Collaboration to Reduce Disparities in Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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The objective of this study is to determine the effectiveness and cost-effectiveness of two interventions aimed at reducing barriers to blood pressure (BP) control in an indigent and African-American population. Specifically, we will conduct a randomized controlled trial comparing BP control using either: (1) reimbursing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavioral arms (combined arms); or (4) neither.

The ultimate goal of this study is to reduce the incidence of HTN-related CVD among these populations thereby reducing cardiovascular health disparities. Specific aims of the study are to:

1. test whether receiving money each time the patient fills a prescription for medications improves BP control by a clinically significant amount.

H1: Reimbursing patients for filling prescriptions will significantly improve BP control.
2. test whether a computer-based behavioral intervention improves BP control by a clinically significant amount.

H2: A computer-based behavioral intervention will significantly improve BP control.
3. test whether the two interventions are more effective in improving BP control than either alone.

H3: The effect of improving BP control of administering both interventions together will be greater than the sum of the individual effects of each intervention alone.
4. examine the relative cost effectiveness of reimbursement for filling prescriptions, a computer-based behavioral intervention, and the combination of the two.

H4: Both interventions will be cost-effective relative to other commonly-covered services.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Control

Group Type OTHER

Control

Intervention Type BEHAVIORAL

No intervention

2

Reduction of financial barrier

Group Type EXPERIMENTAL

Reduction in financial barrier

Intervention Type BEHAVIORAL

Copay only

3

Computer Intervention

Group Type EXPERIMENTAL

Computer

Intervention Type BEHAVIORAL

Computer intervention only

4

Reduction of financial barrier and Computer Intervention

Group Type EXPERIMENTAL

Computer intervention & reduction of financial barrier

Intervention Type BEHAVIORAL

computer intervention \& copay

Interventions

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Computer

Computer intervention only

Intervention Type BEHAVIORAL

Reduction in financial barrier

Copay only

Intervention Type BEHAVIORAL

Computer intervention & reduction of financial barrier

computer intervention \& copay

Intervention Type BEHAVIORAL

Control

No intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No