Pacing and Planning App for Traumatic Brain Injury

Overseen By Marquise Bonn, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: No concussion, Under 18, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 3 years

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Parkwood Pacing and Planning™ App, designed to help individuals who have had a concussion manage their daily activities and symptoms. The app employs a point system to guide users in planning their day, assisting them in balancing activities and avoiding overexertion. The goal is to improve recovery by simplifying the management of energy levels and symptoms. Individuals who have experienced a concussion and own a smartphone or tablet might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance concussion recovery strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Parkwood Pacing and Planning™ App is safe for users?

Research shows that both patients and doctors generally like the Parkwood Pacing and Planning™ app. Users find it helpful for managing post-concussion symptoms by planning daily activities. Studies have not reported specific safety concerns. The app employs a simple point system to help users balance activities according to symptom severity. Although direct information about negative effects is lacking, the app's non-invasive, self-management focus suggests it is likely safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parkwood Pacing and Planning™ App because it offers a novel approach to managing symptoms of traumatic brain injury. Unlike traditional treatments that might focus on medication or physical therapy, this app uses a points-based system to help individuals plan their daily activities based on energy levels and symptom management. By allotting points to tasks like grocery shopping or watching TV, patients learn to manage their energy more effectively, potentially leading to reduced symptoms and faster recovery times. This innovative strategy empowers patients to take control of their healing process in a personalized and structured way.

What evidence suggests that the Parkwood Pacing and Planning™ App is effective for managing symptoms of a concussion?

Research has shown that both patients and doctors have had positive experiences with the Parkwood Pacing and Planning™ app, the focus of this trial. This app assists people who have had a concussion in organizing their day by assigning points to activities based on energy requirements. By staying within a daily point limit, users can better manage symptoms and accelerate recovery. The app's point system helps users balance activities with rest. Early feedback indicates the app is effective for managing symptoms after a mild brain injury. ^{1 2 4 5 6}

Who Is on the Research Team?

Dalton Wolfe, PhD

Principal Investigator

Lawson Health Research Institiute

Are You a Good Fit for This Trial?

This trial is for adults who've had a mild traumatic brain injury or concussion, diagnosed by a healthcare professional. Participants must have access to a smartphone or tablet and be able to use English for reading and writing. It's not suitable for those without this type of injury, unwilling to share their diagnosis details, under 18, without device access, or unable to understand English.

Inclusion Criteria

I have had a mild concussion.

Disclosure of mechanism of injury and whether they were diagnosed with a mild traumatic brain injury/concussion by a registered health care practitioner

Access to a smartphone or tablet

Exclusion Criteria

You have not had a mild traumatic brain injury or concussion.

Inability to read, write, and understand English

No access to a smartphone or tablet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Parkwood Pacing and Planning™ app to manage daily activities and symptoms using a points system

Approximately 3 years

Bi-weekly virtual check-ins

Follow-up

Participants are monitored for changes in symptoms and general well-being after using the app

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Parkwood Pacing and Planning™ App

Trial Overview The Parkwood Pacing and Planning™ app is being tested. This app helps users manage symptoms after a concussion by assigning points for daily activities based on symptom severity. The study aims to enhance the app with personalized features using data analytics and machine learning.

How Is the Trial Designed?

Group I: Pacing and Planning App Experimental Treatment 1 Intervention

The Pacing and Planning Program is a points system to aid individuals with an acquired brain injury/concussion in planning daily activities and managing symptoms. Activities are allotted various points, depending on the energy the task requires and the symptoms they create. Activities can include anything from grocery shopping to driving or watching TV, etc. Patients are allotted a number of points for a day, and therefore learn to sparingly perform activities. This results in a reduction of symptoms and improved recovery time.

Parkwood Pacing and Planning™ App is already approved in Canada for the following indications:

Approved in Canada as MyBrainPacer™ for:

• Concussion symptom management
• Post-concussion syndrome management

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

St. Joseph's Health Care (SJHC) Foundation

Collaborator

Trials

1

Recruited

200+

Cowan Foundation

Collaborator

Trials

1

Recruited

200+

Published Research Related to This Trial

The Concussion or Brain Bleed app significantly increased patient knowledge about head injuries and CT use, with scores improving from an average of 3.3 to 4.7 correct answers out of 9 after using the app.

Clinicians found the app to be highly acceptable and helpful, with 85% reporting it was beneficial for patient understanding, and no patients experienced missed clinically important brain injuries within 7 days, indicating a safe approach to managing minor head injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tablet-Based Patient-Centered Decision Support for Minor Head Injury in the Emergency Department: Pilot Study. Singh, N., Hess, E., Guo, G., et al.[2019]

The Brain Fitness Center (BFC) at Walter Reed National Military Medical Center has provided brain-training programs to over 250 military Service Members, showing promising results in reducing cognitive and functional symptoms after traumatic brain injury, as indicated by significant improvements in the Mayo-Portland Adaptability Inventory and Neurobehavioral Symptom Inventory scores.

Preliminary data from the first 29 participants suggest that while there was a notable reduction in symptom severity, there were no significant changes in overall life satisfaction, highlighting the need for further research to fully understand the efficacy of computer-based cognitive rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes from a pilot study using computer-based rehabilitative tools in a military population. Sullivan, KW., Quinn, JE., Pramuka, M., et al.[2018]

RehaBot, a chatbot designed to support behavioral activation therapy for individuals with moderate to severe traumatic brain injury (TBI), showed promising usability and engagement, with participants exchanging an average of 225 messages over a week.

