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

Trial Summary

What is the purpose of this trial?

This trial tests the MyBrainPacer™ app, which helps people with post-concussion syndrome manage their daily activities using a point system. The app assigns points to activities based on how much energy they require and how severe the symptoms they might trigger. This helps users avoid overexertion and manage their symptoms more effectively.

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 data supports the effectiveness of the treatment Pacing and Planning App for Traumatic Brain Injury?

There is some evidence that mobile health applications can help manage symptoms after a traumatic brain injury, but the overall evidence for their effectiveness is limited. Similar tools, like paging systems, have been shown to help with memory and planning issues in brain injury patients. ^{1 2 3 4 5}

Is the Pacing and Planning App safe for use in humans?

The Parkwood Pacing and Planning™ application was evaluated for user experiences and perceptions, but there is no specific safety data mentioned in the available research. ^{1 6 7 8 9}

How is the Parkwood Pacing and Planning™ App treatment different from other treatments for traumatic brain injury?

The Parkwood Pacing and Planning™ App is unique because it is a mobile health application specifically designed to help individuals with traumatic brain injury manage their symptoms through pacing and planning strategies, which are not commonly addressed by other treatments. This app provides a self-management tool that enhances access to rehabilitation and supports users in organizing their daily activities, which is different from traditional therapies that may not focus on these aspects. ^{1 2 4 5 10}

Research Team

Dalton Wolfe, PhD

Principal Investigator

Lawson Health Research Institiute

Eligibility Criteria

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 am 18 years old or older.

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

Exclusion Criteria

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

Inability to read, write, and understand English

I am younger than 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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 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]

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]

References

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

Usability evaluation of a self-management mobile application for individuals with a mild traumatic brain injury. [2023]

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

Using talking lights to assist brain-injured patients with daily inpatient therapeutic schedule. [2019]

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

Development of RehaBot-A Conversational Agent for Promoting Rewarding Activities in Users With Traumatic Brain Injury. [2022]

4. England 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. [2021]

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

Mobile Health for Traumatic Brain Injury: A Systematic Review of the Literature and Mobile Application Market. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Tablet-Based Patient-Centered Decision Support for Minor Head Injury in the Emergency Department: Pilot Study. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes from a pilot study using computer-based rehabilitative tools in a military population. [2018]

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

Porteus Maze performance following traumatic brain injury in children. [2019]

9. Ireland pubmed.ncbi.nlm.nih.gov

Usability evaluation of the SMART application for youth with mTBI. [2019]

10. England pubmed.ncbi.nlm.nih.gov

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