BRILLIANT Platform for Brain Injury

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new digital health platform, the BRILLIANT Platform, to enhance rehabilitation for people with brain injuries in Quebec. The platform includes tools for assessments, communication, and self-management to make rehabilitation more effective and user-friendly. The trial will evaluate whether this platform can improve patient care experiences and outcomes while reducing healthcare costs. Individuals with cardiovascular and neurological conditions, along with their caregivers who speak English or French, might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could transform rehabilitation practices.

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 prior data suggests that the BRILLIANT platform is safe for improving rehabilitation care?

Research has shown that digital health tools, like the BRILLIANT platform, are generally safe for use in rehabilitation. In a previous study, a similar virtual rehabilitation tool was tested and found safe and easy to use by patients with long-term health conditions. This finding suggests that patients generally receive digital platforms for rehabilitation well.

Specific safety data for the BRILLIANT platform is not yet available, but its "Not Applicable" trial phase suggests it is likely low-risk. This phase usually focuses on testing the treatment's effectiveness, as safety is typically assessed earlier.

Overall, existing evidence indicates that digital health platforms for rehabilitation are safe and can be used effectively by patients without major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BRILLIANT Platform for brain injury because it offers a new, intensive approach to rehabilitation that leverages digital health technology. Unlike traditional therapies that rely heavily on in-person sessions, this platform integrates a digital component, potentially offering more flexibility and personalized care. The platform aligns with international Acquired Brain Injury (ABI) guidelines, which means it could provide consistent and standardized care across different regions. By potentially enhancing the rehabilitation process with digital tools, the platform aims to improve patient outcomes more effectively compared to existing methods.

What evidence suggests that the BRILLIANT platform is effective for improving rehabilitation care for acquired brain injury?

Research shows that the BRILLIANT platform aims to make rehabilitation easier and more personalized for people with brain injuries. This trial will evaluate the BRILLIANT platform across various rehabilitation programs. Studies have found that digital health tools like BRILLIANT can improve patient care by enhancing communication and creating more customized treatment plans. Early evidence suggests this platform might help patients begin their rehabilitation sooner, ideally within 72 hours. Advanced technology in the platform monitors progress and adjusts care plans, potentially leading to better recovery outcomes. Overall, the BRILLIANT platform appears promising in supporting faster and more effective rehabilitation. ^{6 7 8 9 10}

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?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06867081

Study Details | NCT06867081 | Effectiveness of a ... This study will provide valuable evidence on the effectiveness and feasibility of the BRILLIANT platform in improving rehabilitation care for patients with ...

2. brilliant-cfi.ca brilliant-cfi.ca/pioneering-rehabilitation-the-brilliant-learning-communitys-journey/

The BRILLIANT Learning Community's Journey We will be able to learn from this data to find areas that can be improved like access to rehabilitation within 72 hours or addressing symptoms ...

3. clinconnect.io clinconnect.io/trials/NCT06867081

Effectiveness of a Customized Digital Platform to - ClinConnect This clinical trial is studying a new digital health platform called the BRILLIANT platform, which aims to improve the rehabilitation process for people ...

4. researchprotocols.org researchprotocols.org/2022/6/e12506/

Biomedical Research and Informatics Living Laboratory for ... Cognitive and functional outcomes following inpatient rehabilitation in patients with acquired brain injury: a prospective follow-up study.

5. researchgate.net researchgate.net/publication/358304429_Biomedical_Research_Informatics_Living_Laboratory_for_Innovative_Advances_of_New_Technologies_in_Community_Mobility_Rehabilitation_Protocol_for_a_longitudinal_evaluation_of_mobility_outcomes_Preprint

Biomedical Research & Informatics Living Laboratory for ... Theme 1 will implement and evaluate the feasibility of collecting data across BRILLIANT living labs and conduct predictive analyses and artificial intelligence ...

6. brilliant-cfi.ca brilliant-cfi.ca/category/news/

News Patient Perspectives in Focus: Enhancing SCI Care with PROMs Many factors determine the recovery outlook after Spinal Cord Injury (SCI), so it is important to…

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8492031/

Safety, Feasibility, and Acceptability of a New Virtual ... We performed a supervised pilot study to validate the safety, feasibility, and acceptability of a new virtual rehabilitation platform in patients with chronic ...

8. researchgate.net researchgate.net/publication/367089295_Inpatient_trial_of_a_tablet_app_for_communicating_brain_injury_rehabilitation_goals?_share=1

Inpatient trial of a tablet app for communicating brain injury ... Purpose: We examine the use of a custom iPad application, the Rehab Portal, to provide clients in an inpatient brain injury rehabilitation ...

9. delveinsight.com delveinsight.com/blog/wireless-brain-sensors-in-healthcare

Wireless Brain Sensors: Revolutionizing Neuroscience and ... Regulatory and Ethical Challenges: Non-invasive and semi-invasive wireless neural devices must meet stringent safety, data-handling, and ...

10. mdpi.com mdpi.com/2075-1729/15/3/424

Traumatic Brain Injury and Artificial Intelligence AI-driven algorithms have demonstrated high accuracy in predicting mortality, functional outcomes, and personalized rehabilitation strategies based on patient ...