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

This study has been completed.
Sponsor:
Collaborator:
Research Center for Rational Use of Drugs
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01525108
First received: January 30, 2012
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Self monitoring of blood pressure
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Blood pressure-24 weeks [ Time Frame: Change from baseline(at the point of recruiting) blood pressure at 24 weeks. ] [ Designated as safety issue: No ]
    Blood pressure is measured twice by trained nurses using hand-cuff device at the physician office. (in Hg millimeter)


Secondary Outcome Measures:
  • Medication adherence-4 weeks [ Time Frame: Change from baseline(at the point of recruiting) medication adherence at 4 weeks ] [ Designated as safety issue: No ]
  • Blood pressure- 4 weeks [ Time Frame: Change from baseline(at the point of recruiting) blood pressure at 4 weeks. ] [ Designated as safety issue: No ]
  • Blood pressure- 12 weeks [ Time Frame: Change from baseline(at the point of recruiting) blood pressure at 12 weeks. ] [ Designated as safety issue: No ]
  • Medication adherence- 12 weeks [ Time Frame: Change from baseline(at the point of recruiting) medication adherence at 12 weeks ] [ Designated as safety issue: No ]
  • Medication adherence-24 weeks [ Time Frame: Change from baseline(at the point of recruiting) medication adherence at 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 196
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525108

Locations
Iran, Islamic Republic of
Dr Mohagheghi's Office
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
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
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01525108     History of Changes
Other Study ID Numbers: 90-04-156-15281
Study First Received: January 30, 2012
Last Updated: June 10, 2013
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Medication adherence
Blood pressure
Home-based blood pressure measurement
Blood Pressure Determination
Blood Pressure Monitors
Blood Pressure Monitoring, Ambulatory

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014