BRILLIANT Platform for Brain Injury

Recruiting at 1 trial location

Overseen By Sara Ahmed, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

962 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Rehabilitation Program 8 Experimental Treatment 1 Intervention

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Group II: Rehabilitation Program 7 Experimental Treatment 1 Intervention

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Group III: Rehabilitation Program 6 Experimental Treatment 1 Intervention

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Group IV: Rehabilitation Program 5 Experimental Treatment 1 Intervention

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Group V: Rehabilitation Program 4 Experimental Treatment 1 Intervention

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Group VI: Rehabilitation Program 3 Experimental Treatment 1 Intervention

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Group VII: Rehabilitation Program 2 Experimental Treatment 1 Intervention

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Group VIII: Rehabilitation Program 1 Experimental Treatment 1 Intervention

The program provides intensive rehabilitation following ABI guidelines and in line with other provinces and countries. There is a period when outcomes are collected during an initial control period (2 to 7 months depending on when the program is randomized to receive the intervention), followed by an intervention period when the digital health platform is deployed (12 months to 22 months depending on when the program is randomized).

Who Is Running the Clinical Trial?

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Lead Sponsor

Trials

17

Recruited

3,400+

References

1. England pubmed.ncbi.nlm.nih.gov

A systematic review of personal smart technologies used to improve outcomes in adults with acquired brain injuries. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical trials in traumatic brain injury: cellular therapy and outcome measures. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Measurement Feedback System for Intensive Neurorehabilitation after Severe Acquired Brain Injury. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Head injury watch sheet modified for a digital scale. [2019]

5. Austria pubmed.ncbi.nlm.nih.gov

Neuro-Link, a computer-assisted database for head injury in intensive care. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

To the Cloud! A Grassroots Proposal to Accelerate Brain Science Discovery. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Human Brain Project: Creating a European Research Infrastructure to Decode the Human Brain. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

A National Network of Neurotechnology Centers for the BRAIN Initiative. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Power to the People: Addressing Big Data Challenges in Neuroscience by Creating a New Cadre of Citizen Neuroscientists. [2017]

10. Italy pubmed.ncbi.nlm.nih.gov

Data warehousing methods and processing infrastructure for brain recovery research. [2021]