- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646681
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes (Patient Portal)
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence, Satisfaction, and Outcomes
Study Overview
Detailed Description
This study is being done in 3 phases. First 2 phases were observational with total enrollment of 300 subjects. The final 3rd phase is interventional and we are anticipating to enroll 50 subjects. It is described below.
Patients being treated for depressive symptoms at the University of Iowa, Department of Psychiatry are invited to participate. Participants will complete a remote (phone or video) visit. After being informed about the study and potential risks, those who consent to being in the study will be assigned to one of two groups. They will complete an online survey and receive some basic training on patient portals. After the visit. both groups will be followed for 6 months. Depending on their group assignment, they will complete:
- two to five phone calls with a study team member and
- two to five online questionnaires
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Carver College of Medicine, Dept. of Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English speaking,
- PHQ-9 score of 10 or higher (questions 1-8 only),
- Taking medication for depressive symptoms,
- 1 or more appointments scheduled or planned with University of Iowa psychiatry provider in next 6 months,
- Home computer w/internet access,
- MyChart (University of Iowa Healthcare's patient portal) account/MyChart enrollment
Exclusion Criteria:
- Psychotic disorder/symptoms,
- Current substance use disorders (other than alcohol, tobacco, marijuana),
- Active suicidal ideation within past 1 year,
- Cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group 2
|
|
Experimental: Group 1
|
increased monitoring between clinical mental health visits
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire (PHQ-9)
Time Frame: Once per month for 6 months
|
measures the severity of depression symptoms
|
Once per month for 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carolyn Turvey, phD, University of Iowa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201805861
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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