Clinical trial NCT01525108: A Home-based Blood Pressure Monitoring Program to Promote Better Management of Hypertension
Official title: A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Medication adherence
Blood pressure
Home-based blood pressure measurement
Blood Pressure Determination
Blood Pressure Monitors
Blood Pressure Monitoring, Ambulatory
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Research Center for Rational Use of Drugs
First posted: 2012-02-02
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Blood pressure-24 weeks
timeFrame: Change from baseline(at the point of recruiting) blood pressure at 24 weeks.
Secondary outcomes:
measure: Medication adherence-4 weeks
timeFrame: Change from baseline(at the point of recruiting) medication adherence at 4 weeks
measure: Blood pressure- 4 weeks
timeFrame: Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
measure: Blood pressure- 12 weeks
timeFrame: Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
measure: Medication adherence- 12 weeks
timeFrame: Change from baseline(at the point of recruiting) medication adherence at 12 weeks
measure: Medication adherence-24 weeks
timeFrame: Change from baseline(at the point of recruiting) medication adherence at 24 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Dr Mohagheghi's Office
Study officials:
affiliation: Tehran University of Medical Sciences
name: Kheirollah Gholami, M.Sc,PharmD
role: STUDY_CHAIR
affiliation: Tehran University of Medical Sciences
name: Zahra Jahangard-Rafsanjani, PharmD
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Arash Rashidian, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hosseininasab M, Jahangard-Rafsanjani Z, Mohagheghi A, Sarayani A, Rashidian A, Javadi M, Ahmadvand A, Hadjibabaie M, Gholami K. Self-monitoring of blood pressure for improving adherence to antihypertensive medicines and blood pressure control: a randomized controlled trial. Am J Hypertens. 2014 Nov;27(11):1339-45. doi: 10.1093/ajh/hpu062. Epub 2014 Apr 26.