- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575728
Telemetry-Triggered Educational Content Delivery Using MyChart in Mood Disorders
December 18, 2019 updated by: Dr. David Kreindler, Sunnybrook Health Sciences Centre
Mood disorders - principally major depressive disorder and bipolar disorder - are a significant public health issue affecting one in four people during their lives in total, over 8 million Canadians are affected by mood disorders, costing the economy over $6 billion annually.
At Sunnybrook, 75% of inpatient mental health admissions are due to mood disorders.
Mood disorders are generally recurrent: approximately half of depression is recurrent; chronic bipolar disorder is typical.
Use of ratings scales by patients and clinicians to track symptoms has also been shown to enhance outcomes such as remission, medication adherence, and patient engagement.
Education is considered a key component of treating mood disorders.
However, which educational information is useful can vary: in depression, changes in illness severity have been shown to affect what information is absorbed, and timing is also important.To address this, this project will deliver, for the first time ever, a system for using data from patients with mood disorders' electronic mood journals, integrated into Sunnybrook's "MyChart" personal health record system, to drive just-in-time delivery of educational interventions, using feedback from users to maximize its usefulness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project will integrate mood-journaling software ("MHT") developed here at Sunnybrook (SHSC) into SHSC's "MyChart" patient portal system.
Next, using alternating expert input and input from focus groups of patients, we will develop a library of educational content and rules to select and drive delivery of content that will, for the first time, allow patients with mood disorders to receive customized, just-in-time educational content using their own self-report data to drive selection and timing of the delivery of the content.
While we expect that this innovation should be beneficial to its users, we cannot assess this without adequate numbers of users.
So, in this project, we will make this system available to MyChart users for six months and collect ongoing feedback on user satisfaction, continuously refining the system over the six months with the goal of steadily increasing the number of users frequently using this system.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
i) Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Mood disorder
Participants who screen positive for a history of mood disorders
|
All participants in this study will receive targeted psycho-educational interventions from time to time based on symptom severity reports as determined by the software algorithm
|
Other: Other
Participants who do not screen positive for a history of mood disorders
|
All participants in this study will receive targeted psycho-educational interventions from time to time based on symptom severity reports as determined by the software algorithm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utilization rate
Time Frame: Six month period of study
|
Trend in utilization rate over time in users in 'mood disorder' arm
|
Six month period of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2019
Primary Completion (Actual)
December 15, 2019
Study Completion (Actual)
December 15, 2019
Study Registration Dates
First Submitted
June 21, 2018
First Submitted That Met QC Criteria
June 21, 2018
First Posted (Actual)
July 2, 2018
Study Record Updates
Last Update Posted (Actual)
December 20, 2019
Last Update Submitted That Met QC Criteria
December 18, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0382017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mood Disorders
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Université du Québec a MontréalCiusss de L'Est de l'Île de Montréal; PhysioExtra; EnergirRecruitingDepression ; Anxiety With Depressed Mood ; Mood Disorder, Adjustment Disorder With Depressed MoodCanada
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Joliet Center for Clinical ResearchAbbottCompleted
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National Institute of Mental Health (NIMH)Completed
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National Institute of Mental Health (NIMH)Completed
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
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University of Colorado, DenverCompletedMood Disorders | Irritable MoodUnited States
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VA Office of Research and DevelopmentCompleted
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