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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Self monitoring of blood pressure; Other: Usual Care

• Registration Number: NCT01525108
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-02
• Study Start: 2012-03
• Primary Completion: 2012-09
• Study Completion: 2013-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based blood pressure monitoring	Self monitoring of blood pressure	-
Usual care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
Blood pressure-24 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Medication adherence-4 weeks	Change from baseline(at the point of recruiting) medication adherence at 4 weeks
Blood pressure- 12 weeks	Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
Blood pressure- 4 weeks	Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
Medication adherence- 12 weeks	Change from baseline(at the point of recruiting) medication adherence at 12 weeks
Medication adherence-24 weeks	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.

Trial Locations

Locations (1)

Dr Mohagheghi's Office; 🇮🇷 Tehran, Iran, Islamic Republic of