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View on ClinicalTrials.gov

Testing Pacing and Planning App for acquired brain injury

Official title: The Parkwood Pacing and Planning™ App

Efficacy of the Pacing and Planning App for Persons With Mild Acquired Brain Injury

Condition: Acquired Brain InjurySponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sTarget enrollment: 200
  • 1 group
  • One site, in London
  • Recruiting
Parkwood Institute, London, Ontario

Interventions

  • Medical device

    Pacing and Planning App

    Participants will download and use the Pacing and Planning app through mybrainpacer.ca. The app will be used to track and monitor their daily tasks and symptoms at any time, for as long as they would like to use the app. While using the app, participants will also fill out short assessments, including the Rivermead Post-Concussion Questionnaire once a month (to monitor symptoms) and an overall symptom question once a week (to rate how they feeling in general from a lot better to a lot worse).

Canadian Sites (1)

1 of 1 recruiting

  • Parkwood Institute

    London, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for10 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Experienced a mild traumatic brain injury/concussion
  • +Disclosure of mechanism of injury and whether they were diagnosed with a mild traumatic brain injury/concussion by a registered health care practitioner
  • +18 yeas of age or older
  • +Access to a smartphone or tablet
  • +Able to read, write, and understand English

Exclusion

  • Did not experience a mild traumatic brain injury/concussion
  • Unwilling to disclose mechanism of injury and whether they were diagnosed with a mild traumatic brain injury/concussion
  • Under 18 years of age
  • No access to a smartphone or tablet
  • Inability to read, write, and understand English
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to improve comfort and quality of life alongside other care.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

Everyone in this study is in one group and receives Pacing and Planning App.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 200 people.

The study is currently expected to finish around December 2026.

The main measurement is taken over: Approximately 3 years.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Symptom changes — measured over Approximately 3 years.

Changes in general well-being — measured over Approximately 3 years.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT03957343 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Pacing and Planning AppDevice

Participants will download and use the Pacing and Planning app through mybrainpacer.ca. The app will be used to track and monitor their daily tasks and symptoms at any time, for as long as they would like to use the app. While using the app, participants will also fill out short assessments, including the Rivermead Post-Concussion Questionnaire once a month (to monitor symptoms) and an overall symptom question once a week (to rate how they feeling in general from a lot better to a lot worse).

From the trial registry — its own words, unedited.

What a device is here: A physical instrument, implant, app or piece of equipment being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Approximately 3 years.

The study as a whole is currently expected to finish around 2026-12.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 200 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: London, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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 will be released to the public. 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). Users can then schedule their daily activities based on their allowed points. The goal is to help users with symptom self-management by facilitating activity planning and pacing. Patients and clinicians have provided positive feedback on the initial version of the app. Using this as a foundation, the investigators envision enhancing the app to provide a more personalized user experience and to enable further discovery and innovations in the recovery from concussion. This will be accomplished through data analytics and machine-learning techniques, informed by the results of a large-scale research trial. This strategy will be used to customize the point system to facilitate the user with pacing and planning.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.