Functional Evolution of Traumatic Brain Injured Adults During Rehabilitation and Social Participation

August 25, 2021 updated by: Michelle McKerral, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Functional Evolution of Traumatic Brain Injured Adults During Rehabilitation and Social Participation: a Continuum of Care to Community Study

The research project aims to better understand the multiple factors related to the clinical evolution and the social participation of traumatic brain injured (TBI). The project will provide better understanding of the patients' evolution during rehabilitation after TBI in terms of adaptation and social participation, assess the effect of rehabilitation and study social participation outcomes and quality of life of TBI patients one-year post-rehabilitation. Project benefits include improvement of clinical practices and support in decision-making.

The objectives of this research project are:

Part 1: To provide a picture of the evolution, in terms of social adaptation and participation of patients during rehabilitation after a TBI.

Part 2: To study social participation outcomes and quality of life of TBI individuals one year after the end of their rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Context: This clinical research project is part of a series of innovative approaches to knowledge transfer in the field of trauma care funded by the Institut national d'excellence en santé et en services sociaux (INESSS) that have been recently conducted by 5 rehabilitation centers and which laid the groundwork for a culture of systematic measurement of clinical and functional evolution during rehabilitation and of social participation outcomes of Quebec adults with a traumatic brain injury (TBI). The Mayo-Portland Adaptability Inventory-4, or MPAI-4, which has three short scales: Abilities (12 items), Adaptation (12 items), Participation (8 items) giving specific indexes to each of these three dimensions, as well as a total score reflecting the general level of adaptation/social participation, was implemented in all the TBI rehabilitation programs within the trauma care continuum of greater Montreal (5 rehabilitation sites). These new practices allow to carry out original and rigorous prospective studies in order to better understand the multiple factors related to the clinical evolution of individuals who have sustained a TBI.

Objectives: Objective 1- To provide a picture of the evolution, in terms of social adaptation/participation, of a multicenter patient cohort in rehabilitation following TBI, according to their rehabilitation pathway (inpatient-outpatient, outpatient only); Objective Objective 2- To study social participation outcomes and quality of life of TBI individuals one year after the end of their rehabilitation.

Methodology: MPAI-4 data will be obtained for all patients at start and end of rehabilitation, and they will be subsequently contacted by phone one year after the end of their rehabilitation to administer the MPAI-4 Participation scale and QOLIBRI, measuring quality of life. At the end of the project, at least 1,500 unique patient cases will have been integrated into the study. For the one-year post-rehabilitation follow-up of the subjects included in the database we estimate the loss at 30% maximum; we expect to be able to collect post-rehabilitation data from a minimum of 700 patients who have completed rehabilitation. The raw data will be subjected to quantitative statistical analyzes to meet different objectives: ANOVAs to compare start-to-end rehabilitation measurement times for the different rehabilitation pathways; ANCOVA to compare groups on the total score and the three MPAI-4 scales at the end of rehabilitation, with scores at rehabilitation start as covariates; ANCOVA to compare the two groups on the Participation scale and QOLIBRI at the one-year follow-up with scores at rehabilitation start as covariates. Regression analyses will also be performed to determine which sociodemographic and clinical variables are most closely related to MPAI-4 and QOLIBRI scores.

Expected impacts: This innovative study will provide an unprecedented portrait of social participation and clinical evolution during rehabilitation within the continuum of trauma care services for a large cohort of adults (young adults, middle-aged adults, seniors) who sustained a TBI. This will provide evidence that will improve practices and support decision-making related to the organization of services. The systematic use of MPAI-4 may also help to assess the effects of changes in rehabilitation practices (eg, when implementing TBI practice guidelines). The various actors involved in this project and who will form the Monitoring committee will ensure the multiple benefits and impacts of the project.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with a mild, moderate or severe TBI who are referred and registered in a multidisciplinary holistic rehabilitation program.

Description

Inclusion Criteria:

  • All adult TBI patients receiving post-acute rehabilitation services.

Exclusion Criteria:

  • TBI patients that do not complete at least one month of rehabilitation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TBI rehabilitation
All individuals with mild, moderate or severe TBI registered into rehabilitation.
Other: Usual gold-standard multidisciplinary rehabilitation for TBI
In individual and group interventions within a holistic interdisciplinary rehabilitation program focusing on resumption of daily activities and social roles. Interventions could include physiotherapy or physical training, occupational therapy, speech therapy, and neuropsychology/psychology, which aimed at reducing the impacts of cognitive difficulties in daily life by using self-guided and environmental strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from start of rehabilitation baseline (T0) Mayo-Portland Adaptability Inventory-4 (MPAI-4) at end of rehabilitation (post-intervention - T1)
Time Frame: Start to end of rehabilitation, an average of 1 year (pre-post rehabilitation - T0-T1)
The MPAI-4 has 29 scored items and each item is scored on a 5-point scale (from 0 to 4). There are three subscales: Abilities (12 scored items, 0-47 after adjusting scores), Adjustment (9 scored items, 0-46 after adjusting scores), Participation (8 scored items, 0-30 after adjusting scores) giving specific indexes to each of these three dimensions, as well as a total score (all 29 items, 0-111) reflecting the general level of adaptation/social participation. As three items contribute to both the Adjustment and the Participation scales, the total score is less than the sum of the three subscales. Higher scores mean worse outcome.
Start to end of rehabilitation, an average of 1 year (pre-post rehabilitation - T0-T1)
Change from end of rehabilitation (T1) Mayo-Portland Adaptability Inventory-4 (MPAI-4) at 1-year post-rehabilitation (follow-up -T2)
Time Frame: 1 year post-rehabilitation (post-rehabilitation to 1-year follow-up - T1-T2)
The MPAI-4 has 29 scored items and each item is scored on a 5-point scale (from 0 to 4). There are three subscales: Abilities (12 scored items, 0-47 after adjusting scores), Adjustment (9 scored items, 0-46 after adjusting scores), Participation (8 scored items, 0-30 after adjusting scores) giving specific indexes to each of these three dimensions, as well as a total score (all 29 items, 0-111) reflecting the general level of adaptation/social participation. As three items contribute to both the Adjustment and the Participation scales, the total score is less than the sum of the three subscales. Higher scores mean worse outcome.
1 year post-rehabilitation (post-rehabilitation to 1-year follow-up - T1-T2)
Quality of Life after Brain Injury (QOLIBRI) status at 1-year post-rehabilitation
Time Frame: 1-year post-rehabilitation (T2)
The MPAI-4 has 29 scored items and each item is scored on a 5-point scale (from 0 to 4). There are three subscales: Abilities (12 scored items, 0-47 after adjusting scores), Adjustment (9 scored items, 0-46 after adjusting scores), Participation (8 scored items, 0-30 after adjusting scores) giving specific indexes to each of these three dimensions, as well as a total score (all 29 items, 0-111) reflecting the general level of adaptation/social participation. As three items contribute to both the Adjustment and the Participation scales, the total score is less than the sum of the three subscales. Higher scores mean worse outcome.
1-year post-rehabilitation (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Collaborators

Fonds de la Recherche en Santé du Québec

Investigators

  • Principal Investigator: Michelle McKerral, PhD, CRIR-IURDPM-CCSMTL and Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRIR MMcK 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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