Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248872
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2005-11-03
Brief Title:
A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients
Status:
COMPLETED
Status Verified Date:
2017-02
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:
The long-term objective is to determine whether better adherence to prescribed medications can be achieved through positive affect induction and self-affirmation leading to reduction in hypertension-related outcomes such as end-stage renal disease stroke and cardiovascular mortality among African American patients with poorly controlled hypertension
Detailed Description:
The objective of this randomized trial is to evaluate among African American patients with poorly controlled hypertension whether a novel intervention of positive affect induction and self-affirmation is more effective than usual care in increasing adherence to prescribed antihypertensive medications The main outcome will be the change in medication adherence rate from enrollment to 12 months which is defined as percentage of prescribed doses taken by the patient during the interval of observation as measured by electronic medication event monitoring system MEMS
2 Secondary objectives
1 To determine among African American patients with poorly controlled hypertension the extent to which positive affect induction and self-affirmation influence patients self-efficacy
2 To determine among African American patients with poorly controlled hypertension the extent to which positive affect induction and self-affirmation influence medication adherence in those with significant depressive symptomatology CES-D score 16
3 To determine among African-American patients with poorly controlled hypertension the extent to which positive affect induction and self-affirmation influence blood pressure control
4 To explore the health beliefs of hypertensive African-American patients regarding the meaning causes and treatment of hypertension In addition the factors that facilitate and prevent adherence to prescribed antihypertensive medications will also be explored using a qualitative approach
2 Secondary objectives
1 To determine among African American patients with poorly controlled hypertension the extent to which positive affect induction and self-affirmation influence patients self-efficacy
2 To determine among African American patients with poorly controlled hypertension the extent to which positive affect induction and self-affirmation influence medication adherence in those with significant depressive symptomatology CES-D score 16
3 To determine among African-American patients with poorly controlled hypertension the extent to which positive affect induction and self-affirmation influence blood pressure control
4 To explore the health beliefs of hypertensive African-American patients regarding the meaning causes and treatment of hypertension In addition the factors that facilitate and prevent adherence to prescribed antihypertensive medications will also be explored using a qualitative approach
Study Oversight
Has Oversight DMC:
None
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?:
None