BACKGROUND: The poor evidence base is a major problem for the German rehabilitation sector. This trial focused on testing the efficacy and benefit of inpatient medical rehabilitation compared to routine care in a single common entity, namely, chronic inflammatory bowel disease (IBD). METHODS: This pragmatic, multicenter, randomized controlled trial with a parallel group design included gainfully employed patients with IBD who were covered by one of four statutory health insurance providers. Patients in the intervention group were actively advised regarding options for rehabilitation and given support in applying for it; patients in the control group continued with the care they had been receiving before participation in the trial. The primary endpoint was social participation, and there were various secondary endpoints, including disease activity and sick days taken off from work. All parameters were assessed by questionnaire at the beginning of the trial and twelve months later. This was trial no. DRKS00009912 in the German clinical trials registry. RESULTS: In a complete case analysis, the intervention group (211 patients, of whom 112 underwent rehabilitation) did better than the control group (220 patients, of whom 15 underwent rehabilitation) in multiple respects. The reported limitation in social participation was reduced by 7.3 points in the intervention group and 2.9 points in the control group (p = 0.018; d = 0.23). Significant improvements were also seen in disease activity, vitality, health-related quality of life, and self-management, with effect sizes between 0.3 and 0.4. No benefit was seen in outcomes related to working capacity. Sensitivity analyses lent further support to the findings. CONCLUSION: Rehabilitation research can be conducted with individually randomized, controlled trials. The findings of this trial indicate the absolute effectiveness of ied rehabilitation for IBD patients, as well as its additional benefit compared to routine care.
RCT Entities:
BACKGROUND: The poor evidence base is a major problem for the German rehabilitation sector. This trial focused on testing the efficacy and benefit of inpatient medical rehabilitation compared to routine care in a single common entity, namely, chronic inflammatory bowel disease (IBD). METHODS: This pragmatic, multicenter, randomized controlled trial with a parallel group design included gainfully employed patients with IBD who were covered by one of four statutory health insurance providers. Patients in the intervention group were actively advised regarding options for rehabilitation and given support in applying for it; patients in the control group continued with the care they had been receiving before participation in the trial. The primary endpoint was social participation, and there were various secondary endpoints, including disease activity and sick days taken off from work. All parameters were assessed by questionnaire at the beginning of the trial and twelve months later. This was trial no. DRKS00009912 in the German clinical trials registry. RESULTS: In a complete case analysis, the intervention group (211 patients, of whom 112 underwent rehabilitation) did better than the control group (220 patients, of whom 15 underwent rehabilitation) in multiple respects. The reported limitation in social participation was reduced by 7.3 points in the intervention group and 2.9 points in the control group (p = 0.018; d = 0.23). Significant improvements were also seen in disease activity, vitality, health-related quality of life, and self-management, with effect sizes between 0.3 and 0.4. No benefit was seen in outcomes related to working capacity. Sensitivity analyses lent further support to the findings. CONCLUSION: Rehabilitation research can be conducted with individually randomized, controlled trials. The findings of this trial indicate the absolute effectiveness of ied rehabilitation for IBDpatients, as well as its additional benefit compared to routine care.
Authors: Michael Schuler; Gunda Musekamp; Hermann Faller; Inge Ehlebracht-König; Christoph Gutenbrunner; Roland Kirchhof; Jürgen Bengel; Sandra Nolte; Richard H Osborne; Monika Schwarze Journal: Qual Life Res Date: 2012-09-18 Impact factor: 4.147
Authors: A Reusch; R Weiland; C Gerlich; K Dreger; C Derra; D Mainos; T Tuschhoff; A Berding; C Witte; B Kaltz; H Faller Journal: Health Educ Res Date: 2016-09-20
Authors: Gloria Heesen; Dominik Schröder; Frank Müller; Eva Hummers; Frank Klawonn; Marie Mikuteit; Jacqueline Niewolik; Sandra Steffens; Anne Cossmann; Georg Behrens; Alexandra Dopfer-Jablonka; Stephanie Heinemann Journal: Front Public Health Date: 2022-06-10
Authors: Konrad Schultz; Michael Wittmann; Rupert Wagner; Nicola Lehbert; Larissa Schwarzkopf; Boglárka Szentes; Dennis Nowak; Hermann Faller; Michael Schuler Journal: Dtsch Arztebl Int Date: 2021-01-22 Impact factor: 5.594
Authors: Sandra Maria Barbalho; Julia Novaes Matias; Uri Adrian Prync Flato; Joao Paulo Galletti Pilon; Piero Bitelli; Marcos Alberto Pagani Junior; Antonelly Cassio Alves de Carvalho; Jesselina Francisco Dos Santos Haber; Carlos Henrique Bertoni Reis; Ricardo de Alvares Goulart Journal: Gastroenterology Res Date: 2021-02-19