Inflammatory bowel disease – more than an inflammation of the bowel: Somatic and psychosocial problems and patient empowerment
Background: In case of inflammatory bowel disease (IBD) criteria of good patient care include a comprehensive perception of current physical, emotional and social problems. In 2009, evidence-based and consented IBD care guidelines were published, which recommended a systematic assessment of these problems and focused on a multidisciplinary but local patient-centered care. One of the main goals was to include the patient more in decision-making and to empower them.
Methods: A RCT was constructed to test the hypotheses that patients with Crohn´s disease (CD) or ulcerative colitis (UC) will benefit from a patient-centered care based on the assessment of the IBD care guidelines. Defined primary endpoints were (i) health related quality of life and (ii) social participation. The study population included all members of a German health insurance (Techniker Krankenkasse) which were at least once on sick leave or hospitalized with the diagnoses of CD or UC (ICD-10 K50 or K51) in 2009/2010. Out of this study population a random sample received a request to join the study. To all persons who declared their willingness to participate a screening questionnaire was send. It covered 22 somatic and psychosocial problems and focused on patient-related outcomes.
Respondees were randomly allocated to an intervention (IG) or control group (CG). All members of the IG received an individualized written analysis of their problem assessment together with recommendation based on the IBD guideline. Further were they encouraged to talk with their GPs about the problem assessment and the recommendations they got. Members of the control group were informed about the result of the randomization.
After 12 month (august in 2012) a second questionnaire was send out. Complementary, the utilization of health services was documented based on the data from the health insurance company.
Current status: The search in the health insurance database identified a total of 5,075 persons with suspected CD or UC. 2,500 received a request to join the study. Out of them 790 expressed their interest and received the study documents (questionnaire, project description and declaration of consent). 545 returned the questionnaire for evaluation (response rate 69%). After controlling for all inclusion and exclusion criteria 514 persons (♂ 232, ♀ 282) were included in the study and randomly allocated to the IG (258) or CG (256). This shows that the recruitment goal of including 180 persons in each group was reached. Current research results are presented at poster. At present an internet-based version of the assessment questionnaire, is being generated were the answers will be analyses automatically.
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