Adherence to Antihypertensive Therapy--Data Analyses

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00006552
First received: November 28, 2000
Last updated: June 23, 2005
Last verified: May 2005
  Purpose

To assess factors that may influence adherence to antihypertensive drug therapy.


Condition
Cardiovascular Diseases
Hypertension

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1999
Estimated Study Completion Date: August 2002
Detailed Description:

BACKGROUND:

High blood pressure continues to be a highly prevalent condition affecting about 20 percent of the U.S. 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 <140/90 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, race/ethnicity, education, socioeconomic status, health beliefs, and measures of health status were then identified by cross tabulating and statistical modeling accurate reporting against these factors.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00006552

Sponsors and Collaborators
Investigators
Investigator: Peter Choo Brigham and Women's Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006552     History of Changes
Other Study ID Numbers: 953
Study First Received: November 28, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014