- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00243425
Patient-Centered Depression Care for African Americans
The investigators propose to answer the following research question: Does a multifaceted, culturally tailored intervention that focuses on the specific concerns and preferences of African American patients with depression and their primary care providers improve the processes and outcomes of care for African Americans to a greater degree than a standard state-of-the art depression intervention?
This study will determine whether two new educational programs can improve the care for depression in African Americans. These programs may include visits with a depression case manager and access to educational materials, such as a videotape, a calendar, pamphlets, and books. One program is a standard quality improvement program for depression that has been shown to be effective in most patients. The other program is similar, but has materials that focus more on the patient's specific culture, beliefs, values, and preferences.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bri K Ghods, B.S.
- Phone Number: 263 410-522-6500
- Email: bghods@jhmi.edu
Study Locations
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Recruiting
- Christiana Care Health Services
-
Contact:
- James M Gill, MD, MPH
- Phone Number: 302-477-3324
- Email: JGill@Christianacare.org
-
Sub-Investigator:
- James M Gill, MD, MPH
-
-
Maryland
-
Baltimore, Maryland, United States, 21215
- Recruiting
- Sinai Hospital
-
Contact:
- Robert T Chow, MD
- Phone Number: 410-601-6856
-
Sub-Investigator:
- Robert T Chow, MD
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins School of Medicine
-
Contact:
- Lisa A Cooper, MD, MPH
- Phone Number: 410-614-3659
- Email: lisa.cooper@jhmi.edu
-
Principal Investigator:
- Lisa A Cooper, MD, MPH
-
Baltimore, Maryland, United States, 21211
- Recruiting
- Johns Hopkins Community Phsyicians
-
Contact:
- Gary J Noronha, M.D.
- Phone Number: 410-338-3421
-
Sub-Investigator:
- Gary J Noronha, MD
-
Baltimore, Maryland, United States, 21221
- Recruiting
- Baltimore Medical Systems, Middlesex Health Center
-
Contact:
- Melissa Treola
- Phone Number: 410-558-4700
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who have experienced two weeks or more of depressed mood/ loss of interest in the past year
- Patients who have experienced one week or more of depressed mood or loss of interest in the past month
- Self defined race or ethnicity African American
- Able to give written consent
Exclusion Criteria:
- Current alcohol or drug abuse
- History of mania
- Grief reaction or bereavement within the past 2 months
- Pregnancy
- Life expectancy less than 1 year
- Non English speaking
- Current specialty mental health care (at least 2 visits in past 6 weeks and appt scheduled in future
- Plan to change health care or primary care Provider in next 12 months
- Active suicidal thoughts and plans
- Residing in US for less than 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Compare the effectiveness of a culturally tailored intervention with the effectiveness of a standard intervention by evaluating its impact on patient outcomes (remission of depression, depression symptom level, functional status) at 6 and 12 months.
|
Secondary Outcome Measures
Outcome Measure |
---|
Evaluating intervention impact on processes of care (satisfaction of care, guideline concordant care, patient involvement in participatory decision making, communication skills) rated by patients and providers at 6 and 12 months.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lisa A Cooper, MD, MPH, Johns Hopkins University
Publications and helpful links
General Publications
- Cooper LA, Roter DL, Johnson RL, Ford DE, Steinwachs DM, Powe NR. Patient-centered communication, ratings of care, and concordance of patient and physician race. Ann Intern Med. 2003 Dec 2;139(11):907-15. doi: 10.7326/0003-4819-139-11-200312020-00009.
- Cooper LA, Gonzales JJ, Gallo JJ, Rost KM, Meredith LS, Rubenstein LV, Wang NY, Ford DE. The acceptability of treatment for depression among African-American, Hispanic, and white primary care patients. Med Care. 2003 Apr;41(4):479-89. doi: 10.1097/01.MLR.0000053228.58042.E4.
- Cooper-Patrick L, Gallo JJ, Powe NR, Steinwachs DM, Eaton WW, Ford DE. Mental health service utilization by African Americans and Whites: the Baltimore Epidemiologic Catchment Area Follow-Up. Med Care. 1999 Oct;37(10):1034-45. doi: 10.1097/00005650-199910000-00007.
- Kaplan SH, Greenfield S, Ware JE Jr. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Med Care. 1989 Mar;27(3 Suppl):S110-27. doi: 10.1097/00005650-198903001-00010. Erratum In: Med Care 1989 Jul;27(7):679.
- Roter DL, Stewart M, Putnam SM, Lipkin M Jr, Stiles W, Inui TS. Communication patterns of primary care physicians. JAMA. 1997 Jan 22-29;277(4):350-6.
- Gallo JJ, Marino S, Ford D, Anthony JC. Filters on the pathway to mental health care, II. Sociodemographic factors. Psychol Med. 1995 Nov;25(6):1149-60. doi: 10.1017/s0033291700033122.
- Cooper-Patrick L, Crum RM, Ford DE. Characteristics of patients with major depression who received care in general medical and specialty mental health settings. Med Care. 1994 Jan;32(1):15-24. doi: 10.1097/00005650-199401000-00002.
- Cooper-Patrick L, Powe NR, Jenckes MW, Gonzales JJ, Levine DM, Ford DE. Identification of patient attitudes and preferences regarding treatment of depression. J Gen Intern Med. 1997 Jul;12(7):431-8. doi: 10.1046/j.1525-1497.1997.00075.x.
- Cooper LA, Ford DE, Ghods BK, Roter DL, Primm AB, Larson SM, Gill JM, Noronha GJ, Shaya EK, Wang NY. A cluster randomized trial of standard quality improvement versus patient-centered interventions to enhance depression care for African Americans in the primary care setting: study protocol NCT00243425. Implement Sci. 2010 Feb 23;5:18. doi: 10.1186/1748-5908-5-18.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
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
- R01HS013645 (U.S. AHRQ Grant/Contract)
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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