NCT01910857

Brief Summary

  • The overall hypothesis for the project is that racial health disparities will be reduced by improving hypertension control in African Americans.
  • This will be accomplished through the development, implementation, and evaluation of a cost-effective hypertension control strategy based on the involvement of a community health worker.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jan 2012

Typical duration 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

Study Start

First participant enrolled

January 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

1.9 years

First QC Date

July 23, 2013

Last Update Submit

August 24, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure (mmHg)

    6 months

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Lifestyle counseling. 6 group meetings,facilitated by community health worker, focusing on lifestyle change, eg, weight loss, physical activity, low salt, stress reduction

Behavioral: Lifestyle counseling

Control

NO INTERVENTION

Standard care

Interventions

Lifestyle counselingBEHAVIORAL

weight reduction, low salt, physical activity, stress reduction

Lifestyle counseling

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African Americans with uncontrolled hypertension, followed at Progressive Community Health Centers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lisbon Avenue Health Center

Milwaukee, Wisconsin, 3522, United States

Location

Hillside Family Health Center

Milwaukee, Wisconsin, 53205, United States

Location

Related Publications (1)

  • Tully M, Kos A, Eastwood D, Kusch J, Kotchen T. Implementation of an Adjunct Strategy to Reduce Blood Pressure in Blacks with Uncontrolled Hypertension: a Pilot Project. Ethn Dis. 2015 Spring;25(2):168-74.

    PMID: 26118144DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus, Assoc Dean for Clinical Research

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 30, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

US(2)