Case management and care expertise as a prevention approach for adults with intellectual disabilities (FaPP-MgB): study protocol for a randomized-controlled trial

BACKGROUND: Adults with intellectual disabilities have a higher prevalence of unhealthy eating habits, stress, low levels of mobility, and comparable drug consumption as the general population. Consequently, they suffer from several chronic diseases earlier and more often, but there are fewer prevention and health promotion services including this population. The goal of this study is to determine if an advanced practice nursing approach in the community with home visits is an effective way to improve the health status of adults with intellectual disabilities. METHODS: We will conduct a randomized-controlled trial with waiting list design in Hamburg, Germany. Inclusion criteria are diagnosis ICD F70-F79 and exclusion criteria are care level > 3 according to the German Social Code XI or being at the end-of-life. Participants will be block randomized. The intervention consists of advanced practice nurses performing case management, social space analysis, prevention planning, and counseling through four outreach home visits on nutrition, mobility, addiction, and stress. Comparison is usual care. The primary outcome is health status (WHODAS) after 12 months. Secondary outcomes are health-related quality of life (EQ-5D) and resilience (RS-11) after 6 and 12 months. The calculated sample size is 256 with an estimated dropout of 30%. Raters and analysts will be blinded. Analysis will be performed using ANCOVAs. DISCUSSION: By providing case management and utilizing their nursing expertise, advanced practice nurses will provide valuable input and guidance on prevention and health promotion for people with intellectual disabilities. They will close the gap between health and social care, which is prominent in Germany, through cooperation between the existing care sectors. The findings will be disseminated in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00028771, registered 4 July 2022, Universal Trial Number: U1111-1277–0595.