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
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
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014