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Collaboration to Reduce Disparities in Hypertension

Collaboration to Reduce Disparities in Hypertension

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00133068
Enrollment
802
Registered
2005-08-22
Start date
2005-03-31
Completion date
2008-08-31
Last updated
2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

High Blood Pressure, Health Behaviors, Patient Compliance

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.

Detailed description

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.

Interventions

BEHAVIORALComputer

Computer intervention only

BEHAVIORALReduction in financial barrier

Copay only

BEHAVIORALComputer intervention & reduction of financial barrier

computer intervention & copay

BEHAVIORALControl

No intervention

Sponsors

Pennsylvania Department of Health
CollaboratorOTHER_GOV
Dickinson College
CollaboratorOTHER
Pfizer
CollaboratorINDUSTRY
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Blood pressure6 months

Secondary

MeasureTime frame
Cost12 months
Blood pressure12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026