To Assess Adherence to the Treatment and Quality of Life in Patients With Hypertension (ADHERENCE)
|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.|
|ClinicalTrials.gov Identifier: NCT00944489|
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : December 7, 2010
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:
- 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.
- 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 or disease|
|Study Type :||Observational|
|Actual Enrollment :||1150 participants|
|Official Title:||Hypertension and Health-Related Quality of Life Adherence: Cross- Sectional Observational Study in Ambulatory Patients|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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.
- 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 ]
- 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 ]
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
|Buenos Aires, Argentina|