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

6. december 2010 opdateret af: AstraZeneca

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:

  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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Buenos Aires, Argentina
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

clinic and private practice

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
3-6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Assess quality of life in patients in this cohort.
Tidsramme: 3-6 months
3-6 months
Identify associated factors that may alter adherence to antihypertensive treatment.
Tidsramme: 3-6 months
3-6 months
Know pharmacological groups used for this pathology and compare treatment adherence level according to the different therapeutic regimes used
Tidsramme: 3-6 months
3-6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2009

Primær færdiggørelse (Faktiske)

1. januar 2010

Studieafslutning (Faktiske)

1. januar 2010

Datoer for studieregistrering

Først indsendt

17. juli 2009

Først indsendt, der opfyldte QC-kriterier

22. juli 2009

Først opslået (Skøn)

23. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. december 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. december 2010

Sidst verificeret

1. december 2010

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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