mHealth Technology in the Treatment of Post-concussion Symptoms (PERSIST)

The Utilization of mHealth Technology to Improve the Treatment and Recovery of Post-concussion Symptoms: A Pilot Randomized Controlled Trial

Patients with concussion symptoms are asked by their doctors to stretch, exercise, and practice mindfulness daily. Patients can have a hard time sticking to these activities, which can cause patients to feel symptoms for longer than if they stuck to the doctor's suggestions. Many areas of medicine are now using mobile health (mHealth) technology, such as phone applications, to help patients with their treatment plans. No study has looked at the use of phone applications in general population adults with a concussion. This study will look at patient symptoms, quality of life, and satisfaction with care between two groups of patients. Patients will be randomly placed into either the group that gets standard care or the group that will use the smartphone application. The investigators will compare changes in symptoms and quality of life, as well as satisfaction with care, 1 and 3 months after the patient's first visit with their doctor. The investigators hope this study helps to guide the use of mHealth technology in the treatment of post-concussion symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Concussion Syndrome
• Intervention / Treatment: Other: MyHeadHealth online application; Other: Standard of Care

Detailed Description

The proper development of mHealth technology requires the completion of 5 phases as outlined by The Center for eHealth Research and Disease Management. Dr. Perera and his research team have accomplished the first three stages (contextual inquiry, value specification and design); the proposed study will support the completion of phase four (operationalization - the integration of the application into practice) and five (summative evaluation). Using the proposed randomized controlled trial, the investigators will evaluate the use of MyHeadHealth in the rehabilitation of PCS as compared to SOC. While research on the integration of mHealth technology in other health specialties has been beneficial for diagnostic and clinical decision making, behavior change, digital therapeutics and delivering educational content to patients,18 there is a paucity of research in PCS. To properly evaluate the use of mHealth technology in the rehabilitation of PCS, a methodologically robust study directly comparing this new technology to SOC is required. The purpose of this study is to explore the clinical use of MyHeadHealth to treat adult PCS patients. The primary objective of this study is to determine if MyHeadHealth significantly improves patient symptomology when compared to standard of care (SOC). The secondary objective of this study is to understand if MyHeadHealth has a significant effect on treatment compliance, QOL and satisfaction with care as compared to SOC. A sub-group analysis within this study will explore the relationship between self-efficacy and treatment compliance in adult PCS patients.

Patients will be introduced to the study during their consultation with Dr. Perera; if interested, the patient will speak to a research team member and consent to participate. Following consent they will be randomized into their study group and complete the baseline questionnaires. Patients will complete treatment as outlined by their physician. They will be contacted to complete questionnaires at 1 and 3 months following their consultation. Communication will occur via email or mail, depending on how the patient wished to be contacted.

The primary outcome of this study is symptomology. The secondary outcome measures are quality of life, satisfaction with care, self efficacy and treatment compliance.

Data analysis will focus on how the use of MyHeadHealth impacted patient compliance and concomitantly, how that impacted symptoms, quality of life and satisfaction with care. The investigators will also look at the difference in self-efficacy between groups and how that impacted the outcome measures. Within group analyses will also be performed to understand changes within the control and intervention group.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Murphy, PhD; Phone Number: 905-536-9612; Email: murphj11@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinician diagnosis of a subconcussive injury or a concussion consistent with the 2017 Berlin Consensus Statement
• Capable of providing consent
• Able to complete study questionnaires
• Fluent in English
• A Glasgow Coma Scale (GCS) score of ≥14
• Has a cellular device that has access to the internet (so they can access MyHeadHealth)

Exclusion Criteria:

• Moderate (GCS 9-13) or Severe (GCS 3-8) Traumatic Brain Injury
• Patients with light sensitivities that prevent looking at devise for longer than 10 minutes
• Patients with a cognitive, physical, or emotional impairment that would prevent them from being able to perform a self-directed program or use the MyHeadHealth app

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Patients in the control group will receive standard of care for the treatment of post-concussion symptoms at our Integrated Adult Concussion Clinic	Other: Standard of Care; Patients will receive Standard of Care from our concussion clinic as necessary as per the consultation with the physician
Experimental: mHealth; Patients in the intervention group will use MyHeadHealth - an online application to help in the completion of their treatment plan	Other: MyHeadHealth online application; MyHeadHealth is an online application to be accessed through the patients smartphone. The goal of MyHeadHealth is to improve treatment compliance by providing patients with free and convenient access to resources and activities that align with their treatment plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurobehavioral Symptoms Inventory	Measures common symptoms presenting in post-concussion patients- The total scores range from 0-88, with a high score indicative of worse post-concussive symptoms	Baseline (at consult)
Neurobehavioral Symptoms Inventory	Measures common symptoms presenting in post-concussion patients -The total scores range from 0-88, with a high score indicative of worse post-concussive symptoms	1 Month post consult
Neurobehavioral Symptoms Inventory	Measures common symptoms presenting in post-concussion patients -The total scores range from 0-88, with a high score indicative of worse post-concussive symptoms	3 Months post consult

