Feasibility study of an experimental social space-oriented rehabilitation concept for people with intellectual and/or multiple disabilities: a study protocol.

INTRODUCTION

The United Nations underlines the participation in all domains of daily living for people with intellectual and/or multiple disabilities in the Disability Rights Convention, which also includes medical services. In line with this, the German Federal Participation Act has further developed the relevant disability policy at the national level. This also implies access to comprehensive medical care. In 2015, Germany created a legal basis for the establishment of medical centres for adults with intellectual and/or multiple disabilities in order to ensure basic medical care for these patients. However, the medical centres cannot provide complex rehabilitation. Mobile rehabilitation can be another tool to address the underuse of medical rehabilitation for people with intellectual and/or multiple disabilities. Mobile rehabilitation refers to rehabilitation services provided in a patient's home or local community, rather than in a traditional inpatient or outpatient rehabilitation facility. The advantages of mobile rehabilitation are its accessibility for patients with mobility problems, the comfort of a familiar environment, which can reduce stress, and the fact that rehabilitation can be tailored to the patient's living conditions and daily routine. In Germany, mobile rehabilitation is currently only available in the field of geriatrics.Within the framework of the feasibility study 'Social space-oriented individualised medical rehabilitation for people with intellectual and/or multiple disabilities (SIMRE),' a social space-oriented rehabilitation concept was developed to close the rehabilitation gap for people with intellectual and/or multiple disabilities. It is funded by the German Federal Ministry of Health. This study protocol describes the procedure of this feasibility study.

METHODS

This study is a prospective mixed methods feasibility study. The rehabilitation concept combines outpatient and home-based rehabilitation, medical, and therapeutic care for people with intellectual and/or multiple disabilities.

ANALYSIS

The primary target criteria are the feasibility and acceptance of the concept by participants, relatives, carers and the rehabilitation staff. Guided interviews with participants and their relatives and/or carers will be analysed using the content-structuring analysis according to Kuckartz. Quantitative analysis will include a cost-benefit analysis to provide information on the economic feasibility of the rehabilitation concept. Changes in individual participation, quality of life and rehabilitation goals will be assessed using a before-and-after comparison with questionnaires. The frequency and type of rehabilitation procedures used will be evaluated quantitatively.The trial was prospectively registered in the German Clinical Trials Register on 17 August 2023. (https://www.drks.de/DRKS00032493).

ETHICS AND DISSEMINATION

Ethical approval was granted by the Ethics Committee of Hannover Medical School (reference number: 10985_BO_S_2023).1. Publication: The results of the project will be made available to the public through open access publications. We plan to develop a treatment guideline for the treatment concept based on clinical experience.2. Widespread implementation: If the project is continued and adequately staffed, the rehabilitative care concept could be implemented nationwide, and the University Hospital could be available as a reference clinic.

TRIAL REGISTRATION NUMBER

German Clinical Trials Register (reference number: DRKS00032493).