Post Concussion SyndromePERSISTNCT05848193
mHealth Technology in the Treatment of Post-concussion Symptoms
A study testing MyHeadHealth online application in people with Post Concussion Syndrome, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Concussion Syndrome
- What is being tested?
- MyHeadHealth online application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Concussion Syndrome
- Being tested
- MyHeadHealth online application, Standard of Care
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyHeadHealth online applicationOther
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
Standard of CareOther
Patients will receive Standard of Care from our concussion clinic as necessary as per the consultation with the physician
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: MyHeadHealth online application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 Months post consult
Secondary outcomes (13)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3 months (post consult)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gihan Perera, McMaster University
- Investigators
- Gihan Perera, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848193
- Sponsor's protocol ID
- 16252
- Acronym
- PERSIST
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make patient data available to other researchers to protect the identity of our patients
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of mHealth Technology to Improve the Treatment and Recovery of Post-concussion Symptoms: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05848193
- Acronym / sponsor ID
- PERSIST / 16252
- Conditions
- Post Concussion Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CarePatients in the control group will receive standard of care for the treatment of post-concussion symptoms at our Integrated Adult Concussion Clinic |
| mHealth | Experimental | Other: MyHeadHealth online applicationPatients in the intervention group will use MyHeadHealth - an online application to help in the completion of their treatment plan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyHeadHealth online applicationMyHeadHealth 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 | Other | mHealth |
| Standard of CarePatients will receive Standard of Care from our concussion clinic as necessary as per the consultation with the physician | Other | Standard of Care |
Primary outcome
Neurobehavioral Symptoms Inventory
Time frame: Baseline (at consult)
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
Neurobehavioral Symptoms Inventory
Time frame: 1 Month post consult
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
Neurobehavioral Symptoms Inventory
Time frame: 3 Months post consult
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
13 secondary outcomes
Assessment of Quality-of-Life (AQoL) Scale
Time frame: Baseline (at consult)
Assessment of Quality-of-Life (AQoL) Scale
Time frame: 1 month post consult
Assessment of Quality-of-Life (AQoL) Scale
Time frame: 3 months post consult
Short Assessment of Patient Satisfaction Measure
Time frame: Baseline (consult)
Short Assessment of Patient Satisfaction Measure
Time frame: 1 month post consult
Short Assessment of Patient Satisfaction Measure
Time frame: 3 months post consult
Adapted version of the Morisky Adherence Scale (MMAS-8)
Time frame: 1 month (post consult)
Adapted version of the Morisky Adherence Scale (MMAS-8)
Time frame: 3 months (post consult)
MyHeadHealth tracker
Time frame: 1 month (post consult)
MyHeadHealth tracker
Time frame: 3 months (post consult)
Self-Efficacy for Home Exercise Program Scale (SEHEPS)
Time frame: Baseline (consult)
Self-Efficacy for Home Exercise Program Scale (SEHEPS)
Time frame: 1 month (post consult)
Self-Efficacy for Home Exercise Program Scale (SEHEPS)
Time frame: 3 months (post consult)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No. We do not plan to make patient data available to other researchers to protect the identity of our patients
Related trials for Post Concussion Syndrome
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gihan Perera, MD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing MyHeadHealth online application in people with Post Concussion Syndrome, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Murphy, PhD (905-536-9612, murphj11@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral Symptoms Inventory (time frame: Baseline (at consult)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.