We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944489
First Posted: July 23, 2009
Last Update Posted: December 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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

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 ]

Secondary Outcome Measures:
  • Assess quality of life in patients in this cohort. [ Time Frame: 3-6 months ]
  • Identify associated factors that may alter adherence to antihypertensive treatment. [ Time Frame: 3-6 months ]
  • Know pharmacological groups used for this pathology and compare treatment adherence level according to the different therapeutic regimes used [ Time Frame: 3-6 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944489


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

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00944489     History of Changes
Other Study ID Numbers: NIS-CAR-ATA-2009/1
First Submitted: July 17, 2009
First Posted: July 23, 2009
Last Update Posted: December 7, 2010
Last Verified: December 2010

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