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OpenTrials
Completed

NCT Number: NCT00944489

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Assess quality of life in patients in this cohort.

    Time frame: 3-6 months

  2. Identify associated factors that may alter adherence to antihypertensive treatment.

    Time frame: 3-6 months

  3. Know pharmacological groups used for this pathology and compare treatment adherence level according to the different therapeutic regimes used

    Time frame: 3-6 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ADHERENCE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 23, 2009
Registry last updated
Dec 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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