Clinical trial NCT05848193: mHealth Technology in the Treatment of Post-concussion Symptoms
Official title: The Utilization of mHealth Technology to Improve the Treatment and Recovery of Post-concussion Symptoms: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Concussion Syndrome
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurobehavioral Symptoms Inventory
timeFrame: Baseline (at consult)
measure: Neurobehavioral Symptoms Inventory
timeFrame: 1 Month post consult
measure: Neurobehavioral Symptoms Inventory
timeFrame: 3 Months post consult
Secondary outcomes:
measure: Assessment of Quality-of-Life (AQoL) Scale
timeFrame: Baseline (at consult)
measure: Assessment of Quality-of-Life (AQoL) Scale
timeFrame: 1 month post consult
measure: Assessment of Quality-of-Life (AQoL) Scale
timeFrame: 3 months post consult
measure: Short Assessment of Patient Satisfaction Measure
timeFrame: Baseline (consult)
measure: Short Assessment of Patient Satisfaction Measure
timeFrame: 1 month post consult
measure: Short Assessment of Patient Satisfaction Measure
timeFrame: 3 months post consult
measure: Adapted version of the Morisky Adherence Scale (MMAS-8)
timeFrame: 1 month (post consult)
measure: Adapted version of the Morisky Adherence Scale (MMAS-8)
timeFrame: 3 months (post consult)
measure: MyHeadHealth tracker
timeFrame: 1 month (post consult)
measure: MyHeadHealth tracker
timeFrame: 3 months (post consult)
measure: Self-Efficacy for Home Exercise Program Scale (SEHEPS)
timeFrame: Baseline (consult)
measure: Self-Efficacy for Home Exercise Program Scale (SEHEPS)
timeFrame: 1 month (post consult)
measure: Self-Efficacy for Home Exercise Program Scale (SEHEPS)
timeFrame: 3 months (post consult)
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Gihan Perera, MD
role: PRINCIPAL_INVESTIGATOR
References: