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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home-based blood pressure monitoring

Group Type EXPERIMENTAL

Self monitoring of blood pressure

Intervention Type BEHAVIORAL

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.

Usual care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No