- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00944489
To Assess Adherence to the Treatment and Quality of Life in Patients With Hypertension (ADHERENCE)
Hypertension and Health-Related Quality of Life Adherence: Cross- Sectional Observational Study in Ambulatory Patients
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Buenos Aires, Argentina
- Research Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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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
Tidsramme: 3-6 months
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3-6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Assess quality of life in patients in this cohort.
Tidsramme: 3-6 months
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3-6 months
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Identify associated factors that may alter adherence to antihypertensive treatment.
Tidsramme: 3-6 months
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3-6 months
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Know pharmacological groups used for this pathology and compare treatment adherence level according to the different therapeutic regimes used
Tidsramme: 3-6 months
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3-6 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIS-CAR-ATA-2009/1
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