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

Tehran University of Medical Sciences

Status

Completed

Conditions

Hypertension

Treatments

Behavioral: Self monitoring of blood pressure

Other: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT01525108

90-04-156-15281

Details and patient eligibility

About

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.

Full description

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.

Enrollment

196 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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