Cardiovascular DiseasesNCT00006552
Adherence to Antihypertensive Therapy--Data Analyses
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess factors that may influence adherence to antihypertensive drug therapy. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1999to Aug 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To assess factors that may influence adherence to antihypertensive drug therapy.
Read the 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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2000 (estimated)
- Study startSep 1999
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Peter Choo, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006552
- Sponsor's protocol ID
- 953
- Other IDs
- R03HL064273
- Status last verified
- May 2005
- First submitted
- 28 Nov 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Choo PW, Rand CS, Inui TS, Lee ML, Canning C, Platt R. A cohort study of possible risk factors for over-reporting of antihypertensive adherence. BMC Cardiovasc Disord. 2001;1:6. doi: 10.1186/1471-2261-1-6. Epub 2001 Dec 13.
PubMed 11801191Choo PW, Rand CS, Inui TS, Lee ML, Ma CC, Platt R. A pharmacodynamic assessment of the impact of antihypertensive non-adherence on blood pressure control. Pharmacoepidemiol Drug Saf. 2000 Dec;9(7):557-63. doi: 10.1002/pds.539.
PubMed 11338913
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Antihypertensive Therapy--Data Analyses
- ClinicalTrials.gov ID
- NCT00006552
- Acronym / sponsor ID
- 953
- Conditions
- Cardiovascular Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Aug 2002 (actual)
- First posted
- 28 Nov 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
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 design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 11801191Choo PW, Rand CS, Inui TS, Lee ML, Canning C, Platt R. A cohort study of possible risk factors for over-reporting of antihypertensive adherence. BMC Cardiovasc Disord. 2001;1:6. doi: 10.1186/1471-2261-1-6. Epub 2001 Dec 13.
- Background: PubMed 11338913Choo PW, Rand CS, Inui TS, Lee ML, Ma CC, Platt R. A pharmacodynamic assessment of the impact of antihypertensive non-adherence on blood pressure control. Pharmacoepidemiol Drug Saf. 2000 Dec;9(7):557-63. doi: 10.1002/pds.539.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Choo
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006552, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.