Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes (Patient Portal)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ConnectCare
Sponsored by
About this trial
This is an interventional health services research trial for Depression focused on measuring patient portals, treatment adherence
Eligibility Criteria
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
Sites / Locations
- University of Iowa Carver College of Medicine, Dept. of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
Patient Health Questionnaire (PHQ-9)
measures the severity of depression symptoms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04646681
Brief Title
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes
Acronym
Patient Portal
Official Title
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence, Satisfaction, and Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carolyn L Turvey
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
The purpose of this research study is to learn how best to use patient portals to help improve the treatment of mood disorders.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
patient portals, treatment adherence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
ConnectCare
Intervention Description
increased monitoring between clinical mental health visits
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
measures the severity of depression symptoms
Time Frame
Once per month for 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Turvey, phD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Carver College of Medicine, Dept. of Psychiatry
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes
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