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

June 10, 2013 updated by: Tehran University of Medical Sciences

A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based blood pressure monitoring
Behavioral: 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.
Active Comparator: Usual care
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure-24 weeks
Time Frame: 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)
Change from baseline(at the point of recruiting) blood pressure at 24 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence-4 weeks
Time Frame: Change from baseline(at the point of recruiting) medication adherence at 4 weeks
Change from baseline(at the point of recruiting) medication adherence at 4 weeks
Blood pressure- 4 weeks
Time Frame: Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
Blood pressure- 12 weeks
Time Frame: Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
Medication adherence- 12 weeks
Time Frame: Change from baseline(at the point of recruiting) medication adherence at 12 weeks
Change from baseline(at the point of recruiting) medication adherence at 12 weeks
Medication adherence-24 weeks
Time Frame: 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.
Change from baseline(at the point of recruiting) medication adherence at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Collaborators

Research Center for Rational Use of Drugs

Investigators

  • Study Chair: Kheirollah Gholami, M.Sc,PharmD, Tehran University of Medical Sciences
  • Study Director: Zahra Jahangard-Rafsanjani, PharmD, Tehran University of Medical Sciences
  • Principal Investigator: Arash Rashidian, M.D, Ph.D, Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 30, 2012

First Submitted That Met QC Criteria

February 1, 2012

First Posted (Estimate)

February 2, 2012

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90-04-156-15281

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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