Rijndam Rehabilitation
Rotterdam, 3015LJ, Netherlands
Location status: Recruiting
NCT Number: NCT06058351
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rotterdam, 3015LJ, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The ABI-motion program strengthens the cooperation between outpatient rehabilitation professionals and community care providers.
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
Time frame: 12 months
Satisfaction with the ABI-motion program is rated on a rating scale, ranging from 0 (worst) to 10 (best).
Time frame: 0, 6, 12 months
Physical activity is measured with an activity monitor (min/week) and electronic diary
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).
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.
Time frame: 0, 6, 12 months
10 meter Walk Test (10mWT) assesses walking speed (m/s) over a short duration.
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.
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.
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).
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).
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.
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).
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.
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.
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).
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Erik Grauwmeijer, MD, PhD
CONTACT
Majanka H Heijenbrok-Kal, PhD
CONTACT
Majanka H. Heijenbrok-Kal, PhD
Other
ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury; an Implementation Study
Acronym: ABI-motion
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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