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OpenTrials
Completed

NCT Number: NCT00133068

Collaboration to Reduce Disparities in Hypertension

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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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PinnacleHealth Adult Outpatient Clinics, Harrisburg, Pennsylvania, United States

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About this study

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:

  • 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.

  • 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.

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer

Behavioral

Computer intervention only

Reduction in financial barrier

Behavioral

Copay only

Computer intervention & reduction of financial barrier

Behavioral

computer intervention & copay

Control

Behavioral

No intervention

Primary outcomes

  1. Blood pressure

    Time frame: 6 months

Secondary outcomes

  1. Cost

    Time frame: 12 months

  2. Blood pressure

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Dickinson College
  • Pennsylvania Department of Health
  • Pfizer

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 22, 2005
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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