HypertensionNCT01525108
A Home-based Blood Pressure Monitoring Program to Promote Better Management of Hypertension
A study testing Self monitoring of blood pressure in people with Hypertension, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Self monitoring of blood pressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteIran
- Study dates
- Mar 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Self monitoring of blood pressure, Usual Care
- Keywords
- Medication adherence, Blood pressure, Home-based blood pressure measurement, Blood Pressure Determination, Blood Pressure Monitors, Blood Pressure Monitoring, Ambulatory
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self monitoring of blood pressureBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based blood pressure monitoring | Experimental | Not described Receives: Behavioral: Self monitoring of blood pressure |
| Usual care | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure-24 weeks
Blood pressure is measured twice by trained nurses using hand-cuff device at the physician office. (in Hg millimeter)
Measured: Change from baseline(at the point of recruiting) blood pressure at 24 weeks.
Secondary outcomes (5)
Medication adherence-4 weeks
Measured: Change from baseline(at the point of recruiting) medication adherence at 4 weeks
Blood pressure- 4 weeks
Measured: Change from baseline(at the point of recruiting) blood pressure at 4 weeks.
Blood pressure- 12 weeks
Measured: Change from baseline(at the point of recruiting) blood pressure at 12 weeks.
Medication adherence- 12 weeks
Measured: 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.
Measured: Change from baseline(at the point of recruiting) medication adherence at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center for Rational Use of Drugs
- Responsible party
- Sponsor
- Investigators
- Kheirollah Gholami, M.Sc,PharmD, Study chair, Tehran University of Medical SciencesZahra Jahangard-Rafsanjani, PharmD, Study director, Tehran University of Medical SciencesArash Rashidian, M.D, Ph.D, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525108
- Sponsor's protocol ID
- 90-04-156-15281
- Status last verified
- Jun 2013
- First submitted
- 30 Jan 2012
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24771706
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-based Blood Pressure Measurement Program in Hypertensive Patients to Promote Medications Adherence and Blood Pressure Status.
- ClinicalTrials.gov ID
- NCT01525108
- Acronym / sponsor ID
- 90-04-156-15281
- Conditions
- Hypertension
- Keywords
- Medication adherence, Blood pressure, Home-based blood pressure measurement, Blood Pressure Determination, Blood Pressure Monitors, Blood Pressure Monitoring, Ambulatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Research Center for Rational Use of Drugs
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based blood pressure monitoring | Experimental | Behavioral: Self monitoring of blood pressure |
| Usual care | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self monitoring of blood pressureElectronic 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. | Behavioural | Home-based blood pressure monitoring |
| Usual CareFour 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. | Other | Usual care |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
- Derived from this study: PubMed 24771706Hosseininasab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kheirollah Gholami, M.Sc,PharmD study chair
Tehran University of Medical Sciences
Zahra Jahangard-Rafsanjani, PharmD study director
Tehran University of Medical Sciences
Arash Rashidian, M.D, Ph.D principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self monitoring of blood pressure in people with Hypertension, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure-24 weeks (time frame: Change from baseline(at the point of recruiting) blood pressure at 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01525108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2013.