To Assess Adherence to the Treatment and Quality of Life in Patients With Hypertension (ADHERENCE)
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||August 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944489
|Buenos Aires, Argentina|