mHealth Technology in the Treatment of Post-concussion Symptoms

NCT05848193 | Not Yet Recruiting

• 1 other identifier: 16252
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post Concussion Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Assessment of Quality-of-Life (AQoL) Scale

  Baseline (at consult)

• Assessment of Quality-of-Life (AQoL) Scale

  1 month post consult

• Assessment of Quality-of-Life (AQoL) Scale

  3 months post consult

• Short Assessment of Patient Satisfaction Measure

  Baseline (consult)

• Short Assessment of Patient Satisfaction Measure

  1 month post consult

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

mHealth

EXPERIMENTAL

Patients in the intervention group will use MyHeadHealth - an online application to help in the completion of their treatment plan

Other: MyHeadHealth online application

Interventions

MyHeadHealth online application OTHER

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

mHealth

Standard of Care OTHER

Patients will receive Standard of Care from our concussion clinic as necessary as per the consultation with the physician

Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Post-Concussion Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gihan Perera, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Murphy, PhD

CONTACT

905-536-9612; murphj11@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 8, 2023
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share