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

NCT03086031 | Unknown

• 1 other identifier: 2016-41-4950
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain Injuries

Keywords

Traumatic brain injury, Vocational rehabilitation, Caregiver intervention,

Outcome Measures

Primary Outcomes (1)

• Increased work/study rate at 6-month follow-up

  The information will be recorded from the involved municipalities own registers and by interviews.

  Measurement assessed at baseline, and after 4 months, 9 months, and 15 months.

Secondary Outcomes (10)

• Proficiency on functional task and functional status

  Measurement assessed at baseline, and after 4 months, 9 months, and 15 months.

• Health related quality of life

  Measurement assessed at baseline, and after 4, 9 months and 15 months.

• Anxiety and depression

  Measurement assessed at baseline, and after 9 and 15 months.

• Fatigue

  Measurement assessed at baseline, and after 4, 9 and 15 months.

• Physical function

  Measurement assessed at baseline, and after 4 and 15 months.

Other Outcomes (4)

• Outcome among Family caregivers (Quality of life).

  Measurement assessed at baseline, and after 4 and 15 months.

• Adaptability and cohesion in the Family towards their new situation with a brain injured Family member.

  Measurement assessed at baseline, and after 4 and 15 months.

• Problem Solving Inventory among caregivers

  Measurement assessed at baseline, and after 4 and 15 months.

Study Arms (2)

Program-based vocational rehabilitation

EXPERIMENTAL

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

Conventional vocational rehabilitation(controls)

ACTIVE COMPARATOR

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)

Interventions

Program -based vocational rehabilitation intervention BEHAVIORAL

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).

Program-based vocational rehabilitation

Conventional vocational rehabilitation (controls) BEHAVIORAL

Treatment as usual delivered by the municipalities.

Conventional vocational rehabilitation(controls)

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brain Injury Center BOMI, Roskilde, Denmark: lead
• University of Copenhagen: collaborator
• Rigshospitalet, Denmark: collaborator
• Hospital de Cruces: collaborator

Related Publications (1)

• Hoeffding LK, Nielsen MH, Rasmussen MA, Norup A, Arango-Lasprilla JC, Kjaer UK, Burgdorf KS, Quas KJ, Schow T. A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT). Trials. 2017 Aug 10;18(1):371. doi: 10.1186/s13063-017-2115-0.

  PMID: 28793916 DERIVED

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kirsten krogh Jensen, MBA

  Brain Injury Center BOMI

  STUDY DIRECTOR

Central Study Contacts

Trine Schow, MPH, PhD

CONTACT

+45 30 84 44 81; trineshow@bomi.roskilde.dk

Kirsten Krogh Jensen, MBA

CONTACT

+45 46 34 86 63; kirstenkj@bomi.roskilde.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 22, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 13, 2017

Record last verified: 2017-07