Clinical trial NCT00944489: To Assess Adherence to the Treatment and Quality of Life in Patients With Hypertension
Official title: Hypertension and Health-Related Quality of Life Adherence: Cross- Sectional Observational Study in Ambulatory Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Health-Related Quality of Life Adherence to the antihypertension treatment
Ambulatory Patients
MINICHAL score
Treatment Adherence Scale (MMAS)
Quality of life
Adherence to treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 1150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: clinic and private practice

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3-6 months
Secondary outcomes:
measure: Assess quality of life in patients in this cohort.
timeFrame: 3-6 months
measure: Identify associated factors that may alter adherence to antihypertensive treatment.
timeFrame: 3-6 months
measure: Know pharmacological groups used for this pathology and compare treatment adherence level according to the different therapeutic regimes used
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
Study officials:
References: