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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tehran, Irán (República Islámica de
- Dr Mohagheghi's Office
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: Cuidado usual
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood pressure-24 weeks
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Medication adherence-4 weeks
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Kheirollah Gholami, M.Sc,PharmD, Tehran University of Medical Sciences
- Director de estudio: Zahra Jahangard-Rafsanjani, PharmD, Tehran University of Medical Sciences
- Investigador principal: Arash Rashidian, M.D, Ph.D, Tehran University of Medical Sciences
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 90-04-156-15281
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