Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123058
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2005-07-20
Brief Title:
Comparison of Two Programs to Improve Blood Pressure Treatment Adherence
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Take Control of Your Blood Pressure TCYB
Status:
COMPLETED
Status Verified Date:
2014-09
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 purpose of this study is to improve adherence to blood pressure BP monitoring and medication compliance in individuals with high BP
Detailed Description:
BACKGROUND
High BP is a major health problem which contributes to high levels of morbidity and mortality Elevated BP levels are a major risk factor for stroke coronary artery disease CAD congestive heart failure CHF and kidney disease In the United States stroke rates are no longer improving and CHF and kidney failure rates continue to increase Despite the availability of effective treatment only 25 of individuals with high BP are able to control it effectively The reasons for poor BP control vary however a predominant reason is poor adherence to medication instructions and life-style modification recommendations This study will address these two sources of poor BP control through a real world multifaceted approach
DESIGN NARRATIVE
This study will compare a nurse-administered tailored program to a home BP monitoring program to evaluate the impact each program has on BP control The 5-year randomized controlled study will take place in a primary care setting and will enroll individuals with high BP The nurse-administered program will be based on the principles of the Health Decision Model and will be designed to increase awareness yet be easily integrated into the participants medical care so as to enhance adherence with the prescribed treatment The use of home BP monitors has been found to be associated with increased self management medication adherence and improved BP control
Five hundred seventy individuals with high BP from two primary care clinics will be randomly assigned to receive either the nurse-administered program home BP monitoring program both programs or regular medical care Based on an initial assessment participants assigned to the nurse-administered program will be involved in a behavioral education telephone program to promote medication adherence This program will include support reminders and information on the risks of high BP health behaviors patientdoctor communication literacy and side effects Participants will receive continuous education and will be monitored and supported to enhance medication adherence Participants assigned to the home BP monitors will record their BP every other day and mail the results to the study physicians The primary outcome will be whether or not the participants BP is greater than 14090 mm Hg for non-diabetic individuals or greater than 13085 mm Hg for diabetic individuals at 6-month intervals over 24 months 5 total measurements Descriptive statistics will be computed for all study variables stratified by treatment group Because each participant may have a different number of measurements the study physicians will model the responses and evaluate the programs using a mixed effects model for dichotomous outcomes Based upon preliminary data this study will improve participants management of high BP decrease health care utilization and subsequently improve BP control
Additionally a subset n250 of those enrolled and randomized to either the nurse administered program or usual care will be evaluated separately on the programss effect on both primary blood pressure control and secondary outcome measures changes in hypertension risk perceptionsatisfaction with care patient confidence following recommended regimen and self-reported adherence to recommended regimens Masking for this is open label
High BP is a major health problem which contributes to high levels of morbidity and mortality Elevated BP levels are a major risk factor for stroke coronary artery disease CAD congestive heart failure CHF and kidney disease In the United States stroke rates are no longer improving and CHF and kidney failure rates continue to increase Despite the availability of effective treatment only 25 of individuals with high BP are able to control it effectively The reasons for poor BP control vary however a predominant reason is poor adherence to medication instructions and life-style modification recommendations This study will address these two sources of poor BP control through a real world multifaceted approach
DESIGN NARRATIVE
This study will compare a nurse-administered tailored program to a home BP monitoring program to evaluate the impact each program has on BP control The 5-year randomized controlled study will take place in a primary care setting and will enroll individuals with high BP The nurse-administered program will be based on the principles of the Health Decision Model and will be designed to increase awareness yet be easily integrated into the participants medical care so as to enhance adherence with the prescribed treatment The use of home BP monitors has been found to be associated with increased self management medication adherence and improved BP control
Five hundred seventy individuals with high BP from two primary care clinics will be randomly assigned to receive either the nurse-administered program home BP monitoring program both programs or regular medical care Based on an initial assessment participants assigned to the nurse-administered program will be involved in a behavioral education telephone program to promote medication adherence This program will include support reminders and information on the risks of high BP health behaviors patientdoctor communication literacy and side effects Participants will receive continuous education and will be monitored and supported to enhance medication adherence Participants assigned to the home BP monitors will record their BP every other day and mail the results to the study physicians The primary outcome will be whether or not the participants BP is greater than 14090 mm Hg for non-diabetic individuals or greater than 13085 mm Hg for diabetic individuals at 6-month intervals over 24 months 5 total measurements Descriptive statistics will be computed for all study variables stratified by treatment group Because each participant may have a different number of measurements the study physicians will model the responses and evaluate the programs using a mixed effects model for dichotomous outcomes Based upon preliminary data this study will improve participants management of high BP decrease health care utilization and subsequently improve BP control
Additionally a subset n250 of those enrolled and randomized to either the nurse administered program or usual care will be evaluated separately on the programss effect on both primary blood pressure control and secondary outcome measures changes in hypertension risk perceptionsatisfaction with care patient confidence following recommended regimen and self-reported adherence to recommended regimens Masking for this is open label
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070713 | NIH | None | httpsreporternihgovquickSearchR01HL070713 |