Development of a Targeted Patient Portal Intervention to... | NCT04646681

Studies
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes

NCT04646681

Sponsor

Carolyn L Turvey

Status

Completed

Last Update Posted

Jun 10, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Depression

Interventions

ConnectCare

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2021Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Nov 20, 2020

First Submission Date that Met QC Criteria

Nov 23, 2020

First Posted Date

Nov 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2022

Last Update Posted Date

Jun 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental		Behavioral: ConnectCare
Group 2	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ConnectCare	Behavioral	increased monitoring between clinical mental health visits	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Health Questionnaire (PHQ-9)	measures the severity of depression symptoms	Once per month for 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carolyn Turvey, phD	University of Iowa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa Carver College of Medicine, Dept. of Psychiatry		Iowa City	Iowa	52242	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D000074822	Treatment Adherence and Compliance

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D015438	Health Behavior

Browse Leaves

Not provided

Browse Branches

Not provided