Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058351
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-09-08
Brief Title:
ABI-aftercare in Motion Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury
Sponsor:
Majanka H Heijenbrok-Kal PhD
Organization:
Erasmus Medical Center
Study Overview
Official Title:
ABI-aftercare in Motion Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury an Implementation Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABI-motion
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-QoLThe 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
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 parametersendpoints 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
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 parametersendpoints 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None