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

Primary Purpose

Acquired Brain Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ABI-motion program
Sponsored by
Majanka H. Heijenbrok-Kal, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acquired Brain Injury focused on measuring Acquired Brain Injury, Rehabilitation, Aftercare, Implementation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ABI-motion group

    Control group

    Arm Description

    Patients following outpatient rehabilitation after implementation of the ABI-motion program

    Patients following outpatient rehabilitation before implementation of the ABI-motion program

    Outcomes

    Primary Outcome Measures

    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
    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).

    Secondary Outcome Measures

    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
    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).
    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.
    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.
    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.
    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.
    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).
    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).
    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.
    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).
    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.
    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.
    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).
    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).
    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.
    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.

    Full Information

    First Posted
    September 8, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Majanka H. Heijenbrok-Kal, PhD
    Collaborators
    Netherlands Brain Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06058351
    Brief Title
    ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury
    Acronym
    ABI-motion
    Official Title
    ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury; an Implementation Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2026 (Anticipated)
    Study Completion Date
    October 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Majanka H. Heijenbrok-Kal, PhD
    Collaborators
    Netherlands Brain Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acquired Brain Injury
    Keywords
    Acquired Brain Injury, Rehabilitation, Aftercare, Implementation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ABI-motion group
    Arm Type
    Experimental
    Arm Description
    Patients following outpatient rehabilitation after implementation of the ABI-motion program
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients following outpatient rehabilitation before implementation of the ABI-motion program
    Intervention Type
    Behavioral
    Intervention Name(s)
    ABI-motion program
    Intervention Description
    The ABI-motion program strengthens the cooperation between outpatient rehabilitation professionals and community care providers.
    Primary Outcome Measure Information:
    Title
    Difference in proportion of patients participating in buddy support programs after rehabilitation discharge
    Description
    Proportion of patients in the ABI-motion group that continues community buddy support after rehabilitation discharge compared with standard care
    Time Frame
    3, 6, 12 months
    Title
    Mean rating of satisfaction with the ABI-motion program
    Description
    Satisfaction with the ABI-motion program is rated on a rating scale, ranging from 0 (worst) to 10 (best).
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Change in total minutes of physical activity/week at 6 and 12 months compared with controls
    Description
    Physical activity is measured with an activity monitor (min/week) and electronic diary
    Time Frame
    0, 6, 12 months
    Title
    Change in Montreal Cognitive Assessment (MoCA) score at 6 and 12 months compared with controls.
    Description
    The MoCA is a screening tool for detection of mild cognitive impairment. The total score ranges from 0 (worst) to 30 (best).
    Time Frame
    0, 6,12 months
    Title
    Change in functional exercise capacity at 6 and 12 months compared with controls
    Description
    The 1-minute Sit-to-Stand Test (1mSTS) measures the number of sit-to-stand transitions during 1 minute.
    Time Frame
    0, 6, 12 months
    Title
    Change in Walking Speed at 6 and 12 months compared with controls
    Description
    10 meter Walk Test (10mWT) assesses walking speed (m/s) over a short duration.
    Time Frame
    0, 6, 12 months
    Title
    Change in handgrip strength at 6 and 12 months compared with controls
    Description
    Maximum isometric handgrip strength is measured with a hand-held dynamometer over 6 attempts (3 per hand) in kg.
    Time Frame
    0, 6, 12 months
    Title
    Change in anxiety and depression at 3, 6, and 12 months compared with controls
    Description
    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.
    Time Frame
    0, 3, 6, and 12 months
    Title
    Change in fatigue at 3, 6, and 12 months compared with controls
    Description
    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).
    Time Frame
    0, 3, 6, and 12 months
    Title
    Change in cognitive failures at 3, 6, and 12 months compared with controls
    Description
    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).
    Time Frame
    0, 3, 6, and 12 months
    Title
    Change in coping style at 3, 6, and 12 months compared with controls
    Description
    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.
    Time Frame
    0, 3, 6, and 12 months
    Title
    Change in health-related quality of life at 3, 6, and 12 months compared with controls
    Description
    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).
    Time Frame
    0, 3, 6, 12 months
    Title
    Change in physical and mental components of health-related quality of life at 3, 6, and 12 months compared with controls
    Description
    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.
    Time Frame
    0, 3, 6, 12 months
    Title
    Change in physical activity at 3, 6,12 months compared with controls
    Description
    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.
    Time Frame
    0, 3, 6, 12 months
    Title
    Change in fitness at 3, 6,12 months compared with controls
    Description
    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).
    Time Frame
    0, 3, 6, 12 months
    Title
    Change in social participation and health care use at 3, 6, 12 months compared with controls
    Description
    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).
    Time Frame
    0, 3, 6, 12 months
    Title
    Change in health care use at 3, 6, 12 months compared with controls
    Description
    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.
    Time Frame
    0, 3, 6, 12 months
    Title
    Change in medical consumption at 3, 6, 12 months compared with controls
    Description
    The iMTA Productivity Cost Questionnaire (iPCQ) is used to measure the costs (Dollars and/or Euros) of productivity losses.
    Time Frame
    0, 3, 6, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Majanka H Heijenbrok-Kal, PhD
    Phone
    +31628129140
    Email
    m.heijenbrok@erasmusmc.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Erik Grauwmeijer, MD, PhD
    Phone
    +31102412412
    Email
    e.grauwmeijer@erasmusmc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerard M Ribbers, MD, PhD
    Organizational Affiliation
    Erasmus Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    upon request

    Learn more about this trial

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

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