A Home-based Blood Pressure Monitoring Program to Promote Better Management of Hypertension
A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Tehran, Írán, Islámská republika
- Dr Mohagheghi's Office
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Home-based blood pressure monitoring
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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.
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Aktivní komparátor: Obvyklá péče
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Blood pressure-24 weeks
Časové okno: Change from baseline(at the point of recruiting) blood pressure at 24 weeks.
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Blood pressure is measured twice by trained nurses using hand-cuff device at the physician office.
(in Hg millimeter)
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Change from baseline(at the point of recruiting) blood pressure at 24 weeks.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Medication adherence-4 weeks
Časové okno: Change from baseline(at the point of recruiting) medication adherence at 4 weeks
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Change from baseline(at the point of recruiting) medication adherence at 4 weeks
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Blood pressure- 4 weeks
Časové okno: Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
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Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
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Blood pressure- 12 weeks
Časové okno: Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
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Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
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Medication adherence- 12 weeks
Časové okno: Change from baseline(at the point of recruiting) medication adherence at 12 weeks
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Change from baseline(at the point of recruiting) medication adherence at 12 weeks
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Medication adherence-24 weeks
Časové okno: Change from baseline(at the point of recruiting) medication adherence at 24 weeks
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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.
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Change from baseline(at the point of recruiting) medication adherence at 24 weeks
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Kheirollah Gholami, M.Sc,PharmD, Tehran University of Medical Sciences
- Ředitel studie: Zahra Jahangard-Rafsanjani, PharmD, Tehran University of Medical Sciences
- Vrchní vyšetřovatel: Arash Rashidian, M.D, Ph.D, Tehran University of Medical Sciences
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 90-04-156-15281
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