A Home-based Blood Pressure Monitoring Program to Promote Better Management of Hypertension
|ClinicalTrials.gov Identifier: NCT01525108|
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : June 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Self monitoring of blood pressure Other: Usual Care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||March 2013|
|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.
- 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)
- Medication adherence-4 weeks [ Time Frame: 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. ]
- Blood pressure- 12 weeks [ Time Frame: 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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525108
|Iran, Islamic Republic of|
|Dr Mohagheghi's Office|
|Tehran, Iran, Islamic Republic of|
|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|