Evidence map›Paper›PMID 28793916›Full record

Trial reportTrials2017

A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT).

Louise K Hoeffding, Maria Haahr Nielsen, Morten A Rasmussen, Anne Norup, Juan Carlos Arango-Lasprilla, Ulrikka K Kjær, Kristoffer Sølvsten Burgdorf, Kirsten Jensen Quas, Trine Schow

Erratum issued Registry-linked trialOpen access · goldAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03086031 (A Randomised Controlled Trial of a Manual-Based Vocational Rehabilitation Program for Patients With Acquired Brain Injury), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03086031 naunknown statusnot on this map

A Randomised Controlled Trial of a Manual-Based Vocational Rehabilitation Program for Patients With Acquired Brain Injury

TypeinterventionalSponsorBrain Injury Center BOMI, Roskilde, DenmarkRan2017 to 2019Enrolled84ConditionsBrain InjuriesArmsProgram -based vocational rehabilitation intervention, Conventional vocational rehabilitation (controls)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Emotional distress in neuro-ICU survivor-caregiver dyads: The recovering together randomized clinical trial.Health psychology : official journal of the Division of Health Psychology, American Psychological Association · 2022
    Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 2 countries.

Louise K HoeffdingResearch and development, Brain Injury Center BOMI, Maglegaardsvej 15, 4000, Roskilde, Denmark.
Maria Haahr NielsenResearch and development, Brain Injury Center BOMI, Maglegaardsvej 15, 4000, Roskilde, Denmark.
Morten A RasmussenFaculty of Science, Chemometrics and Analytical Technology, University of Copenhagen, Copenhagen, Denmark.
Anne NorupNational Study on Young Brain Injury Survivors, Department of Neurology, Rigshospitalet-Copenhagen University Hospital, Copenhagen, Denmark.
Juan Carlos Arango-LasprillaBioCruces Health Research Institute, Cruces University Hospital, Barakaldo, Spain.
Ulrikka K KjærKjaer Management, 3520, Farum, Denmark.
Kristoffer Sølvsten BurgdorfResearch and development, Brain Injury Center BOMI, Maglegaardsvej 15, 4000, Roskilde, Denmark.
Kirsten Jensen QuasNeuropsychologist, Head of Research and Development at Brain Injury Center BOMI, Roskilde, Denmark.
Trine SchowResearch and development, Brain Injury Center BOMI, Maglegaardsvej 15, 4000, Roskilde, Denmark. Trineschow@bomi.roskilde.dk.ORCID 0000-0002-5787-4265
Copenhagen University Hospital · DKRigshospitalet · DKIkerbasque · ESMoesgaard Museum · DKRoskilde University · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn 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. Therefore, the aim of this study is to evaluate the effect of an individually targeted manual-based VR for patient with ABI compared to conventional VR (usual care).

methodsThis study is an interventional, two-arm, six-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 six- to nine-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 six-month follow-up. Moreover, a budget impact analysis and possibly a cost-utility analysis of the intervention will be performed. DISCUSSION: This study consists of a comprehensive multidiciplinary VR intervention involving several 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. Furthermore, the study will contribute with novel knowledge regarding feasibility and clinical effectiveness of the VR intervention relevant to clinicians, researchers, and policymakers.

trial registrationClinicalTrials.gov, NCT03086031 . Registered on 21 March 2017.

Indexed as

AdolescentAdultBrain InjuriesBudgetsCaregiversClinical ProtocolsCost-Benefit AnalysisDenmarkEmployment, SupportedFamily TherapyFemaleHealth Care CostsHumansMaleMiddle AgedNew ZealandCaregiver interventionRandomized controlled trialsReturn to workStudy protocolTraumatic brain injuryVocational rehabilitation

Identifiers

PMID28793916
PMCPMC5550982
OpenAlexW2744449747

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.