The Parkwood Pacing and Planning™ App

NCT ID: NCT03957343

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

At Parkwood Institute, the Outpatient Acquired Brain Injury Program receives approximately 350 referrals per year related to concussion (an increase of 500% since 2010). This program is renowned for its innovative programming, strong ties to brain injury research across the province, and the way that patients are engaged in program design, development and evaluation.

People who experience persistent and disabling problems three months beyond their brain injury are characterized as having "post-concussion syndrome". The list of post-concussion symptoms is long. Some of the most prevalent and debilitating symptoms include severe headaches and fatigue, forgetfulness, blurred vision and dizziness resulting in balance difficulties, poor concentration, sleep disturbances and depression. These symptoms can impact someone's daily functional ability, cause emotional distress and potentially limit their ability to return to work or school, which includes early back to work employment. Further, the impact of these debilitating symptoms can result in the breakdown of the family unit; whereby the patient's recovery is put at risk along with the mental health and financial impact on their family.

While trying to cope with these persistent symptoms, many individuals also experience a lack of post-recovery education and ongoing daily support as to how best to manage their symptoms while they begin to recover. Resting can actually prolong symptoms and lead to more difficulties, while being too active can restart or increase the severity of symptoms. However, health care providers at Parkwood Institute have discovered that patients who learn how to appropriately pace and plan their activities can minimize their symptoms, enhance recovery, and resume activities that had previously been a major part of their lives.

In 2013, the Parkwood Institute Outpatient Acquired Brain Injury Team developed a paper-based pacing and planning points system with a scale for rating the difficulty of daily activities (like grocery shopping, driving, and reading) according to the amount of energy each requires, and the severity of symptoms they trigger.

By tracking the maximum number of points they can comfortably expend in a day, patients learned how to self-manage their symptoms and improve participation in daily activities. In using this system, patients found they were able to reduce the severity and frequency with which symptoms occurred. A former outpatient said, "the points plan was such an effective way for me to get through the day without being utterly exhausted. I continue to use it as it has made me more independent, and as such, less reliant on my support people." In efforts to make this system more user-friendly and readily available for more patients, the investigators have created a mobile version of this planning and pacing points system, "MyBrainPacer™". Preliminary usability testing has indicated user and clinician satisfaction with the app.

For this next stage of development, the investigators plan to conduct a large-scale evaluation trial to demonstrate the effectiveness of the app more fulsomely. Completing this process will not only provide evidence related to the effectiveness of the app, but will also generate data to inform an existing gap in scientific literature: understanding of concussion recovery patterns. Analysis of the data will facilitate a better understanding of the patterns that exist between symptoms and everyday activity. In turn, this will enable development of a more personalized and customized version of the app, where the app 'learns' the patterns of a particular person and tailors their point system to their specific needs.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acquired Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pacing and Planning App

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.

Group Type EXPERIMENTAL

Pacing and Planning App

Intervention Type DEVICE

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Experienced a mild traumatic brain injury/concussion
2. Disclosure of mechanism of injury and whether they were diagnosed with a mild traumatic brain injury/concussion by a registered health care practitioner
3. 18 yeas of age or older
4. Access to a smartphone or tablet
5. Able to read, write, and understand English

Exclusion Criteria

1. Did not experience a mild traumatic brain injury/concussion
2. Unwilling to disclose mechanism of injury and whether they were diagnosed with a mild traumatic brain injury/concussion
3. Under 18 years of age
4. No access to a smartphone or tablet
5. Inability to read, write, and understand English
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Joseph's Health Care (SJHC) Foundation

UNKNOWN

Sponsor Role collaborator

Cowan Foundation

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dalton Wolfe, PhD

Role: PRINCIPAL_INVESTIGATOR

Lawson Health Research Institiute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Parkwood Institute

London, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dalton Wolfe, PhD

Role: CONTACT

5196854292 ext. 42957

Marquise Bonn, MSc

Role: CONTACT

5196854292 ext. 42796

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dalton Wolfe, PhD

Role: primary

519-646-6100 ext. 42957

References

Explore related publications, articles, or registry entries linked to this study.

Savola O, Hillbom M. Early predictors of post-concussion symptoms in patients with mild head injury. Eur J Neurol. 2003 Mar;10(2):175-81. doi: 10.1046/j.1468-1331.2003.00552.x.

Reference Type BACKGROUND
PMID: 12603294 (View on PubMed)

Schneider KJ, Leddy JJ, Guskiewicz KM, Seifert T, McCrea M, Silverberg ND, Feddermann-Demont N, Iverson GL, Hayden A, Makdissi M. Rest and treatment/rehabilitation following sport-related concussion: a systematic review. Br J Sports Med. 2017 Jun;51(12):930-934. doi: 10.1136/bjsports-2016-097475. Epub 2017 Mar 24.

Reference Type BACKGROUND
PMID: 28341726 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

113428

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.