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NCT Number: NCT06058351

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijndam Rehabilitation

Rotterdam, 3015LJ, Netherlands

Location status: Recruiting

Location contact

Erik Grauwmeijer, PhD

CONTACT

[email protected]

Lianne de Vries, MSc

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABI-motion program

Behavioral

The ABI-motion program strengthens the cooperation between outpatient rehabilitation professionals and community care providers.

Primary outcomes

  1. Difference in proportion of patients participating in buddy support programs after rehabilitation discharge

    Time frame: 3, 6, 12 months

    Proportion of patients in the ABI-motion group that continues community buddy support after rehabilitation discharge compared with standard care

  2. Mean rating of satisfaction with the ABI-motion program

    Time frame: 12 months

    Satisfaction with the ABI-motion program is rated on a rating scale, ranging from 0 (worst) to 10 (best).

Secondary outcomes

  1. Change in total minutes of physical activity/week at 6 and 12 months compared with controls

    Time frame: 0, 6, 12 months

    Physical activity is measured with an activity monitor (min/week) and electronic diary

  2. Change in Montreal Cognitive Assessment (MoCA) score at 6 and 12 months compared with controls.

    Time frame: 0, 6,12 months

    The MoCA is a screening tool for detection of mild cognitive impairment. The total score ranges from 0 (worst) to 30 (best).

  3. Change in functional exercise capacity at 6 and 12 months compared with controls

    Time frame: 0, 6, 12 months

    The 1-minute Sit-to-Stand Test (1mSTS) measures the number of sit-to-stand transitions during 1 minute.

  4. Change in Walking Speed at 6 and 12 months compared with controls

    Time frame: 0, 6, 12 months

    10 meter Walk Test (10mWT) assesses walking speed (m/s) over a short duration.

  5. Change in handgrip strength at 6 and 12 months compared with controls

    Time frame: 0, 6, 12 months

    Maximum isometric handgrip strength is measured with a hand-held dynamometer over 6 attempts (3 per hand) in kg.

  6. Change in anxiety and depression at 3, 6, and 12 months compared with controls

    Time frame: 0, 3, 6, and 12 months

    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.

  7. Change in fatigue at 3, 6, and 12 months compared with controls

    Time frame: 0, 3, 6, and 12 months

    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).

  8. Change in cognitive failures at 3, 6, and 12 months compared with controls

    Time frame: 0, 3, 6, and 12 months

    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).

  9. Change in coping style at 3, 6, and 12 months compared with controls

    Time frame: 0, 3, 6, and 12 months

    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.

  10. Change in health-related quality of life at 3, 6, and 12 months compared with controls

    Time frame: 0, 3, 6, 12 months

    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).

  11. Change in physical and mental components of health-related quality of life at 3, 6, and 12 months compared with controls

    Time frame: 0, 3, 6, 12 months

    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.

  12. Change in physical activity at 3, 6,12 months compared with controls

    Time frame: 0, 3, 6, 12 months

    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.

  13. Change in fitness at 3, 6,12 months compared with controls

    Time frame: 0, 3, 6, 12 months

    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).

  14. Change in social participation and health care use at 3, 6, 12 months compared with controls

    Time frame: 0, 3, 6, 12 months

    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).

  15. Change in health care use at 3, 6, 12 months compared with controls

    Time frame: 0, 3, 6, 12 months

    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.

  16. Change in medical consumption at 3, 6, 12 months compared with controls

    Time frame: 0, 3, 6, 12 months

    The iMTA Productivity Cost Questionnaire (iPCQ) is used to measure the costs (Dollars and/or Euros) of productivity losses.

Study contacts

Contact information is provided by the study sponsor or research team.

Erik Grauwmeijer, MD, PhD

CONTACT

[email protected]

+31102412412

Majanka H Heijenbrok-Kal, PhD

CONTACT

[email protected]

+31628129140

Sponsors and collaborators

Lead sponsor

Majanka H. Heijenbrok-Kal, PhD

Other

Collaborators

  • Netherlands Brain Foundation

Registry information

Official study title

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

Acronym: ABI-motion

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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