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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00944489
First received: July 17, 2009
Last updated: December 6, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypertension and Health-Related Quality of Life Adherence: Cross- Sectional Observational Study in Ambulatory Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess quality of life in patients in this cohort. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • Identify associated factors that may alter adherence to antihypertensive treatment. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • Know pharmacological groups used for this pathology and compare treatment adherence level according to the different therapeutic regimes used [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Enrollment: 1150
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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 least the last 6 months.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

clinic and private practice

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944489

Locations
Argentina
Research Site
Buenos Aires, Argentina
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00944489     History of Changes
Other Study ID Numbers: NIS-CAR-ATA-2009/1
Study First Received: July 17, 2009
Last Updated: December 6, 2010
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by AstraZeneca:
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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013