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Quality-of-Life (AQoL) Scale	Measures patient quality of life (physical, emotional and mental) - total score out of 100 - Higher scores represent worsening psychosocial well-being and physical pain	Baseline (at consult)
Assessment of Quality-of-Life (AQoL) Scale	Measures patient quality of life (physical, emotional and mental) - total score out of 100 - Higher scores represent worsening psychosocial well-being and physical pain	1 month post consult
Assessment of Quality-of-Life (AQoL) Scale	Measures patient quality of life (physical, emotional and mental) - total score out of 100 - Higher scores represent worsening psychosocial well-being and physical pain	3 months post consult
Short Assessment of Patient Satisfaction Measure	Measures Patient Satisfaction with Care - score is totaled with higher scores (maximum of 28) indicating higher levels of satisfaction	Baseline (consult)
Short Assessment of Patient Satisfaction Measure	Measures Patient Satisfaction with Care - score is totaled with higher scores (maximum of 28) indicating higher levels of satisfaction	1 month post consult
Short Assessment of Patient Satisfaction Measure	Measures Patient Satisfaction with Care -score is totaled with higher scores (maximum of 28) indicating higher levels of satisfaction	3 months post consult
Adapted version of the Morisky Adherence Scale (MMAS-8)	Measures patient compliance to treatment plan. Scoring is done by summing questions 1 - 7 and then dividing the score for question 8 by 4 and adding it to the sum of 1-7. High adherence is a score of 8; medium is a score of 6 or 7; low is a score less than 6.	1 month (post consult)
Adapted version of the Morisky Adherence Scale (MMAS-8)	Measures patient compliance to treatment plan. Scoring is done by summing questions 1 - 7 and then dividing the score for question 8 by 4 and adding it to the sum of 1-7. High adherence is a score of 8; medium is a score of 6 or 7; low is a score less than 6.	3 months (post consult)
MyHeadHealth tracker	Measures patient compliance to treatment plan, headache and sleep quality in patients - randomized to the intervention group - this is not a scale, it is a "bubble sheet" format, where patients fill in a bubble to indicate level of headache, quality of sleep, and compliance to treatment plan	1 month (post consult)
MyHeadHealth tracker	Measures patient compliance to treatment plan, headache and sleep quality in patients randomized to the intervention group - this is not a scale, it is a "bubble sheet" format, where patients fill in a bubble to indicate level of headache, quality of sleep, and compliance to treatment plan	3 months (post consult)
Self-Efficacy for Home Exercise Program Scale (SEHEPS)	Patient Self-Efficacy for Treatment Compliance - a 12-item questionnaire designed to assess perceived self-efficacy for a prescribed home-based exercise plan. For the purposes of this study, the term "exercise plan" was changed to "prescribed treatment plan". Patients answer the questions on a 7-point scale that ranged from 0 (not confident) to 6 (very confident). Total scores ranged from 0 (low self-efficacy) to 72 (high self-efficacy).	Baseline (consult)
Self-Efficacy for Home Exercise Program Scale (SEHEPS)	Patient Self-Efficacy for Treatment Compliance - a 12-item questionnaire designed to assess perceived self-efficacy for a prescribed home-based exercise plan. For the purposes of this study, the term "exercise plan" was changed to "prescribed treatment plan". Patients answer the questions on a 7-point scale that ranged from 0 (not confident) to 6 (very confident). Total scores ranged from 0 (low self-efficacy) to 72 (high self-efficacy).	1 month (post consult)
Self-Efficacy for Home Exercise Program Scale (SEHEPS)	Patient Self-Efficacy for Treatment Compliance - a 12-item questionnaire designed to assess perceived self-efficacy for a prescribed home-based exercise plan. For the purposes of this study, the term "exercise plan" was changed to "prescribed treatment plan". Patients answer the questions on a 7-point scale that ranged from 0 (not confident) to 6 (very confident). Total scores ranged from 0 (low self-efficacy) to 72 (high self-efficacy).	3 months (post consult)

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Gihan Perera, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2024
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Post-Concussion Syndrome
• Other Study ID Numbers: 16252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to make patient data available to other researchers to protect the identity of our patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No