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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01274494
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : September 11, 2013
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease
High Blood Pressure

Study Type : Observational
Actual Enrollment : 1501 participants
Time Perspective: Prospective
Official Title: COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication
Study Start Date : May 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Compliance rate [ Time Frame: 6 months ]
    Identify the percentage of subjects compliant to their antihypertensive treatment.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Factors affecting adherence to treatment [ Time Frame: 6 months ]
    To identify associated factors that may alter adherence to anti-hypertensive treatment.

  4. Compliance rate by antihypertensive regimen used [ Time Frame: 6 months ]
    To compare treatment rate for different antihypertensive regimen used

  5. Percentage of controlled patients [ Time Frame: 6 months ]
    To identify the percentage of patients reaching their target blood pressure according to the JNCVII criteria.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
multi-centre survey of patients

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

Responsible Party: AstraZeneca Identifier: NCT01274494     History of Changes
Other Study ID Numbers: NIS-CME-ATA-2010/1
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents