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

High Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274494
• Other study ID #: NIS-CME-ATA-2010/1
• Status: Completed
• Phase: N/A
• First received: January 10, 2011
• Last updated: September 10, 2013
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Ethical CommitteeLebanon: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1501
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance rate	Identify the percentage of subjects compliant to their antihypertensive treatment.	6 months	No
Secondary	Health Related Quality of Life (MINICHAL Score)	To compare and identify changes in the quality of life before and after anti-hypertensive treatment.	6 months	No
Secondary	Type of pharmacological treatments	To identify the pharmacological treatments used by physicians in Jordan and Lebanon to treat patients newly diagnosed or with uncontrolled hypertension.	6 months	No
Secondary	Factors affecting adherence to treatment	To identify associated factors that may alter adherence to anti-hypertensive treatment.	6 months	No
Secondary	Compliance rate by antihypertensive regimen used	To compare treatment rate for different antihypertensive regimen used	6 months	No
Secondary	Percentage of controlled patients	To identify the percentage of patients reaching their target blood pressure according to the JNCVII criteria.	6 months	No