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Manual-Based Vocational Rehabilitation Program for Patients With Acquired Brain Injury

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ClinicalTrials.gov Identifier: NCT03086031
Recruitment Status : Not yet recruiting
First Posted : March 22, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborators:
University of Copenhagen
Rigshospitalet, Denmark
Hospital de Cruces
Information provided by (Responsible Party):
Brain Injury Center BOMI, Roskilde, Denmark

Brief Summary:

An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed.

This study is an interventional, two-arm, 6-month follow-up, cluster randomized controlled trial involving four municipalities in the Zealand Region and the Capital Region of Denmark. A total of 84 patients with ABI evenly distributed across four municipalities will be included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR intervention provided by a specialized Brain Injury Centre or the conventional VR provided by the municipalities (usual care). The 6-9 month intervention will consist of individual and group therapies as well as a work placement program including supported employment. Furthermore, the intervention will include a family intervention program followed up by support to one individual family caregiver. The primary outcomes are increased work or study rate at 6-month follow-up. Moreover, a budget impact analysis and possibly a cost utility analysis of the intervention will be performed The program is one of the first to include a comprehensive and target VR intervention including multiple parties such as the municipalities, a specialized rehabilitation team, and patients' own family caregivers. If this intervention is proven successful when compared to the conventional VR, it will provide evidence for a manual-based individualized holistic approach in returning to work after an ABI.

The first hypothesis of the study is that more participants allocated to the VR intervention group will have a significant higher employment/study rate (measured in hours) at 6-month follow-up when compared to participants receiving the conventional VR program provided by the municipalities (control group). The second hypothesis is that health-related quality of life (HRQoL) and disability among the participants as well as the HRQoL and caregiver burden among the caregivers are significantly improved at the end of the VR intervention and at 6-month follow-up when compared to the conventional VR program. Finally, a budget impact and possibly a cost utility analysis will be performed.


Condition or disease Intervention/treatment Phase
Brain Injuries Behavioral: Program -based vocational rehabilitation intervention Behavioral: Conventional vocational rehabilitation (controls) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In order to avoid confounding between the VR intervention and the control group due to random probability, the number of cases and controls within each of the four municipalities is fixed to be the same (+1/-1). Due to the prospective nature of the inclusion, which practically means that the number of patients included within each municipality is not a priori known, the randomization is performed by randomly assigning the first patient within each municipality to either the VR intervention or the conventional VR program. The following patient (within each municipality) is then assigned consecutive to the other group and so forth. This randomization scheme ensures equal distribution of cases and controls both within each municipality as well as in time avoiding confounding by these two factors.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Due to the nature of the study, it is not possible to blind neither the participants nor the rehabilitation team, but they will be asked not to disclose any details about the allocation, or the content of the VR. The two independent research assistants will be trained to administer the assessments and will be blinded to the allocation when entering data into the database. The researchers and the statistician performing the data analysis are blind to the treatment arm in which the participants are allocated. The rehabilitation team and the research assistants will only be involved in the data collection and will therefore not participate in the data analyses.
Primary Purpose: Health Services Research
Official Title: A Randomised Controlled Trial of a Manual-Based Vocational Rehabilitation Program for Patients With Acquired Brain Injury
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Program-based vocational rehabilitation
Combined intervention with a neuropsychological, social and community intervention followed by a vocational rehabilitation programme with a total length of 6-9 months.
Behavioral: Program -based vocational rehabilitation intervention
The VR intervention lasts for a total of 6-9 months with first six different modules (3-month) that are individually planned, and second a work placement program (approximately 3-6 months). Each of the different modules follows a comprehensive "standard operating procedures" (SOP's). The six modules will be grouped into (a) individual therapies which includes neuropsychological sessions (10-hours), balance between work and everyday life (20-hours), and job matching (10-hours), (b) grouped-based therapies which includes psycho education (18-hours), mindfulness (15-hours), and physiotherapy training (15-hours), (c) an manualized family intervention program (8 sessions of 90 minutes), and an individual caregiver coaching (12-hours), (d) a work placement program including work practice (3-6 month), supported employment by the rehabilitation team (30-hours), and the development of a post rehabilitation plan (4-hours).

Active Comparator: Conventional vocational rehabilitation(controls)
Individuals allocated to the control group will receive the conventional VR program provided by the four municipalities over the same period of time. Thus, the participants in the control group will receive VR support by the local municipal authority that may vary in content and intensity. As for the intervention group, each individual in the control group will select a family caregiver that will go through the same questionnaires as the caregivers in the VR intervention group regarding health-related quality of life and functional level. Furthermore, the case manager at the municipalities will oblige to (1) hand out the baseline questionnaires to the participants and their family caregivers, (2) complete a questionnaire about each participants at the beginning, the end of the study, and again at 6-month of follow-up.
Behavioral: Conventional vocational rehabilitation (controls)
Treatment as usual delivered by the municipalities.




Primary Outcome Measures :
  1. Increased work/study rate at 6-month follow-up [ Time Frame: Measurement assessed at baseline, and after 4 months, 9 months, and 15 months. ]
    The information will be recorded from the involved municipalities own registers and by interviews.


Secondary Outcome Measures :
  1. Proficiency on functional task and functional status [ Time Frame: Measurement assessed at baseline, and after 4 months, 9 months, and 15 months. ]
    Proficiency on functional task and functional status will be measured with The Mayo-Portland Adaptability Inventory (MPAI-4) and Glasgow Outcome Scale Extended

  2. Health related quality of life [ Time Frame: Measurement assessed at baseline, and after 4, 9 months and 15 months. ]
    Health related quality of life would be measured with EuroQol five dimensions questionnaire EQ-5D-3L which measures quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with three statements in each domain coded 1,2, or 3.

