Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006552
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-11-28
Brief Title:
Adherence to Antihypertensive Therapy--Data Analyses
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-05
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:
To assess factors that may influence adherence to antihypertensive drug therapy
Detailed Description:
BACKGROUND
High blood pressure continues to be a highly prevalent condition affecting about 20 percent of the US population Untreated it may lead to coronary heart disease stroke kidney failure and other complications Medication is a major means of controlling hypertension and averting these debilitating consequences Treatment with drugs however is undermined by suboptimal adherence to therapy Forgetting to take medications is the most commonly elicited reason for lapses in medication use but side effects health beliefs lack of knowledge of disease and treatment instructions and financial barriers may also interfere Determining those factors that 1 are predictably associated with fluctuations in adherence such as day of the week holidays medication appointments 2 ameliorate the impact of nonadherence such as pharmacologic properties of drugs that protect patients during adherence lapses and 3 correlate with the accuracy of adherence reporting by patients will assist in anticipating and addressing adherence obstacles and serve as the objectives of the study
DESIGN NARRATIVE
The study used data collected from electronic adherence monitors questionnaires and computerized medical records that contained blood pressure readings during a prior investigation of antihypertensive adherence This earlier investigation conducted from 1994 to 1997 involved 286 members of Harvard Pilgrim Health Care who were on single drug therapy for mild to moderate hypertension Objective 1 evaluated the impact of temporal factors such as weekend versus weekday holidays seasons and impending medical appointments on adherence by analyzing their effects on the daily rate of dosing recorded by electronic medication monitors Time trend models were used for this purpose Objective 2 assessed the impact of pharmacologic duration of action on the level of antihypertensive adherence required to maintain a goal blood pressure of 14090 mmHg This involved determining if the relationship between adherence and blood pressure was modified by the duration of drug effect Objective 3 concerning correlates of accuracy of reported adherence was approached by verifying reported adherence against electronically measured adherence Predictors and correlates of accurately reported adherence such as patient age gender raceethnicity education socioeconomic status health beliefs and measures of health status were then identified by cross tabulating and statistical modeling accurate reporting against these factors
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
High blood pressure continues to be a highly prevalent condition affecting about 20 percent of the US population Untreated it may lead to coronary heart disease stroke kidney failure and other complications Medication is a major means of controlling hypertension and averting these debilitating consequences Treatment with drugs however is undermined by suboptimal adherence to therapy Forgetting to take medications is the most commonly elicited reason for lapses in medication use but side effects health beliefs lack of knowledge of disease and treatment instructions and financial barriers may also interfere Determining those factors that 1 are predictably associated with fluctuations in adherence such as day of the week holidays medication appointments 2 ameliorate the impact of nonadherence such as pharmacologic properties of drugs that protect patients during adherence lapses and 3 correlate with the accuracy of adherence reporting by patients will assist in anticipating and addressing adherence obstacles and serve as the objectives of the study
DESIGN NARRATIVE
The study used data collected from electronic adherence monitors questionnaires and computerized medical records that contained blood pressure readings during a prior investigation of antihypertensive adherence This earlier investigation conducted from 1994 to 1997 involved 286 members of Harvard Pilgrim Health Care who were on single drug therapy for mild to moderate hypertension Objective 1 evaluated the impact of temporal factors such as weekend versus weekday holidays seasons and impending medical appointments on adherence by analyzing their effects on the daily rate of dosing recorded by electronic medication monitors Time trend models were used for this purpose Objective 2 assessed the impact of pharmacologic duration of action on the level of antihypertensive adherence required to maintain a goal blood pressure of 14090 mmHg This involved determining if the relationship between adherence and blood pressure was modified by the duration of drug effect Objective 3 concerning correlates of accuracy of reported adherence was approached by verifying reported adherence against electronically measured adherence Predictors and correlates of accurately reported adherence such as patient age gender raceethnicity education socioeconomic status health beliefs and measures of health status were then identified by cross tabulating and statistical modeling accurate reporting against these factors
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03HL064273 | NIH | None | httpsreporternihgovquickSearchR03HL064273 |