Background: Patients with inflammatory bowel disease (IBD) suffer from various physical as well as psychological impairments, and patient education may help improve their well-being. Therefore, we developed a manualized education program for IBD patients addressing medical and psychological issues. This study aimed to evaluate it in a large controlled trial. Methods: A total of 181 IBD outpatients participated in a prospective, randomized, waitlist-controlled trial; assessments were made before as well as 2 weeks and 3 months after intervention. Analysis of covariance was used to assess intervention effects on disease-related worries and concerns (primary outcome), fear of progression, coping with anxiety, health competencies, health-related quality of life (HRQoL), perceived disease activity, symptoms of depression and anxiety, disease-related knowledge, and coping strategies. Participants' satisfaction with the program was also evaluated. Results: At 2 weeks and 3 months after intervention, we found significant large effects of our education program on skill and technique acquisition, knowledge, and coping with IBD. Moreover, we found significant medium effects on disease-related worries and concerns, fear of progression, coping with anxiety, constructive attitudes and approaches, as well as coping with disease-related negative emotions. The number of coping strategies used was significantly higher at 3 months. We did not find any effects on perceived disease activity, HRQoL, positive and active engagement in life, or symptoms of anxiety and depression. The program was rated very favorably by the attendees. Conclusion: Our education program contributed to improvements in psychological distress, self-management skills, and coping and was appreciated by its attendees.
Although inflammatory bowel disease (IBD) affects patients' psychological well-being, previous educational programs have failed to demonstrate effects on psychosocial outcomes and quality of life. Therefore, we developed a group-based psychoeducational program that combined provision of both medical information and psychological self-management skills, delivered in an interactive manner, and evaluated it in a large, cluster-randomized trial. We assigned 540 rehabilitation inpatients suffering from IBD (mean age 43 years, 66% female) to either the new intervention or a control group comprising the same overall intensity and the same medical information, but only general psychosocial information. The primary outcome was patient-reported IBD-related concerns. Secondary outcomes included disease knowledge, coping, self-management skills, fear of progression, anxiety, depression and quality of life. Assessments took place at baseline, end of rehabilitation and after 3 and 12 months.The psychoeducational self-management program did not prove superior to the control group regarding primary and secondary outcomes. However, positive changes over time occurred in both groups regarding most outcomes. The superior effectiveness of the newly developed psychoeducational program could not be demonstrated. Since the intervention and control groups may have been too similar, this trial may have been too conservative to produce between-group effects.
The Inflammatory Bowel Disease Competence Network is a network of more than 500 physicians and scientists from university clinics, hospitals and gastroenterology practices. The focus extends from the two major forms of inflammatory bowel diseases, Crohn's disease and ulcerative colitis, into other chronic inflammatory conditions affecting the intestine, including coeliac disease and microscopic colitis. The network translates basic science discoveries (in particular in the molecular epidemiology research) into innovative diagnostics and therapy. Through its strong networking structures it supports a continuous process to improve quality and standardisation in patient care that is implemented in close interaction with European networks addressing this disease group.Optimisation of patient care based on scientifically proven evidence is a main focus of the network. Therefore, it supports and coordinates translational research and infrastructure projects that investigate aetiology, improvement of diagnostic methods, and development of new or improved use of established therapies. Members participate in various training projects, thus ensuring the rapid transfer of research results into clinical practice.The competence network cooperates with the main patient organisations to engage patients in all levels of activities. The network and the patient organisations have interest in promoting public awareness about the disease entities, because their importance and burden is underestimated in non-specialised medical fields and among the general public.
Vedolizumab, the first drug in the class of anti-integrin molecules, is newly approved for ulcerative colitis and Crohn's disease and can be prescribed in Germany since mid-2014. By a specific receptor binding a relatively gut-selective mode of action was achieved without the known side effects of the systemic immunosuppression of the anti-TNF-alpha antibodies. According to the present data the safety profile of Vedolizumab appears to be more favorable than that of the anti-TNF-alpha therapy. Vedolizumab is suitable for induction therapy in patients with ulcerative colitis and Crohn's disease, however the kinetic of response compared with the anti-TNF-alpha antibodies seems to be slower. For maintenance therapy the Vedolizumab data show a deep and sustained remission in patients initially responding to induction therapy with a lower loss of efficacy in the long-term treatment known from the anti-TNF-alpha therapy. On the basis of currently available data the efficacy of Vedolizumab in ulcerative colitis appears to be slightly better than in Crohn's disease. Abstract:Vedolizumab, the first drug in the class of anti-integrin molecules, is newly approved for ulcerative colitis and Crohn's disease and can be prescribed in Germany since mid-2014. By a specific receptor binding a relatively "gut-selective" mode of action was achieved without the known side effects of the systemic immunosuppression of the anti-TNFα antibodies.According to the present data the safety profile of Vedolizumab appears to be more favorable than that of the anti-TNFα therapy.Vedolizumab is suitable for induction therapy in patients with ulcerative colitis and Crohn's disease, however the kinetic of response compared with the anti-TNF-alpha antibodies seems to be slower. For maintenance therapy the Vedolizumab data show a deep and sustained remission in patients initially responding to induction therapy with a lower loss of efficacy in the long-term treatment known from the anti-TNF-alpha therapy. On the basis of currently available data the efficacy of Vedolizumab in ulcerative colitis appears to be slightly better than in Crohn's disease.Schlüsselwörter: Vedolizumab, Colitis ulcerosa, Morbus Crohn, anti-TNFα-Antikörper
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