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.

Condition	Intervention	Phase
Hypertension	Behavior: computer program & reduction of financial barriers	Phase IV

Further Study Details: 

Primary Outcomes: Blood pressure
Secondary Outcomes: Cost
Expected Total Enrollment:  928

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) reimburing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavorial 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 behavorial 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.

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients of the Philadelphia Veterans Administration Hospital Primary Care Clinic and PinnacleHealth Adult Outpatient Clinics 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, ESRD with dialysis, Dementia, NYHA class IV CHF, Blind or Deaf, Other reason for life expectancy of less than 1 year
• are currently participating in another experimental study

Please refer to this study by ClinicalTrials.gov identifier  NCT00133068

Jane A. Jaskowiak, B.S.N., R.N.      215-898-2625    jjaskowi@cceb.med.upenn.edu

Pennsylvania
      Veterans Administration Medical Center, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      PinnacleHealth Adult Outpatient Clinics, Harrisburg,  Pennsylvania,  17101,  United States; Recruiting

Study chairs or principal investigators

Stephen E. Kimmel, MD, MSCE,  Principal Investigator,  University of Pennsylvania   

Study ID Numbers:  707850
Last Updated:  August 19, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00133068
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23