Bipolar DisorderNCT03575728
Delivering Telemetry-Triggered Educational Content Using MyChart in Mood Disorders
A study testing MyChart-MHT in people with Bipolar Disorder and Mood Disorders, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Bipolar Disorder, Mood Disorders
- What is being tested?
- MyChart-MHT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2019to 15 Dec 2019
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemetry-Triggered Educational Content Delivery Using MyChart in Mood Disorders
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.
Read the 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.
- Conditions
- Bipolar Disorder, Mood Disorders
- Being tested
- MyChart-MHT
- Keywords
- Mental Health, Information Technology, Chronic Disease Prevention and Management, Support Patient Self-Care
- Medical subject headings
- Bipolar Disorder, Mood Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyChart-MHTOther
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
| Study group | Role | What they receive |
|---|---|---|
| Mood disorder | Other | Participants who screen positive for a history of mood disorders Receives: Other: MyChart-MHT |
| Other | Other | Participants who do not screen positive for a history of mood disorders Receives: Other: MyChart-MHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization rate
Trend in utilization rate over time in users in 'mood disorder' arm
Measured: Six month period of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start15 May 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Based on self-report answers to screening questions, participants will be divided into two groups: (i) those who screen positive for a history of mood disorders and (ii) all other participants. All outcome measures apply only to the mood disorder group.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Kreindler, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575728
- Sponsor's protocol ID
- 0382017
- Status last verified
- Dec 2024
- First submitted
- 21 Jun 2018
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemetry-Triggered Educational Content Delivery Using MyChart in Mood Disorders
- ClinicalTrials.gov ID
- NCT03575728
- Acronym / sponsor ID
- 0382017
- Conditions
- Bipolar Disorder, Mood Disorders
- Keywords
- Mental Health, Information Technology, Chronic Disease Prevention and Management, Support Patient Self-Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 2 Jul 2018 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Based on self-report answers to screening questions, participants will be divided into two groups: (i) those who screen positive for a history of mood disorders and (ii) all other participants. All outcome measures apply only to the mood disorder group.
| Arm | Type | Receives |
|---|---|---|
| Mood disorder | Other | Other: MyChart-MHTParticipants who screen positive for a history of mood disorders |
| Other | Other | Other: MyChart-MHTParticipants who do not screen positive for a history of mood disorders |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MyChart-MHTAll 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 | Mood disorder, Other |
Primary outcome
Utilization rate
Time frame: Six month period of study
Trend in utilization rate over time in users in 'mood disorder' arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyChart-MHT in people with Bipolar Disorder and Mood Disorders, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization rate (time frame: Six month period of study). 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 10 Dec 2024.