To Assess Adherence to the Treatment and Quality of Life in Patients With Hypertension

Completed

• Conditions: Hypertension

• Registration Number: NCT00944489
• Lead Sponsor: AstraZeneca

Brief Summary

The main goal of this study is to achieve a deeper knowledge of the adherence to antihypertensive drug treatment and to evaluate the quality of life in this population. This work has the following goals: primary objective is to assess the antihypertensive treatment adherence in patients with essential hypertension on treatment for more than 6 months.

The secondary objectives include the assessment of quality of life, identification of associated factors that affect adherence, knowledge of drugs used and comparison of levels of adherence according to the different drug regimes

Two questionnaires shall be prepared The first questionnaire shall be anonymously completed by the patient willing to participate. It is divided into two parts:

1. Treatment Adherence Scale (MMAS): this survey is made up of 4 questions having YES/No answers and it grants 1 point per every "NO" answer, and zero points to every "YES" answer.

2. The second part is the health-related quality of life Questionnaire (MINICHAL). The questions refer to the "last 7 days" with 4 possible answer options: 0 (no, absolutely not), 1 (yes, sometimes), 2 (yes, frequently) and 3 (yes, a lot). It is made up of 16 items, 10 correspond to the "State of Mind" dimension and 6 to the "Body-related Symptoms," also described as "Physical symptoms".

The second questionnaire shall be completed by the intervening physician as regards patients that attend medical visits, and who have answered the anonymous questionnaire.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-17
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Study Start: 2009-08
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

• Patients with diagnosis of essential hypertension under the criteria established by the Joint National Committee VII (9) and those patients under pharmacological treatment with the same therapeutic regime during at le

Exclusion Criteria

• Patients with secondary HBP
• Pregnant women or nursing mothers
• Patients with acute illnesses or having a definite psychiatric diagnosis, as well as those patients who are unable to completed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First questionnaires for patient:Treatment Adherence Scale, and the health-related quality of life Questionnaire .the intervening physician completed second questionnaire with all about the non and pharmacology treatment	3-6 months

Secondary Outcome Measures

Name	Time	Method
Assess quality of life in patients in this cohort.	3-6 months
Identify associated factors that may alter adherence to antihypertensive treatment.	3-6 months
Know pharmacological groups used for this pathology and compare treatment adherence level according to the different therapeutic regimes used	3-6 months

Trial Locations

Locations (1)

Research Site; 🇦🇷 Buenos Aires, Argentina