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

Primary Purpose

Post Concussion Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MyHeadHealth online application
Standard of Care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Concussion Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard of Care

    mHealth

    Arm Description

    Patients in the control group will receive standard of care for the treatment of post-concussion symptoms at our Integrated Adult Concussion Clinic

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

    Outcomes

    Primary Outcome Measures

    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
    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
    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

    Secondary Outcome Measures

    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
    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
    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
    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
    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
    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
    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.
    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.
    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
    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
    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).
    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).
    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).

    Full Information

    First Posted
    April 25, 2023
    Last Updated
    May 8, 2023
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05848193
    Brief Title
    mHealth Technology in the Treatment of Post-concussion Symptoms
    Acronym
    PERSIST
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2024 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    April 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Concussion Syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    Patients in the control group will receive standard of care for the treatment of post-concussion symptoms at our Integrated Adult Concussion Clinic
    Arm Title
    mHealth
    Arm Type
    Experimental
    Arm Description
    Patients in the intervention group will use MyHeadHealth - an online application to help in the completion of their treatment plan
    Intervention Type
    Other
    Intervention Name(s)
    MyHeadHealth online application
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Patients will receive Standard of Care from our concussion clinic as necessary as per the consultation with the physician
    Primary Outcome Measure Information:
    Title
    Neurobehavioral Symptoms Inventory
    Description
    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
    Time Frame
    Baseline (at consult)
    Title
    Neurobehavioral Symptoms Inventory
    Description
    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
    Time Frame
    1 Month post consult
    Title
    Neurobehavioral Symptoms Inventory
    Description
    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
    Time Frame
    3 Months post consult
    Secondary Outcome Measure Information:
    Title
    Assessment of Quality-of-Life (AQoL) Scale
    Description
    Measures patient quality of life (physical, emotional and mental) - total score out of 100 - Higher scores represent worsening psychosocial well-being and physical pain
    Time Frame
    Baseline (at consult)
    Title
    Assessment of Quality-of-Life (AQoL) Scale
    Description
    Measures patient quality of life (physical, emotional and mental) - total score out of 100 - Higher scores represent worsening psychosocial well-being and physical pain
    Time Frame
    1 month post consult
    Title
    Assessment of Quality-of-Life (AQoL) Scale
    Description
    Measures patient quality of life (physical, emotional and mental) - total score out of 100 - Higher scores represent worsening psychosocial well-being and physical pain
    Time Frame
    3 months post consult
    Title
    Short Assessment of Patient Satisfaction Measure
    Description
    Measures Patient Satisfaction with Care - score is totaled with higher scores (maximum of 28) indicating higher levels of satisfaction
    Time Frame
    Baseline (consult)
    Title
    Short Assessment of Patient Satisfaction Measure
    Description
    Measures Patient Satisfaction with Care - score is totaled with higher scores (maximum of 28) indicating higher levels of satisfaction
    Time Frame
    1 month post consult
    Title
    Short Assessment of Patient Satisfaction Measure
    Description
    Measures Patient Satisfaction with Care -score is totaled with higher scores (maximum of 28) indicating higher levels of satisfaction
    Time Frame
    3 months post consult
    Title
    Adapted version of the Morisky Adherence Scale (MMAS-8)
    Description
    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.
    Time Frame
    1 month (post consult)
    Title
    Adapted version of the Morisky Adherence Scale (MMAS-8)
    Description
    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.
    Time Frame
    3 months (post consult)
    Title
    MyHeadHealth tracker
    Description
    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
    Time Frame
    1 month (post consult)
    Title
    MyHeadHealth tracker
    Description
    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
    Time Frame
    3 months (post consult)
    Title
    Self-Efficacy for Home Exercise Program Scale (SEHEPS)
    Description
    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).
    Time Frame
    Baseline (consult)
    Title
    Self-Efficacy for Home Exercise Program Scale (SEHEPS)
    Description
    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).
    Time Frame
    1 month (post consult)
    Title
    Self-Efficacy for Home Exercise Program Scale (SEHEPS)
    Description
    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).
    Time Frame
    3 months (post consult)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jessica Murphy, PhD
    Phone
    905-536-9612
    Email
    murphj11@mcmaster.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gihan Perera, MD
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We do not plan to make patient data available to other researchers to protect the identity of our patients

    Learn more about this trial

    mHealth Technology in the Treatment of Post-concussion Symptoms

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