NCT00379652

Brief Summary

Hypertension and diabetes are among the most common chronic diseases in the United States. Racial and ethnic minority groups are more at risk for these diseases than the Caucasian population. This study will attempt to identify factors that contribute to racial and ethnic differences in hypertension and diabetes care among minority patients of community health centers (CHCs). This information will be used to design and implement programs to improve quality of care in these communities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,204

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2006

Completed
3 years until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

September 20, 2006

Last Update Submit

January 9, 2023

Conditions

HypertensionDiabetes Mellitis

Keywords

Community Health CentersDiabetesBlood Pressure, High

Outcome Measures

Primary Outcomes (1)

  • Potential outcomes for the future intervention include systolic blood pressure, diastolic blood pressure, and hemoglobin A1c

    Measured from June to August 2008

Study Arms (4)

A

ACTIVE COMPARATOR

Patient-based intervention

Behavioral: Patient Education and Support

B

ACTIVE COMPARATOR

Health center-based intervention

Behavioral: Medical Practice Improvement

C

ACTIVE COMPARATOR

Combination of patient and health center-based intervention

Other: Combination Intervention to Include Medical Practice Improvement and Patient Education and Support

D

NO INTERVENTION

Control group: Neither patient-based nor center-based intervention

Interventions

Medical Practice ImprovementBEHAVIORAL

The details for the medical practice improvement intervention will be decided at a later date.

B
Patient Education and SupportBEHAVIORAL

The details for the patient education and support intervention will be decided at a later date.

A
Combination Intervention to Include Medical Practice Improvement and Patient Education and SupportOTHER

The details for this combination intervention will be decided at a later date.

C

Eligibility Criteria

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

You may qualify if:

  • Diabetes
  • Hypertension, as diagnosed by the average of two or more blood pressure measurements taken during two or more study visits following an initial screening
  • Race is 'Black' or ethnicity is 'Hispanic'
  • Patient at participating Community Health Center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Center for Community Health Education, Research, and Service

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

  • Ndumele CD, Ableman G, Russell BE, Gurrola E, Hicks LS. Publication of recruitment methods in focus group research of minority populations with chronic disease: a systematic review. J Health Care Poor Underserved. 2011 Feb;22(1):5-23. doi: 10.1353/hpu.2011.0031.

    PMID: 21317503DERIVED

  • Russell BE, Gurrola E, Ndumele CD, Landon BE, O'Malley JA, Keegan T, Ayanian JZ, Hicks LS; Community Health and Academic Medicine Partnership Project. Perspectives of non-Hispanic Black and Latino patients in Boston's urban community health centers on their experiences with diabetes and hypertension. J Gen Intern Med. 2010 Jun;25(6):504-9. doi: 10.1007/s11606-010-1278-0. Epub 2010 Feb 24.

    PMID: 20180156DERIVED

  • Ndumele CD, Russell BE, Ayanian JZ, Landon BE, Keegan T, O'Malley AJ, Hicks LS. Strategies to improve chronic disease management in seven metro Boston community health centers. Prog Community Health Partnersh. 2009 Fall;3(3):203-11. doi: 10.1353/cpr.0.0080.

    PMID: 19802379DERIVED

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Interventions

Patient Education as TopicPalliative Care

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPatient CareTherapeutics

Study Officials

  • LeRoi S. Hicks, MD, MPH

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

  • Thomas Keegan, PhD

    Harvard Medical School (HMS and HSDM)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 22, 2006

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

US(2)