Clinical trial NCT05022940: Functional Evolution of Traumatic Brain Injured Adults During Rehabilitation and Social Participation
Official title: Functional Evolution of Traumatic Brain Injured Adults During Rehabilitation and Social Participation: a Continuum of Care to Community Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: Social participation
Quality of life
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2021-08-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from start of rehabilitation baseline (T0) Mayo-Portland Adaptability Inventory-4 (MPAI-4) at end of rehabilitation (post-intervention - T1)
timeFrame: Start to end of rehabilitation, an average of 1 year (pre-post rehabilitation - T0-T1)
measure: Change from end of rehabilitation (T1) Mayo-Portland Adaptability Inventory-4 (MPAI-4) at 1-year post-rehabilitation (follow-up -T2)
timeFrame: 1 year post-rehabilitation (post-rehabilitation to 1-year follow-up - T1-T2)
measure: Quality of Life after Brain Injury (QOLIBRI) status at 1-year post-rehabilitation
timeFrame: 1-year post-rehabilitation (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CRIR
state: Quebec
Study officials:
affiliation: CRIR-IURDPM-CCSMTL and Université de Montréal
name: Michelle McKerral, PhD
role: PRINCIPAL_INVESTIGATOR
References: