The Parkwood Pacing and Planning™ App

NCT03957343 | Recruiting

• 1 other identifier: 113428
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acquired Brain Injury

Keywords

acquired brain injury; concussion

Outcome Measures

Primary Outcomes (2)

• Symptom changes

  These are assessed using the Rivermead Post Concussion Questionnaire (RPQ). The RPQ evaluates the severity of 16 common post-concussion symptoms over the past 24 hours (e.g. headache, sleep disturbance, and noise sensitivity). It is a 5-point scale from 0-4, where 0 indicates no symptoms (better outcome), and 4 indicates the symptom is a severe problem (worse outcome). The total from each symptom can be summed for a total score out of 64, where 64 represents experiencing all symptoms, and they are all a severe problem (worse outcome). This will contribute to understanding the effectiveness of the app.

  Approximately 3 years

• Changes in general well-being

  This will be assessed using the responses to one bi-weekly question. The bi-weekly question asks how users are feeling, and they can choose to answer with much worse, worse, the same, better, or much better. This will contribute to understanding the effectiveness of the app.

  Approximately 3 years

Secondary Outcomes (1)

• Change in daily activities and symptoms

  Approximately 3 years

Study Arms (1)

Pacing and Planning App

EXPERIMENTAL

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.

Device: Pacing and Planning App

Interventions

Pacing and Planning App 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).

Pacing and Planning App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• yeas of age or older
• Access to a smartphone or tablet
• Able to read, write, and understand English

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• St. Joseph's Health Care (SJHC) Foundation: collaborator
• Cowan Foundation: collaborator

Study Sites (1)

Parkwood Institute

London, Ontario, N6C 5J1, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 12603294 BACKGROUND

• 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.

  PMID: 28341726 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries, Traumatic; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Dalton Wolfe, PhD

  Lawson Health Research Institiute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalton Wolfe, PhD

CONTACT

5196854292; dwolfe@uwo.ca

Marquise Bonn, MSc

CONTACT

5196854292; mmayo23@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)