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Collaboration to Reduce Disparities in Hypertension

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00133068
Collaborator
Pennsylvania Department of Health (Other), Dickinson College (Other), Pfizer (Industry)
802
Enrollment
3
Locations
4
Arms
41
Duration (Months)
267.3
Patients Per Site
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Computer
  • Behavioral: Reduction in financial barrier
  • Behavioral: Computer intervention & reduction of financial barrier
  • Behavioral: Control
 Phase 4

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.

  1. 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.

  1. 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.

  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
802 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Collaboration to Reduce Disparities in Hypertension
Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Control

Behavioral: Control
No intervention
Experimental: 2

Reduction of financial barrier

Behavioral: Reduction in financial barrier
Copay only
Experimental: 3

Computer Intervention

Behavioral: Computer
Computer intervention only
Experimental: 4

Reduction of financial barrier and Computer Intervention

Behavioral: Computer intervention & reduction of financial barrier
computer intervention & copay

Outcome Measures

Primary Outcome Measures

  1. Blood pressure [6 months]

Secondary Outcome Measures

  1. Cost [12 months]

  2. Blood pressure [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PinnacleHealth Adult Outpatient Clinics Harrisburg Pennsylvania United States 17101
2 Veterans Administration Medical Center Philadelphia Pennsylvania United States 19104
3 VA Pittsburgh Healthcare System Pittsburgh Pennsylvania United States 15240

Sponsors and Collaborators

  • University of Pennsylvania
  • Pennsylvania Department of Health
  • Dickinson College
  • Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephen E. Kimmel, Stephen E. Kimmel, M.D., M.S.C.E,, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00133068
Other Study ID Numbers:
  • 707850
First Posted:
Aug 22, 2005
Last Update Posted:
May 12, 2016
Last Verified:
May 1, 2016
Keywords provided by Stephen E. Kimmel, Stephen E. Kimmel, M.D., M.S.C.E,, University of Pennsylvania
High Blood Pressure
Health Behaviors
Patient Compliance
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of May 12, 2016