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A Home-based Blood Pressure Monitoring Program to Promote Better Management of Hypertension

10. juni 2013 opdateret af: Tehran University of Medical Sciences

A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.

In this study the investigators aim to evaluate the effect of home-based blood pressure measurement with an electronic device on medication adherence and blood pressure control.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Adherence to treatment is disappointingly low among patients with chronic health disorders especially after 6 month of initiating drug therapy. In hypertensive patients , as reported by WHO, 50% of non-adherence could be expected. Poor adherence to anti hypertensive medications results in increased morbidity, mortality and costs. One of the reasons that could implicate medications adherence can be attributed to seeing no physical sign of better controlling blood pressure. Self monitoring of blood pressure at home has been reported to improve patients adherence to their medications.

This study is a 2-arm randomized controlled trial. The investigators aim to evaluate the effect of home-based blood pressure measurement with an electronic device on medication adherence and blood pressure status.

One hundred ninety six hypertensive patients aged at least 18 years old are recruited in an ambulatory care setting and are evenly allocated to the study arms with balanced-block telephone randomization.

Appropriate medication is prescribed as preferred by the cardiologist (single daily dose medicines are recommended). Patients in both arms are followed for 24 weeks, each will be visited by the cardiologist four times during the study period. In each visit, patients' blood pressure will be measured twice by a nurse in the office.

In the intervention arm, electronic blood pressure device is provided for each patient and he/she will be trained to measure blood pressure at home once daily (same time each day). A logbook is also provided to document the daily blood pressure level.

Primary outcome of the study is the blood pressure measured at each office visit overtime. Medication adherence is measured by pill count method as the secondary outcome.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

196

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Ambulatory patients older than 18
  • Patients newly diagnosed as hypertension stage 1
  • Patients previously on antihypertensive treatment but uncontrolled hypertension
  • Patients not possessing electronic self blood pressure measurement device
  • Patients with functional ability to use the device

Exclusion Criteria:

  • Patients requiring two or more antihypertensive drugs at the start of the study
  • Patients with secondary hypertension
  • Patients cardiovascular comorbidities and other interfering medical conditions
  • Patients with drug contraindication or documented drug allergy
  • Patients with serum creatinine > 150 microliters

Withdrawal criteria:

  • Inadequate therapeutic effect requiring an increase of more than 20% in pre-established number of visits
  • Emergence of adverse drug reactions requiring cessation of medication

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Home-based blood pressure monitoring
Adfærdsmæssigt: Self monitoring of blood pressure
Electronic blood pressure device is provided for patients and he/she will be trained to measure blood pressure at home once daily(same time each day). A logbook is also provided to document the daily blood pressure level.
Aktiv komparator: Sædvanlig pleje
Andet: Usual Care
Four visits to the physician's office at 4th, 12th, 24th week in the study period with usual advice giving practice of the staff. At the end of the trial period, an electronic blood pressure device will be given to each patient in this arm.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood pressure-24 weeks
Tidsramme: Change from baseline(at the point of recruiting) blood pressure at 24 weeks.
Blood pressure is measured twice by trained nurses using hand-cuff device at the physician office. (in Hg millimeter)
Change from baseline(at the point of recruiting) blood pressure at 24 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication adherence-4 weeks
Tidsramme: Change from baseline(at the point of recruiting) medication adherence at 4 weeks
Change from baseline(at the point of recruiting) medication adherence at 4 weeks
Blood pressure- 4 weeks
Tidsramme: Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
Blood pressure- 12 weeks
Tidsramme: Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
Medication adherence- 12 weeks
Tidsramme: Change from baseline(at the point of recruiting) medication adherence at 12 weeks
Change from baseline(at the point of recruiting) medication adherence at 12 weeks
Medication adherence-24 weeks
Tidsramme: Change from baseline(at the point of recruiting) medication adherence at 24 weeks
Pill count method is employed. At the time of each office visit, patients bring their medications with themselves and the researcher counts the unused pills. Adherence is calculated as percentage of the pills used during previous weeks.
Change from baseline(at the point of recruiting) medication adherence at 24 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Tehran University of Medical Sciences

Samarbejdspartnere

Research Center for Rational Use of Drugs

Efterforskere

  • Studiestol: Kheirollah Gholami, M.Sc,PharmD, Tehran University of Medical Sciences
  • Studieleder: Zahra Jahangard-Rafsanjani, PharmD, Tehran University of Medical Sciences
  • Ledende efterforsker: Arash Rashidian, M.D, Ph.D, Tehran University of Medical Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. marts 2012

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

30. januar 2012

Først indsendt, der opfyldte QC-kriterier

1. februar 2012

Først opslået (Skøn)

2. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 90-04-156-15281

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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