NCT00233220

Brief Summary

The purpose of this study is to test the effectiveness of a multi-component evidence-based intervention that targets both patients and physicians, in improving BP control rates in patients followed in 30 Community/Migrant Health Centers (C/MHCs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,039

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

5.5 years

First QC Date

October 3, 2005

Last Update Submit

February 12, 2014

Conditions

Cardiovascular DiseasesHypertension

Outcome Measures

Primary Outcomes (1)

  • Control BP

    Measured at Year 1

Secondary Outcomes (3)

  • Change in systolic BP and diastolic BP

    Measured at Year 1

  • Maintenance of the intervention effects

    Measured at Year 1

  • Cost effectiveness of the intervention

    Measured at Year 1

Study Arms (2)

1

EXPERIMENTAL

Patients and doctors will take part in a multicomponent, multi-level intervention.

Behavioral: Multicomponent, multi-level intervention targeted at physicians and patients

2

ACTIVE COMPARATOR

Patients will receive usual care.

Behavioral: Usual Care

Interventions

Multicomponent, multi-level intervention targeted at physicians and patientsBEHAVIORAL

The patient intervention will include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN; behavioral counseling by trained C/MHC dieticians on lifestyle modification; and home BP monitoring to activate patients in their own care. The physician intervention comprises online continuing medical education (CME) courses on management of HTN based on the Joint National Committee-7 (JNC-7) guidelines; online HTN rounds or case conferences with HTN specialists; and feedback to physicians on clinical performance measures via computerized decision support systems. The intervention will be delivered to patients every 3 months during regular office visits for 12 months, while the physician intervention will occur every month for the duration of the trial.

1
Usual CareBEHAVIORAL

Patients will receive usual care.

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Uncontrolled Hypertension
  • African American

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

Related Publications (4)

  • Ogedegbe G, Tobin JN, Fernandez S, Gerin W, Diaz-Gloster M, Cassells A, Khalida C, Pickering T, Schoenthaler A, Ravenell J. Counseling African Americans to Control Hypertension (CAATCH) trial: a multi-level intervention to improve blood pressure control in hypertensive blacks. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):249-56. doi: 10.1161/CIRCOUTCOMES.109.849976.

    PMID: 20031845BACKGROUND

  • Fernandez S, Tobin JN, Cassells A, Diaz-Gloster M, Kalida C, Ogedegbe G. The counseling African Americans to Control Hypertension (CAATCH) Trial: baseline demographic, clinical, psychosocial, and behavioral characteristics. Implement Sci. 2011 Sep 1;6:100. doi: 10.1186/1748-5908-6-100.

    PMID: 21884616BACKGROUND

  • Forsyth J, Schoenthaler A, Chaplin WF, Ogedegbe G, Ravenell J. Perceived discrimination and medication adherence in black hypertensive patients: the role of stress and depression. Psychosom Med. 2014 Apr;76(3):229-36. doi: 10.1097/PSY.0000000000000043.

    PMID: 24677163DERIVED

  • Ogedegbe G, Tobin JN, Fernandez S, Cassells A, Diaz-Gloster M, Khalida C, Pickering T, Schwartz JE. Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects. Circulation. 2014 May 20;129(20):2044-51. doi: 10.1161/CIRCULATIONAHA.113.006650. Epub 2014 Mar 21.

    PMID: 24657991DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Gbenga G Ogedegbe, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

September 1, 2004

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

US(1)