Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Research Center for Rational Use of Drugs | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based blood pressure monitoring | Experimental |
| |
| Usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure-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. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence-4 weeks | Change from baseline(at the point of recruiting) medication adherence at 4 weeks | |
| Blood pressure- 4 weeks | Change from baseline(at the point of recruiting) blood pressure at 4 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kheirollah Gholami, M.Sc,PharmD | Tehran University of Medical Sciences | Study Chair |
| Zahra Jahangard-Rafsanjani, PharmD | Tehran University of Medical Sciences | Study Director |
| Arash Rashidian, M.D, Ph.D | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Mohagheghi's Office | Tehran | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24771706 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Blood pressure- 12 weeks | Change from baseline(at the point of recruiting) blood pressure at 12 weeks. |
| Medication adherence- 12 weeks | Change from baseline(at the point of recruiting) medication adherence at 12 weeks |
| Medication adherence-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 |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |