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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01274494
First received: January 10, 2011
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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
High Blood Pressure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Compliance rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Identify the percentage of subjects compliant to their antihypertensive treatment.


Secondary Outcome Measures:
  • Health Related Quality of Life (MINICHAL Score) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To compare and identify changes in the quality of life before and after anti-hypertensive treatment.

  • Type of pharmacological treatments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To identify the pharmacological treatments used by physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension.

  • Factors affecting adherence to treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To identify associated factors that may alter adherence to anti-hypertensive treatment.

  • Compliance rate by antihypertensive regimen used [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To compare treatment rate for different antihypertensive regimen used

  • Percentage of controlled patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To identify the percentage of patients reaching their target blood pressure according to the JNCVII criteria.


Enrollment: 1501
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

multi-centre survey of patients

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01274494     History of Changes
Other Study ID Numbers: NIS-CME-ATA-2010/1
Study First Received: January 10, 2011
Last Updated: September 10, 2013
Health Authority: Jordan: Ethical Committee
Lebanon: Institutional Review Board

Keywords provided by AstraZeneca:
Hypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014