Preliminary results indicated that participants completed a higher proportion of planned activities during the RehaBot phase compared to the reversal phase, suggesting that the chatbot may enhance adherence to therapeutic activities through reminders and positive reinforcement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of RehaBot-A Conversational Agent for Promoting Rewarding Activities in Users With Traumatic Brain Injury. Rabinowitz, AR., Collier, G., Vaccaro, M., et al.[2022]

In a study involving 36 participants with brain injury from cerebrovascular accidents (CVA), the use of paging systems was effective in aiding memory and planning, similar to results seen in individuals with traumatic brain injury (TBI).

However, while TBI participants maintained the benefits of using the pager after treatment ended, CVA participants returned to baseline performance, suggesting that executive dysfunction may hinder the establishment of lasting routines from such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensatory strategies for acquired disorders of memory and planning: differential effects of a paging system for patients with brain injury of traumatic versus cerebrovascular aetiology. Fish, J., Manly, T., Emslie, H., et al.[2021]

A study involving 13 community-dwelling patients with traumatic brain injury showed that using smartphones with Internet-based calendars significantly reduced reported memory problems after a 6-week intervention, indicating their effectiveness as a memory aid.

While participants experienced fewer memory issues, the actual performance of target behaviors did not show significant improvement, suggesting that while smartphones can help with memory recall, they may not directly enhance the execution of tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective memory rehabilitation using smartphones in patients with TBI. Evald, L.[2018]

Out of 1296 mobile health apps examined for managing Traumatic Brain Injury (TBI), only 53 were included in the study, with most focusing on TBI screening, education, and monitoring, particularly for sports-related concussions.

The evidence supporting the effectiveness of these mHealth interventions is limited, with only eight relevant studies identified, indicating that while mHealth has potential, its current application in TBI management is not well-established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health for Traumatic Brain Injury: A Systematic Review of the Literature and Mobile Application Market. Christopher, E., Alsaffarini, KW., Jamjoom, AA.[2020]

The Porteus Maze Test (PMT) was administered to 276 children with traumatic brain injury (TBI) and showed high sensitivity to the severity of the injury and the volume of specific brain lesions, indicating its effectiveness in assessing planning abilities post-TBI.

In contrast, the Peabody Picture Vocabulary Test revealed that while vocabulary skills were affected by injury severity, they did not correlate with the presence of discrete prefrontal lesions, suggesting different cognitive mechanisms are impacted by TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Porteus Maze performance following traumatic brain injury in children. Levin, HS., Song, J., Ewing-Cobbs, L., et al.[2019]

The introduction of the patient locator and minder (PLAM) system significantly reduced the need for human prompts by over 50% for patients with acquired brain injury, indicating improved independence in therapy adherence.

The proportion of therapy sessions that required no prompting increased from 7% to 44% after using the PLAM system, demonstrating its effectiveness in helping patients reach their therapy destinations on their own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using talking lights to assist brain-injured patients with daily inpatient therapeutic schedule. Burke, DT., Leeb, SB., Hinman, RT., et al.[2019]

The Parkwood Pacing and Planning™ application received positive feedback from both patients and clinicians, with average ratings of 4.0 and 3.8 out of 5, indicating its potential effectiveness in helping individuals manage symptoms after mild traumatic brain injuries (mTBIs).

User experiences highlighted the need for improvements in the app's simplicity, adaptability, conciseness, and familiarity, suggesting that these modifications could enhance user satisfaction and overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability evaluation of a self-management mobile application for individuals with a mild traumatic brain injury. Bonn, MM., Graham, LJ., Marrocco, S., et al.[2023]

The SMART application, designed for youth recovering from mild traumatic brain injury (mTBI), received a high usability score of 85, indicating it is user-friendly and well-received by both children and parents.

User feedback led to improvements in the application, such as adding audio files to reduce reading demands, suggesting that the tool can be effectively tailored to enhance recovery strategies for mTBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability evaluation of the SMART application for youth with mTBI. Dexheimer, JW., Kurowski, BG., Anders, SH., et al.[2019]

Citations

1. r2pparkwood.ca r2pparkwood.ca/planning-and-pacing

Planning and Pacing The Parkwood Planning & Pacing Points App is an interactive electronic version of the planning and pacing points system currently being implemented in the ABI ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10327999/

Usability evaluation of a self-management mobile ... Preliminary analyses indicates patients and clinicians have a positive experience when using the Parkwood Pacing and Planning™ application. However, ...

3. clinicaltrial.be clinicaltrial.be/en/details/63579?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

The Parkwood Pacing and Planning™ App This program is renowned for its innovative programming, strong ties to brain injury research across the province, and the way that patients are ...

4. studies.bethecure.ca studies.bethecure.ca/find/bb4b8cd0fb90c3dd1e089206135e8808fb6d28ce-efficacy-of-the-pacing-and-planning-app-for-per

The Parkwood Pacing and Planning™ App - Find a Study In efforts to assist people who have had a concussion (mild traumatic brain injury), the Parkwood Pacing and Planning™ app has been developed and tested and ...

5. mybrainpacer.ca mybrainpacer.ca/app/eula

Application Disclaimer "MyBrainPacer™" is an application intended to help people manage their symptoms after a concussion or mild brain injury, when returning to everyday activities.

6. smartpatients.com smartpatients.com/trials/NCT03957343

The Parkwood Pacing and Planning™ App The app uses a point system where users have a daily point maximum assigned based on symptom severity with daily activities (recorded by the users).