An interventional study of Omron 9200T plus Telemonitoring and Omron 9200T without Telemonitoring in Hypertension, sponsored by Universidad de la Republica. Withdrawn at 8 sites in 2 countries. Open to participants aged 20 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by Universidad de la Republica · Not applicable, Interventional, and Treatment
The proportion of hypertensive patients achieving adequate blood pressure control meeting guideline targets remains low. Of those patients on blood pressure lowering drugs, only 50% reach control.
Objectives:
Methods:
Randomised parallel-group study consisting of 4 stages.
Sample size: 120 patients per group. Patients: recruited at clinics from Uruguay and Argentina.
Main Inclusion Criteria:
Exclusion Criteria
Research Questions
Previous studies demonstrated the feasibility of telemonitoring of blood pressure. However, several issues remain unaddressed.
General Design
ERNESTINA is a randomised parallel-group study, which will address the feasibility and potential benefits of telemonitoring of blood pressure at home. Eligible patients will be recruited at outpatient medical clinics.
Eligible patients will be stratified by centre and randomised in a one-to-one proportion to control or intervention. Randomisation will be implemented by sequentially numbered sealed envelopes, which contain the group assignment. These envelopes will be available at the practices, so that no contact with the Studies Coordinating Centre (SCC) will be necessary to randomise the patient.
Primary endpoint
The primary endpoint will be the time to blood pressure control in the two randomised groups. Blood pressure control will be defined as a self-measured blood pressure at home below 135 mm Hg systolic and 85 mm Hg diastolic. Blood pressure control is assumed to be present if the aforementioned levels are attained during the week preceding the last office visit of the randomised treatment visit. Treatment resistance is a home blood pressure not controlled on 3 drugs classes given at maximal doses, preferably including a diuretic after 6 months of follow-up. These patients might be referred for further exploration and treatment adjustment to a hypertension centre.
Secondary endpoints
Secondary endpoints related to blood pressure control (efficacy) are:
Economic Analysis The cost-effectiveness analysis will include both the direct and indirect costs of the intervention. The costs will be balanced against the use of medical resources, including visits, medications, and use of medical resources.
Moreover, the incremental cost-effectiveness ratios (ICERs) will be calculated by dividing the net cost of intervention by the total incremental health care costs after the intervention according to the formula ICER = (Ci - Cc) / (Ei - Ec), where Ci and Cc and Ei and Ec are the costs and effectiveness associated with the intervention and usual care, respectively. Sensitivity analyses will examine the influence of uncertainty in the variables and assumptions. Model performance will be estimated through confidence intervals estimated in a probabilistic manner using Monte Carlo simulation.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
Browse Hypertension studies →Universidad de la Republica is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The clinical context is suboptimal for telemonitoring of blood pressure:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the control group doctors will receive information on the self-measured blood pressure as recorded at home via a diary card.
Device: Omron 9200T without Telemonitoring
In the intervention group, doctors will receive weekly reports via telemonitoring of self-measured blood pressure.
Device: Omron 9200T plus Telemonitoring
Telemonitoring of the self-measured blood pressure at home. After each blood pressure measurement the values are transmitted to and stored into a central station where a condensed weekly report is elaborated and delivered to the doctor (investigator).
Also known as: Telemonitored Self-BP Measurement
Self-measured blood pressure at home and register the values in a diary card. Participants will perform 2 consecutive blood pressure measurements twice a day for a 7 day period, previous to the visit to the doctor's (investigator) office.
Also known as: Conventional Self-BP Measurement
Time to blood pressure control
Blood pressure control will be defined as a self-measured blood pressure at home below 135 mm Hg systolic and 85 mm Hg diastolic. Blood pressure control is assumed to be present if the aforementioned levels are attained during the preceding week to medical control.
Time frame: through study completion, an average of 2 years
The proportion of patients reaching blood pressure control on self-measurement at home and office measurement
For each participant, the individual time frame is up-to 6 months. However, to know the proportion of patients we need to recruit at least 50% of the calculated sample. Blood pressure control on office measurement is an average (3 consecutive readings) blood pressure below 140 mm Hg systolic and 90 mm Hg. Blood pressure control on self-blood pressure measurement is an average (up to 28 readings) blood pressure below 135 mm Hg systolic and 85 mm Hg diastolic.
Time frame: through study completion, an average of 2 years
The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit
For each participant, the individual time frame is up-to 6 months. However, to know the proportion of patients we need to recruit at least 50% of the calculated sample. Blood pressure control on office measurement is an average (3 consecutive readings) blood pressure below 140 mm Hg systolic and 90 mm Hg. Blood pressure control on self-blood pressure measurement is an average (up to 28 readings) blood pressure below 135 mm Hg systolic and 85 mm Hg diastolic.
Time frame: through study completion, an average of 2 years
Total pill load per day
For each participant, the individual time frame is up-to 6 months. However, to know the proportion of patients we need to recruit at least 50% of the calculated sample. We will compute total pill load per day and number of single-pill combinations of anti-hypertensive medication at the moment of reaching blood pressure control or leaving the study.
Time frame: through study completion, an average of 2 years
Number of single-pill combinations
For each participant, the individual time frame is up-to 6 months. However, to know the proportion of patients we need to recruit at least 50% of the calculated sample. We will compute total pill load per day and number of single-pill combinations of anti-hypertensive medication at the moment of reaching blood pressure control or leaving the study.
Time frame: through study completion, an average of 2 years
Adverse events, recorded by a self-administered questionnaire
For each participant, the individual time frame is up-to 6 months. However, to know the proportion of patients we need to recruit at least 50% of the calculated sample.
Time frame: through study completion, an average of 2 years
Assessment of drug adherence using Morisky questionnaire
We will use Morisky questionaire to asses adherence to anti-hypertensive treatment
Time frame: through study completion, an average of 2 years
Assessment of quality of life using the Euro-Quality-of-life questionnaire "EQ-5D-5L"
Time frame: through study completion, an average of 2 years
Health care costs from randomization to last follow-up
For each participant, the individual time frame is up-to 6 months. However, to know the proportion of patients we need to recruit at least 50% of the calculated sample. Cost will include both the direct and indirect costs of the intervention. The costs will be balanced against the use of medical resources, including visits, medications, and use of medical resources. The incremental cost-effectiveness ratios (ICERs) will be calculated.
Time frame: through study completion, an average of 2 years
Plan to share: No
This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Universidad de la Republica