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Completed

NCT Number: NCT01525108

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Mohagheghi's Office

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self monitoring of blood pressure

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

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Medication adherence-4 weeks

    Time frame: Change from baseline(at the point of recruiting) medication adherence at 4 weeks

  2. Blood pressure- 4 weeks

    Time frame: Change from baseline(at the point of recruiting) blood pressure at 4 weeks.

  3. Blood pressure- 12 weeks

    Time frame: Change from baseline(at the point of recruiting) blood pressure at 12 weeks.

  4. Medication adherence- 12 weeks

    Time frame: Change from baseline(at the point of recruiting) medication adherence at 12 weeks

  5. 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.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Research Center for Rational Use of Drugs

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Feb 2, 2012
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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