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
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
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
NCT ID
NCT06058351
First Posted
September 8, 2023
Last Updated
September 21, 2023
Sponsor
Majanka H. Heijenbrok-Kal, PhD
Collaborators
Netherlands Brain Foundation
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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