  3. Anxiety and depression [ Time Frame: Measurement assessed at baseline, and after 9 and 15 months. ]
    Hospital Anxiety and Depression Scale (HADS) scale are used to measure the symptoms of anxiety and depression in the patients. The final scale has a total of 14 items, with responses being scored on a scale of 0-3 (3 indicates higher symptom frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42.

  4. Fatigue [ Time Frame: Measurement assessed at baseline, and after 4, 9 and 15 months. ]
    The Dutch multifactor Fatigue Scale (DMFS) measures different aspects of fatigue after acquired brain injury. It consists of five dimensions ( 1:Mental fatigue, 2.Physical fatigue, 3.Impact of fatigue, 4.Signs and consequences and 5.Coping with fatigue). It has five subscale scores and no total score.

  5. Physical function [ Time Frame: Measurement assessed at baseline, and after 4 and 15 months. ]
    The Timed Up and Go (TUG) assess mobility by measuring the time (in seconds) used by the patient to walk a line of three meter, turn around and go back again.

  6. Daily activity [ Time Frame: Measurement assessed at baseline, and after 9 and 15 months. ]
    The Worker Role Interview (WRI) is a semi-structured interview designed to be used as the psychosocial/environmental component of the initial rehabilitation assessment process for the injured worker or the worker with a long term disability and poor/limited work history.

  7. Problem Solving Inventory [ Time Frame: Measurement assessed at baseline, and after 4 and 15 months. ]
    The Problem Solving Inventory (PSI) assesses perceptions of the patients problem-solving ability and behaviours and attitudes Associated with problem-solving style. The PSI consists of 35 items with a 6-point Likert scale (1=strongly agree to 6=strongly disagree).

  8. Selv-perceived burden to others [ Time Frame: Measurement assessed at baseline, and after 4,9 and 15 months. ]
    The Self-perceived Burden Scale (SPB) consists of 25 items rated on a five-point scale (1="none of the time" to 5="all of the time).

  9. Executive functions [ Time Frame: Measurement assessed at baseline, and after 4 and 15 months. ]
    TRAIL A and B. The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.

  10. Perceived Stress [ Time Frame: Measurement assessed at baseline, and after 4, 9 and 15 months. ]
    The Perceived Stress Scale (PSS) is a 10-item self-report measurement of stress with scores ranging from 0-4 and a maximum total score of 40.


Other Outcome Measures:
  1. Outcome among Family caregivers (Quality of life). [ Time Frame: Measurement assessed at baseline, and after 4 and 15 months. ]
    EuroQol five dimensions questionnaire EQ-5D-3L; questionnaire EQ-5D-3L which measures quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with three statements in each domain coded 1,2, or 3.

  2. Adaptability and cohesion in the Family towards their new situation with a brain injured Family member. [ Time Frame: Measurement assessed at baseline, and after 4 and 15 months. ]
    The Family Adaptability and Cohesion Scale (FACES-IV) assess Family cohesion and Family flexibility. It consists of 62 items.

  3. Problem Solving Inventory among caregivers [ Time Frame: Measurement assessed at baseline, and after 4 and 15 months. ]
    The Problem Solving Inventory (PSI) assesses perceptions of the problem-solving ability and behaviours and attitudes associated with problem-solving style. The PSI consists of 35 items with a 6-point Likert scale (1=strongly agree to 6=strongly disagree).

  4. Burden among caregivers [ Time Frame: Measurement assessed at baseline, and after 4 and 15 months. ]
    The caregiver burden scale (CBS) is a 22-item self-report Measurement that assess the felt burden among caregiver in taking care of their relatives. The items are scored on a five point likert scale ranging from never (0) to nearly always (4). The the total score is calculated with a total score of 0 to 20 (little or no burden), 21 to 40 (mild to moderate burden), 41 to 60 (moderate to severe burden) and 61 to 88 (severe burden).



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suffers from an acquired brain injury
  • acquired the brain injury within the last 3 to 24 months
  • currently unemployed, but employed/enrolled at an education prior to the injury
  • motivated to participate in vocational rehabilitation
  • able to participate in group sessions
  • able to understand and speak Danish
  • have at least two Family caregivers willing to participate in the study

Exclusion Criteria:

  • have any other somatic or psychiatric illnesses before the acquired brain injury that make it impossible to complete the intervention
  • suffer from substance abuse or severe aphasia
  • have a progressive brain injury
  • are pregnant,
  • have a mini mental state examination score <23.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086031


Contacts
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Contact: Trine Schow, MPH, PhD +45 30 84 44 81 trineshow@bomi.roskilde.dk
Contact: Kirsten Krogh Jensen, MBA +45 46 34 86 63 kirstenkj@bomi.roskilde.dk

Sponsors and Collaborators
Brain Injury Center BOMI, Roskilde, Denmark
University of Copenhagen
Rigshospitalet, Denmark
Hospital de Cruces
Investigators
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Study Director: Kirsten krogh Jensen, MBA Brain Injury Center BOMI

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brain Injury Center BOMI, Roskilde, Denmark
ClinicalTrials.gov Identifier: NCT03086031     History of Changes
Other Study ID Numbers: 2016-41-4950
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The identified individual participant data for all primary and secondary outcome measures might be interesting in follow-up analyses or in case-reports depending on the results of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brain Injury Center BOMI, Roskilde, Denmark:
Traumatic brain injury, Vocational rehabilitation, Caregiver intervention,

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System