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

Hypertension Clinical Trial

— ADHERENCE  

Official title:

Hypertension and Health-Related Quality of Life Adherence: Cross- Sectional Observational Study in Ambulatory Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944489
• Other study ID #: NIS-CAR-ATA-2009/1
• Status: Completed
• Phase: N/A
• First received: July 17, 2009
• Last updated: December 6, 2010
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assess quality of life in patients in this cohort.		3-6 months	No
Secondary	Identify associated factors that may alter adherence to antihypertensive treatment.		3-6 months	No
Secondary	Know pharmacological groups used for this pathology and compare treatment adherence level according to the different therapeutic regimes used		3-6 months	No