Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 12:17 AM
Study NCT ID:
NCT00133068
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2005-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collaboration to Reduce Disparities in Hypertension
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Collaboration to Reduce Disparities in Hypertension
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: