Clinical trial NCT06058351: ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury
Official title: ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury; an Implementation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Acquired Brain Injury
Rehabilitation
Aftercare
Implementation
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Brain Foundation
First posted: 2023-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A group of patients will be followed during standard outpatient rehabilitation before and after implementation of the ABI-motion program with 1 year follow-up.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this implementation study is to improve aftercare for patients with ABI receiving outpatient rehabilitation. The ABI-motion program was developed to improve and active lifestyle and to prevent persistent complaints after ABI and poor HR-QoL.The main questions it aims to answer are:

* Is the ABI-motion program feasible?
* What are the health benefits of the ABI-motion program?

Participants will receive brain education, a joint therapy session with a physical or occupational or movement therapist and a buddy from a patient support organization during outpatient rehabilitation, followed by community buddy support after discharge from outpatient rehabilitation, and follow-up by a rehabilitation physician.

Detailed description: Rationale: Many people with acquired brain injury (ABI) experience difficulties in reintegration into their social life after discharge from the rehabilitation center. It is also known that people with ABI do not meet the physical activity guidelines; they have lower physical activity levels than healthy people and they have difficulty maintaining their physical fitness level reached during rehabilitation. An inactive lifestyle may lead to persistent complaints, such as fatigue, anxiety or depression, and may result in a poor health-related quality of life (HR-QoL).

Objective: To improve aftercare for patients with ABI receiving outpatient rehabilitation, aimed at promoting an active lifestyle to prevent persistent complaints after ABI and poor HR-QoL.

Study design: Care improvement study using a prospective mono-center cohort with a pre-post implementation study design.

Study population: Patients with ABI receiving outpatient rehabilitation therapy.

Intervention (if applicable): Implementation of an aftercare program that strengthens the cooperation between rehabilitation center and local patient support organisations in the community. The aftercare program integrates standard outpatient rehabilitation and community services, including: 1) brain education regarding long-term consequences of ABI, physical activity guidelines, and patient support organizations in the area; 2) a joint physical/ occupational/ movement therapy session with a buddy from a patient support organisation during outpatient rehabilitation; 3) buddy support (max 8 hrs) in the community towards an active lifestyle after rehabilitation discharge; 4) follow-up by the rehabilitation physician.

Main study parameters/endpoints: The proportion of participants with ABI participating in the community buddy program (target 60%) and feasibility (rating of satisfaction) of the program will be calculated. Secondary, objectively measured physical activity, physical fitness and cognitive functioning and patient reported outcomes (physical activity, fatigue, anxiety, depression, cognitive complaints, coping, community integration, HRQoL, physical fitness, health care use, return to work) using validated questionnaires will be collected before and at 3, 6, and 12 months after outpatient rehabilitation discharge.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with ABI
* Follows an outpatient rehabilitation program for ABI in Rijndam Rehabilitation

Exclusion Criteria:

* Having a contra-indication for participation in moderate to vigorous exercise
* Life expectancy \< 1 year
* Incapacitated persons

Primary outcomes:
measure: Difference in proportion of patients participating in buddy support programs after rehabilitation discharge
timeFrame: 3, 6, 12 months
measure: Mean rating of satisfaction with the ABI-motion program
timeFrame: 12 months
Secondary outcomes:
measure: Change in total minutes of physical activity/week at 6 and 12 months compared with controls
timeFrame: 0, 6, 12 months
measure: Change in Montreal Cognitive Assessment (MoCA) score at 6 and 12 months compared with controls.
timeFrame: 0, 6,12 months
measure: Change in functional exercise capacity at 6 and 12 months compared with controls
timeFrame: 0, 6, 12 months
measure: Change in Walking Speed at 6 and 12 months compared with controls
timeFrame: 0, 6, 12 months
measure: Change in handgrip strength at 6 and 12 months compared with controls
timeFrame: 0, 6, 12 months
measure: Change in anxiety and depression at 3, 6, and 12 months compared with controls
timeFrame: 0, 3, 6, and 12 months
measure: Change in fatigue at 3, 6, and 12 months compared with controls
timeFrame: 0, 3, 6, and 12 months
measure: Change in cognitive failures at 3, 6, and 12 months compared with controls
timeFrame: 0, 3, 6, and 12 months
measure: Change in coping style at 3, 6, and 12 months compared with controls
timeFrame: 0, 3, 6, and 12 months
measure: Change in health-related quality of life at 3, 6, and 12 months compared with controls
timeFrame: 0, 3, 6, 12 months
measure: Change in physical and mental components of health-related quality of life at 3, 6, and 12 months compared with controls
timeFrame: 0, 3, 6, 12 months
measure: Change in physical activity at 3, 6,12 months compared with controls
timeFrame: 0, 3, 6, 12 months
measure: Change in fitness at 3, 6,12 months compared with controls
timeFrame: 0, 3, 6, 12 months
measure: Change in social participation and health care use at 3, 6, 12 months compared with controls
timeFrame: 0, 3, 6, 12 months
measure: Change in health care use at 3, 6, 12 months compared with controls
timeFrame: 0, 3, 6, 12 months
measure: Change in medical consumption at 3, 6, 12 months compared with controls
timeFrame: 0, 3, 6, 12 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Rijndam Rehabilitation
Study officials:
affiliation: Erasmus Medical Center
name: Gerard M Ribbers, MD, PhD
role: STUDY_CHAIR
References: