NCT00243425

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 24, 2005

Status Verified

October 1, 2005

First QC Date

October 21, 2005

Last Update Submit

October 21, 2005

Conditions

Keywords

Major Depressive Disorder;African Americans;Disparities;Quality Improvement;Patient Centered Care;Primary Care;Patient-Physician Relationship;

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Christiana Care Health Services

Wilmington, Delaware, 19803, United States

RECRUITING

Johns Hopkins Community Phsyicians

Baltimore, Maryland, 21211, United States

RECRUITING

Sinai Hospital

Baltimore, Maryland, 21215, United States

RECRUITING

Baltimore Medical Systems, Middlesex Health Center

Baltimore, Maryland, 21221, United States

RECRUITING

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (9)

  • 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.

    PMID: 2646486BACKGROUND
  • 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.

    PMID: 9002500BACKGROUND
  • 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.

    PMID: 8637945BACKGROUND
  • 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.

    PMID: 8277799BACKGROUND
  • 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.

    PMID: 10524370BACKGROUND
  • 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.

    PMID: 12665712BACKGROUND
  • 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.

    PMID: 14644893BACKGROUND
  • 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.

    PMID: 9229282BACKGROUND
  • 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.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Lisa A Cooper, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bri K Ghods, B.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

October 21, 2005

First Posted

October 24, 2005

Study Start

March 1, 2004

Study Completion

March 1, 2007

Last Updated

October 24, 2005

Record last verified: 2005-10

Locations