962 Participants Needed

BRILLIANT Platform for Brain Injury

Recruiting at 1 trial location
SA
Overseen BySara Ahmed, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Background: Cardiovascular and neurological conditions are major causes of disability worldwide. Early, intensive rehabilitation is essential but often challenging to access in current healthcare systems. In Canada, the direct and indirect costs of acquired brain injury (ABI) are substantial, emphasizing the need for improved rehabilitation services. In collaboration with four health regions and the Canadian Foundation of Innovation (CFI) funded BRILLIANT research group, we are implementing a digital health platform (the BRILLIANT platform), which includes five modules to address current gaps and support a person-centered integrated care continuum for cardiovascular and neurological conditions. In this stepped wedge randomized trial, we plan to implement and evaluate the use of the BRILLIANT Platform for improving transitions of care in the rehabilitation of ABI individuals in Quebec.Methods: A stepped wedge cluster randomized trial will be conducted across four healthcare regions with eight programs. Eligible participants included new cardiovascular and neurological patients, caregivers, clinicians, coordinators, and managers. The BRILLIANT platform intervention, implemented in 2 phases, will provide standardized assessments, communication tools, shared intervention plans, self-management support, and quality improvement dashboards. Outcomes will include rehabilitation intensity measured in minutes, time from admission to rehabilitation, health-related quality of life, care experience, and costs. Data analysis will use mixed-effects models for quantitative data and content analysis for qualitative data.Discussion: This study will provide valuable evidence on the effectiveness and feasibility of the BRILLIANT platform in improving rehabilitation care for patients with cardiovascular and neurological conditions in Quebec. We anticipate that by addressing the challenges and pursuing future directions, the implementation of this digital platform can contribute to improving patient outcomes and healthcare delivery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

How is the BRILLIANT Platform treatment unique for brain injury?

The BRILLIANT Platform treatment is unique because it leverages advanced data analysis and cloud-computing technologies to enhance understanding and treatment of brain injuries, unlike traditional methods that may not utilize such large-scale data-driven approaches.12345

What data supports the effectiveness of the BRILLIANT Platform treatment for brain injury?

The BRILLIANT Platform treatment may benefit from insights gained in neurorehabilitation, as seen in the use of Measurement Feedback Systems (MFS) that help track patient progress and tailor treatments for acquired brain injuries. Additionally, the development of personal smart technologies has shown promise in improving outcomes for adults with brain injuries, suggesting potential effectiveness for the BRILLIANT Platform.678910

Are You a Good Fit for This Trial?

This trial is for new patients with cardiovascular or neurological conditions, including stroke and traumatic brain injury, as well as their caregivers and healthcare providers in Quebec. It aims to improve rehabilitation care using the BRILLIANT digital platform.

Inclusion Criteria

Patients and caregivers must be able to provide informed consent to collect secondary outcomes (not needed for primary outcome, as identified administrative data will be provided by health regions)
Clinicians, coordinators, managers working in the 8 participating programs
Patients and caregivers must be able to speak and read English or French

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Implementation Preparation

Measuring and addressing potential barriers and facilitators related to the implementation of the BRILLIANT platform, including workflow reviews and focus groups.

2-7 months
Multiple focus group sessions

Phase II: Intervention and Evaluation

Evaluate the impact of the BRILLIANT platform on primary and secondary outcomes, including rehabilitation intensity and quality of life.

12-22 months
Regular assessments and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on long-term adoption and impact of the platform.

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • BRILLIANT Platform
Trial Overview The BRILLIANT Platform, an online tool with five modules designed to enhance care coordination and rehabilitation efforts, is being tested across four health regions. The study will measure its impact on rehab intensity, patient recovery timeframes, quality of life, care experiences, and costs.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Group I: Rehabilitation Program 8Experimental Treatment1 Intervention
Group II: Rehabilitation Program 7Experimental Treatment1 Intervention
Group III: Rehabilitation Program 6Experimental Treatment1 Intervention
Group IV: Rehabilitation Program 5Experimental Treatment1 Intervention
Group V: Rehabilitation Program 4Experimental Treatment1 Intervention
Group VI: Rehabilitation Program 3Experimental Treatment1 Intervention
Group VII: Rehabilitation Program 2Experimental Treatment1 Intervention
Group VIII: Rehabilitation Program 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Lead Sponsor

Trials
17
Recruited
3,400+

Citations

A systematic review of personal smart technologies used to improve outcomes in adults with acquired brain injuries. [2022]
Clinical trials in traumatic brain injury: cellular therapy and outcome measures. [2019]
Measurement Feedback System for Intensive Neurorehabilitation after Severe Acquired Brain Injury. [2022]
Head injury watch sheet modified for a digital scale. [2019]
Neuro-Link, a computer-assisted database for head injury in intensive care. [2019]
To the Cloud! A Grassroots Proposal to Accelerate Brain Science Discovery. [2021]
The Human Brain Project: Creating a European Research Infrastructure to Decode the Human Brain. [2017]
A National Network of Neurotechnology Centers for the BRAIN Initiative. [2018]
Power to the People: Addressing Big Data Challenges in Neuroscience by Creating a New Cadre of Citizen Neuroscientists. [2017]
Data warehousing methods and processing infrastructure for brain recovery research. [2021]
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