- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00571454
Culturally Sensitive Depression Care Management for Latino Primary Care Patients
October 28, 2009 updated by: Butler Hospital
The purpose of this study is to determine whether telephonic depression care management can improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and are receiving an antidepressant from their primary care doctor.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02908
- Neighborhood Health Plan of RI
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Latino
- Adult
- Received an antidepressant prescription from primary care provider
- Not current receiving care from behavioral health provider
- Diagnosis of major depression, minor depression, dysthymia, or significant depression symptoms
- English or Spanish speaking
- Member, Neighborhood Health Plan of RI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 2
Treatment as usual
|
|
Experimental: 1
Telephone depression care management + treatment as usual
|
1 call per week for first 4 weeks 1 call every other week for next 8 weeks |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quick Inventory of Depressive Symptomatology - Clinician Administered (QIDS-C)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Center for Epidemiological Studies-- Depression
Time Frame: 3 months
|
3 months
|
WHO Disability Assessment Schedule (WHO-DAS)
Time Frame: 3 months
|
3 months
|
Treatment Utilization
Time Frame: 3 months
|
3 months
|
Treatment Satisfaction
Time Frame: 3 months
|
3 months
|
costs: health care utilization
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa A Uebelacker, PhD, Butler Hospital
- Principal Investigator: Beth Ann Marootian, MPH, Neighborhood Health Plan of RI
- Principal Investigator: Ivan W Miller, PhD, Butler Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
December 10, 2007
First Submitted That Met QC Criteria
December 10, 2007
First Posted (Estimate)
December 12, 2007
Study Record Updates
Last Update Posted (Estimate)
October 30, 2009
Last Update Submitted That Met QC Criteria
October 28, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RWJ
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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