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

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

Interventions

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).

BEHAVIORAL

Conventional vocational rehabilitation (controls)

Treatment as usual delivered by the municipalities.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Hospital de Cruces

  collaborator OTHER

• Brain Injury Center BOMI, Roskilde, Denmark

  lead OTHER

Principal Investigators

• Kirsten krogh Jensen, MBA · Brain Injury Center BOMI

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-31

Primary Completion

2019-12-31

Completion

2019-12-31