DepressionPatient PortalNCT04646681
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes
A study testing ConnectCare in people with Depression, run by Carolyn L Turvey at 1 site in United States.
Trial summary
The purpose of this research study is to learn how best to use patient portals to help improve the treatment of mood disorders. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Depression
- What is being tested?
- ConnectCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 30 Apr 2022
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychotic disorder/symptoms,
- Current substance use disorders (other than alcohol, tobacco, marijuana),
- Active suicidal ideation within past 1 year,
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Carver College of Medicine, Dept. of Psychiatry
Iowa City, Iowa, 52242
About this study
Official title: Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence, Satisfaction, and Outcomes
The purpose of this research study is to learn how best to use patient portals to help improve the treatment of mood disorders.
Read the 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
- Conditions
- Depression
- Being tested
- ConnectCare
- Keywords
- patient portals, treatment adherence
- Medical subject headings
- Depression, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConnectCareBehavioural
increased monitoring between clinical mental health visits
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Behavioral: ConnectCare |
| Group 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
measures the severity of depression symptoms
Measured: Once per month for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start31 Mar 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolyn L Turvey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carolyn L Turvey, University of Iowa
- Investigators
- Carolyn Turvey, phD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646681
- Sponsor's protocol ID
- 201805861
- Acronym
- Patient Portal
- Status last verified
- Jun 2022
- First submitted
- 20 Nov 2020
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence, Satisfaction, and Outcomes
- ClinicalTrials.gov ID
- NCT04646681
- Acronym / sponsor ID
- Patient Portal / 201805861
- Conditions
- Depression
- Keywords
- patient portals, treatment adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Carolyn L TurveyUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Nov 2020 (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.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: ConnectCare |
| Group 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- Psychotic disorder/symptoms,
- Current substance use disorders (other than alcohol, tobacco, marijuana),
- Active suicidal ideation within past 1 year,
- Cognitive impairment
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 |
|---|---|---|
| ConnectCareincreased monitoring between clinical mental health visits | Behavioural | Group 1 |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: Once per month for 6 months
measures the severity of depression symptoms
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 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Carolyn Turvey, phD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConnectCare in people with Depression, run by Carolyn L Turvey at 1 site in United States.
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 6 inclusion and 4 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 Jun 2022. 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 United States. 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?
Patient Health Questionnaire (PHQ-9) (time frame: Once per month for 6 months). 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 Jun 2022.