ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury (ABI-motion)

ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury; an Implementation Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Behavioral: ABI-motion program

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Majanka H Heijenbrok-Kal, PhD; Phone Number: +31628129140; Email: m.heijenbrok@erasmusmc.nl
• Study Contact Backup: Name: Erik Grauwmeijer, MD, PhD; Phone Number: +31102412412; Email: e.grauwmeijer@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABI-motion group; Patients following outpatient rehabilitation after implementation of the ABI-motion program	Behavioral: ABI-motion program; The ABI-motion program strengthens the cooperation between outpatient rehabilitation professionals and community care providers.
No Intervention: Control group; Patients following outpatient rehabilitation before implementation of the ABI-motion program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in proportion of patients participating in buddy support programs after rehabilitation discharge	Proportion of patients in the ABI-motion group that continues community buddy support after rehabilitation discharge compared with standard care	3, 6, 12 months
Mean rating of satisfaction with the ABI-motion program	Satisfaction with the ABI-motion program is rated on a rating scale, ranging from 0 (worst) to 10 (best).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total minutes of physical activity/week at 6 and 12 months compared with controls	Physical activity is measured with an activity monitor (min/week) and electronic diary	0, 6, 12 months
Change in Montreal Cognitive Assessment (MoCA) score at 6 and 12 months compared with controls.	The MoCA is a screening tool for detection of mild cognitive impairment. The total score ranges from 0 (worst) to 30 (best).	0, 6,12 months
Change in functional exercise capacity at 6 and 12 months compared with controls	The 1-minute Sit-to-Stand Test (1mSTS) measures the number of sit-to-stand transitions during 1 minute.	0, 6, 12 months
Change in Walking Speed at 6 and 12 months compared with controls	10 meter Walk Test (10mWT) assesses walking speed (m/s) over a short duration.	0, 6, 12 months
Change in handgrip strength at 6 and 12 months compared with controls	Maximum isometric handgrip strength is measured with a hand-held dynamometer over 6 attempts (3 per hand) in kg.	0, 6, 12 months
Change in anxiety and depression at 3, 6, and 12 months compared with controls	The Hospital Anxiety and Depression Scale (HADS) subscale scores are used to measure Anxiety and Depression, 7 items each, with subscale scores ranging from 0 (best) to 21 (worst), with scores 0-7 indicating normal sores, 8-10 borderline cases, and 11-21 definite cases of anxiety or depression.	0, 3, 6, and 12 months
Change in fatigue at 3, 6, and 12 months compared with controls	The Checklist Individual Strength (CIS) consists of 20 statements on fatigue-related problems respondents might have experienced in the past 2 weeks. The items are rated on a 1-7 point Likert scale, with total scores ranging from 20 (best) to 140 (worst).	0, 3, 6, and 12 months
Change in cognitive failures at 3, 6, and 12 months compared with controls	The Cognitive Failures Questionnaire (CFQ) is used to assess the frequency with which people experience cognitive failures in everyday life, such as absent-mindedness, slips and errors of perception, memory, and motor functioning. The total score of the scale is the sum of the ratings of the 25 individual items, yielding a score from 0 (best) to 100 (worst).	0, 3, 6, and 12 months
Change in coping style at 3, 6, and 12 months compared with controls	The short version of the Coping Inventory for Stressful Situations (CISS-SF) is used as a measure of coping with stressful situations. It has 21 items which are rated on a 1(no) to 5 (strong) point rating scale. It contains 3 subscales: task-oriented, emotion-oriented, and avoidance-oriented coping. Each subscale score ranges from 7 (low use) to 35 (high use), with higher scores indicating a greater use of that particular coping strategy.	0, 3, 6, and 12 months
Change in health-related quality of life at 3, 6, and 12 months compared with controls	The EQ-5D-5L consists of the 5-item EQ-5D index (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (EQ VAS). The 5 EQ-5D index items are summarized into a weighted overall score, which runs from 0 for the value of death to 1.00 for full health. The EQ VAS ranges from 0 to 100 (worst to best imaginable health state).	0, 3, 6, 12 months
Change in physical and mental components of health-related quality of life at 3, 6, and 12 months compared with controls	The Short Form-36 contains 36 items measuring multidimensional quality of life. A physical component summary (PCS) and a mental component summary (MCS) can be calculated, which are T-scores, having a mean of 50 and standard deviation of 10.	0, 3, 6, 12 months
Change in physical activity at 3, 6,12 months compared with controls	The International Physical Activity Questionnaire assesses the time spent (min. per week) in several types of physical activity (vigorous activities, moderate activities, walking, and sitting) that people do as part of their daily lives.	0, 3, 6, 12 months
Change in fitness at 3, 6,12 months compared with controls	The International Fitness Scale (IFIS) questionnaire gives a measure of fitness based on the answers to 5 basic questions about fitness: physical fitness, cardiorespiratory fitness, muscular fitness, speed-agility, flexibility, and overall fitness, with answers based on a 5-point Likert-scale (1=very poor, to 5=very good).	0, 3, 6, 12 months
Change in social participation and health care use at 3, 6, 12 months compared with controls	The Utrecht Scale for Evaluation of Rehabilitation - Participation (USER-P) contains 32 questions with three scales measuring the frequency of participation, perceived participation restrictions, and satisfaction with participation in society. Total scores range from 0 (worst) to 100 (best).	0, 3, 6, 12 months
Change in health care use at 3, 6, 12 months compared with controls	The iMTA Medical Consumption Questionnaire is an instrument to measure medical consumption. It includes questions related to the frequency of contacts with health care providers.	0, 3, 6, 12 months
Change in medical consumption at 3, 6, 12 months compared with controls	The iMTA Productivity Cost Questionnaire (iPCQ) is used to measure the costs (Dollars and/or Euros) of productivity losses.	0, 3, 6, 12 months

Collaborators and Investigators

• Sponsor: Majanka H. Heijenbrok-Kal, PhD
• Collaborators: Netherlands Brain Foundation
• Investigators: Study Chair: Gerard M Ribbers, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Implementation; Acquired Brain Injury; Aftercare
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: 11172 (REB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No