Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05022940 |
| Other study ID # |
CRIR MMcK 2 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2017 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
August 2021 |
| Source |
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal |
| Contact |
CRIR IURDPM-CCSMTL |
| Phone |
(514) 340-2085 Ext. 4778 |
| Email |
administration.crir[@]ssss.gouv.qc.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
