HypertensionMONITORNCT00921791
Efficacy of Home Blood Pressure Monitoring (MONITOR Study)
A study testing HBPM, HBPM and Pharmaceutical care and Pharmaceutical care in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
High blood pressure is the main risk factor for cardiovascular disease worldwide,but its control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic oscillometric devices and pharmaceutical care have been proposed as interventions to increase therapeutic compliance and to guide treatment… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- HBPM, HBPM and Pharmaceutical care and Pharmaceutical care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2006to Jun 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Office BP ≥140/90 mm Hg
- 24h ABPM hypertension BP ≥130/80 mm Hg
- using at least one antihypertensive drug
Who cannot join
- BP ≥ 180 / 110 mmHg)
- major cardiovascular events in the last six months
- acute or chronic diseases limiting the capacity to understand and to participate in the trial
- masked hypertension
- white-coat hypertension
- secondary hypertension
Show all 9Show fewer
- pregnancy
- breastfeeding
- concurrent participation in another trial
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement
High blood pressure is the main risk factor for cardiovascular disease worldwide,but its control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic oscillometric devices and pharmaceutical care have been proposed as interventions to increase therapeutic compliance and to guide treatment decisions.
The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).
Read the detailed description
Home Blood Pressure Monitoring (HBPM) and Pharmaceutical care have been proposed to improve therapeutic compliance and to guide treatment decisions, but their effects on BP control are still under debate.
This is a factorial randomized controlled trial including adult hypertensive patients under drug treatment but with office BP and 24h ABPM uncontrolled. Participants will be allocated to one of four groups: HBPM; HBPM and Pharmaceutical care; Pharmaceutical care; or control. All participants will receive usual care for high blood pressure. Participants will be followed for 60 days.
- Conditions
- Hypertension
- Being tested
- HBPM, HBPM and Pharmaceutical care, Pharmaceutical care, Usual care
- Keywords
- Hypertension, Blood pressure, Home Blood Pressure Monitoring, Ambulatory Blood Pressure Monitoring, Pharmaceutical care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBPMDevice
Automatic oscillometric device for home blood pressure measurement and usual care.
HBPM and Pharmaceutical careDevice
Also called HBPM
Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists
Pharmaceutical careBehavioural
Also called DADER method
consultations with the pharmacists
Usual careOther
Also called Usual clinical practice.
Consultation with the physician.
| Study group | Role | What they receive |
|---|---|---|
| Home Blood Pressure Monitoring | Experimental | Automatic oscillometric device for blood pressure measurement at home plus usual care. Receives: Device: HBPM |
| HBPM and Pharmaceutical care | Experimental | Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care. Receives: Device: HBPM and Pharmaceutical care |
| Pharmaceutical care | Active comparator | Consultations with the pharmacists plus usual care. Receives: Behavioral: Pharmaceutical care |
| Control | Active comparator | Usual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta values for 24h ABPM between baseline and final ABPM measurements
Measured: 60 days
Secondary outcomes (2)
Hypertension control
Measured: 60 days
Average of systolic and diastolic blood pressure at the end of the study.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startApr 2006
- Primary completionJan 2009
- Study completionJun 2009
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.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Federal University of Health Science of Porto Alegre
- Investigators
- Sandra C. Fuchs, MD, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921791
- Sponsor's protocol ID
- GPPG 04465
- Acronym
- MONITOR
- Status last verified
- Jun 2009
- First submitted
- 15 Jun 2009
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Fuchs SC, Ferreira-da-Silva AL, Moreira LB, Neyeloff JL, Fuchs FC, Gus M, Wiehe M, Fuchs FD. Efficacy of isolated home blood pressure monitoring for blood pressure control: randomized controlled trial with ambulatory blood pressure monitoring - MONITOR study. J Hypertens. 2012 Jan;30(1):75-80. doi: 10.1097/HJH.0b013e32834e5a4f.
PubMed 22134392
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement
- ClinicalTrials.gov ID
- NCT00921791
- Acronym / sponsor ID
- MONITOR / GPPG 04465
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure, Home Blood Pressure Monitoring, Ambulatory Blood Pressure Monitoring, Pharmaceutical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Federal University of Health Science of Porto Alegre
- Study start
- Apr 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Jun 2009 (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.
High blood pressure is the main risk factor for cardiovascular disease worldwide,but its control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic oscillometric devices and pharmaceutical care have been proposed as interventions to increase therapeutic compliance and to guide treatment decisions.
The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).
Detailed description
Home Blood Pressure Monitoring (HBPM) and Pharmaceutical care have been proposed to improve therapeutic compliance and to guide treatment decisions, but their effects on BP control are still under debate.
This is a factorial randomized controlled trial including adult hypertensive patients under drug treatment but with office BP and 24h ABPM uncontrolled. Participants will be allocated to one of four groups: HBPM; HBPM and Pharmaceutical care; Pharmaceutical care; or control. All participants will receive usual care for high blood pressure. Participants will be followed for 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Home Blood Pressure Monitoring | Experimental | Device: HBPMAutomatic oscillometric device for blood pressure measurement at home plus usual care. |
| HBPM and Pharmaceutical care | Experimental | Device: HBPM and Pharmaceutical careAutomatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care. |
| Pharmaceutical care | Active comparator | Behavioral: Pharmaceutical careConsultations with the pharmacists plus usual care. |
| Control | Active comparator | Other: Usual careUsual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Office BP ≥140/90 mm Hg
- 24h ABPM hypertension BP ≥130/80 mm Hg
- using at least one antihypertensive drug
Key exclusion criteria (9 listed)
- BP ≥ 180 / 110 mmHg)
- major cardiovascular events in the last six months
- acute or chronic diseases limiting the capacity to understand and to participate in the trial
- masked hypertension
- white-coat hypertension
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 |
|---|---|---|
| HBPMAutomatic oscillometric device for home blood pressure measurement and usual care. | Device | Home Blood Pressure Monitoring |
| HBPM and Pharmaceutical careAlso: HBPMAutomatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists | Device | HBPM and Pharmaceutical care |
| Pharmaceutical careAlso: DADER methodconsultations with the pharmacists | Behavioural | Pharmaceutical care |
| Usual careAlso: Usual clinical practice.Consultation with the physician. | Other | Control |
Primary outcome
Delta values for 24h ABPM between baseline and final ABPM measurements
Time frame: 60 days
2 secondary outcomes
Hypertension control
Time frame: 60 days
Average of systolic and diastolic blood pressure at the end of the study.
Time frame: 60 days
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 16 Jun 2009.
- Derived from this study: PubMed 22134392Fuchs SC, Ferreira-da-Silva AL, Moreira LB, Neyeloff JL, Fuchs FC, Gus M, Wiehe M, Fuchs FD. Efficacy of isolated home blood pressure monitoring for blood pressure control: randomized controlled trial with ambulatory blood pressure monitoring - MONITOR study. J Hypertens. 2012 Jan;30(1):75-80. doi: 10.1097/HJH.0b013e32834e5a4f.
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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.
Sandra C. Fuchs, MD, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBPM, HBPM and Pharmaceutical care and Pharmaceutical care in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 inclusion and 9 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 16 Jun 2009. 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 Brazil. 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?
Delta values for 24h ABPM between baseline and final ABPM measurements (time frame: 60 days). 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 NCT00921791, 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 16 Jun 2009.