NCT00133068

Brief Summary

A large number of African-American and low socioeconomic patients have poorly controlled high blood pressure because of not being able to take their high blood pressure medications. This puts these patients at higher risk of heart and kidney disease, stroke and death. This study is designed to reduce the barriers that prevent patients from taking their high blood pressure medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
802

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Mar 2005

Typical duration for phase_4 hypertension

Geographic Reach
1 country

3 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

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

3.4 years

First QC Date

August 19, 2005

Last Update Submit

May 10, 2016

Conditions

Hypertension

Keywords

High Blood PressureHealth BehaviorsPatient Compliance

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    6 months

Secondary Outcomes (2)

  • Cost

    12 months

  • Blood pressure

    12 months

Study Arms (4)

1

OTHER

Control

Behavioral: Control

2

EXPERIMENTAL

Reduction of financial barrier

Behavioral: Reduction in financial barrier

3

EXPERIMENTAL

Computer Intervention

Behavioral: Computer

4

EXPERIMENTAL

Reduction of financial barrier and Computer Intervention

Behavioral: Computer intervention & reduction of financial barrier

Interventions

ComputerBEHAVIORAL

Computer intervention only

3
Reduction in financial barrierBEHAVIORAL

Copay only

2
Computer intervention & reduction of financial barrierBEHAVIORAL

computer intervention \& copay

4
ControlBEHAVIORAL

No intervention

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of the Philadelphia Veterans Administration Hospital Primary Care Clinic, PinnacleHealth Adult Outpatient Clinics and the VA Pittsburgh Healthcare System who have a diagnosis of hypertension; are currently taking antihypertensive medications; and have elevated blood pressure.

You may not qualify if:

  • Under 21 years of age
  • Have a diagnosis of:
  • Atrial fibrillation;
  • Metastatic cancer;
  • End stage renal disease (ESRD) with dialysis;
  • Dementia;
  • New York Heart Association (NYHA) class IV congestive heart failure (CHF);
  • Blind or deaf;
  • Other reason for life expectancy of less than 1 year.
  • Are currently participating in another experimental study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

PinnacleHealth Adult Outpatient Clinics

Harrisburg, Pennsylvania, 17101, United States

Location

Veterans Administration Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

  • Volpp KG, Troxel AB, Long JA, Ibrahim SA, Appleby D, Smith JO, Jaskowiak J, Helweg-Larsen M, Doshi JA, Kimmel SE. A randomized controlled trial of co-payment elimination: the CHORD trial. Am J Manag Care. 2015 Aug;21(8):e455-64.

    PMID: 26625505DERIVED

MeSH Terms

Conditions

HypertensionHealth BehaviorPatient Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehaviorPatient Acceptance of Health CareTreatment Adherence and Compliance

Study Officials

  • Stephen E. Kimmel, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stephen E. Kimmel, M.D., M.S.C.E,

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 22, 2005

Study Start

March 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(3)