COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication

September 10, 2013 updated by: AstraZeneca
The aim of this multi-centre survey is to assess treatment adherence and quality of life in a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

multi-centre survey of patients

Description

Inclusion Criteria:

  • Patients older than 21 years of age
  • Patients newly diagnosis with essential hypertension or with hypertension that is uncontrolled after being under the same antihypertensive treatment for at least 6 months (based on the criteria established by the Joint National Committee VII)
  • Patients capable of providing an informed consent

Exclusion Criteria:

  • Patients with secondary hypertension
  • Pregnant women or nursing mothers
  • Patients with acute illnesses or psychiatric diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance rate
Time Frame: 6 months
Identify the percentage of subjects compliant to their antihypertensive treatment.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life (MINICHAL Score)
Time Frame: 6 months
To compare and identify changes in the quality of life before and after anti-hypertensive treatment.
6 months
Type of pharmacological treatments
Time Frame: 6 months
To identify the pharmacological treatments used by physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension.
6 months
Factors affecting adherence to treatment
Time Frame: 6 months
To identify associated factors that may alter adherence to anti-hypertensive treatment.
6 months
Compliance rate by antihypertensive regimen used
Time Frame: 6 months
To compare treatment rate for different antihypertensive regimen used
6 months
Percentage of controlled patients
Time Frame: 6 months
To identify the percentage of patients reaching their target blood pressure according to the JNCVII criteria.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CME-ATA-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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