German Clinical Trials Register

Acronym/abbreviation of the study

FaPP-MgB

URL of the study

http://projekt-besser.de/

Brief summary in lay language

Adults with intellectual disabilities are a group with unequal healthcare compared to the general population. They often have difficulties in accessing prevention (avoiding (worsening of) illnesses) and health promotion (improving health) services, e.g. due to communication difficulties. At the same time, there are only few programmes in this field that are specifically tailored to them. Due to the lower availability and uptake of existing services by people with intellectual disabilities, they: 1) have greater risk of developing certain diseases earlier, 2) have a higher risk of unhealthy eating habits, 3) have a higher level of stress, 4) are less physically active and 5) are at a comparable risk of addiction to the general population. In this study, a new form of care will be tested. Nurses with special knowledge and skills will be employed. These are called advanced practice nurses (ANP). These ANPs will carry out four home visits. The aim of these home visits is to assess a) how the participants are doing health-wise, b) which health promotion and prevention topics the participants need support or have problems, c) draw up a prevention plan together with the participants with concrete possibilities for prevention and d) support of long-term stabilization of health-promoting behaviors. Participants are adults with an intellectual disability in Hamburg, Germany. In order to participate, these people must be at least 18 years old and motivated to actively participate. The participants are divided into two groups: An intervention group and a control group. The intervention group will receive the visits from the ANPs described above. The participants in the control group will initially continue to receive the same care as before. After twelve months, the control group also receives visits from the ANPs. The participants are interviewed at the beginning of the study, after six and after twelve months about their general health, their quality of life and their ability to react to health-related challenges.

Brief summary in scientific language

Background: Adults with intellectual disabilities are a group with unequal healthcare compared to the general population. They often have difficulties in accessing prevention and health promotion services, e.g. due to communication difficulties. At the same time, there are only few programmes in this field that are specifically tailored to them. Due to the lower availability and uptake of existing services by people with intellectual disabilities, they: 1) have greater risk of developing certain diseases earlier, 2) have a higher risk of unhealthy eating habits, 3) have a higher level of stress, 4) are less physically active and 5) are at a comparable risk of addiction to the general population. Aim: The aim of the study is to improve the individual health situation, resilience and health-related quality of life through specific case management and specialised nursing expertise within a complex intervention. Methodology: The multicentre randomized-controlled trial with waiting list will be conducted in all seven districts in Hamburg. 256 adults with intellectual disabilities will be included. Inclusion criteria are the presence of a diagnosis F70-F79 and an age of at least 18 years. The primary outcome measure is the health status after 12 months. Secondary endpoints are health-related quality of life at 6 and 12 months, resilience at 6 and 12 months and health status at 6 months. The study is accompanied by a mixed-methods process evaluation of quantitative and qualitative interviews, inclusive research project and a health economic evaluation.