel diseases-related hospital stay or sick leave in 2009 or 2010. Five hundred fourteen patients completed a postal screening questionnaire inquiring about 22 problems. The intervention group (IG) received an automated data analysis with individualized written advice on appropriate health services, and the control group received usual care. Main outcomes were health-related quality of life and social participation. Secondary outcomes included health care utilization, number of screened problems, and self-management skills. Results: After 12 months, small beneficial effects were seen for all primary outcomes in the IG: EuroQol visual analog scale score (difference between IG and control group: 4.4; 95% confidence interval, 7.7-1.0; P = 0.011), index for measuring participation restriction (IMET) score (difference between IG and control group: 0.4; 95% confidence interval, 0.07-0.62; P = 0.013). The number of disability days improved only in the IG. The IG reported significantly fewer outpatient visits, fewer disease-related problems, and improved self-management skills (health education impact questionnaire scores) with no increase in disease activity, hospital stays, or consultations with allied health professionals. Conclusions: Our activation and information procedure is effective and beneficial. Further studies might show its usefulness in comprehensive management of patients with inflammatory bowel diseases.