Telemonitoring of Uncontrolled Hypertension (ERNESTINA)

January 30, 2019 updated by: José Boggia, Universidad de la Republica

Estudio RioplateNsE Sobre Telemonitoreo en hIpertensos No-controlAdos

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:

  1. Test the feasibility of telemonitoring of blood pressure in uncontrolled hypertensive patients.
  2. Investigate whether telemonitoring enabled self-measurement of blood pressure leads to faster blood pressure control than self-measurement without telemonitoring.
  3. Secondary endpoints include adverse effects, assessment of quality of life, adherence, a log of technical problems, and cost-effectiveness.

Methods:

Randomised parallel-group study consisting of 4 stages.

  • Screening to check for eligibility.
  • Randomisation in a 1:1 proportion to control or experimental arm: In the control arm, doctors will receive reports on the self-measured blood pressure based on diary cards; in the experimental group, doctors will receive weekly reports via telemonitoring.
  • Treatment period: Doctors will adjust treatment according to the present guidelines of Hypertension. Blood pressure control is a home blood pressure below 135 mm Hg systolic and 85 mm Hg diastolic. Once blood pressure control is achieved the treatment period ends.
  • Late follow-up: Assessment of blood pressure control at home 3 months after completion of the treatment period by means of telemonitoring.

Sample size: 120 patients per group. Patients: recruited at clinics from Uruguay and Argentina.

Main Inclusion Criteria:

  • Women and men, age range 20 to 80 years.
  • Uncontrolled hypertension and new diagnosed hypertension with a self-measured blood pressure at home of 135 mm Hg systolic and/or 85 mm Hg diastolic or more;
  • Patients should be willing to accept adherence checking during follow-up and sign an informed written consent.

Exclusion Criteria

  • Patients emotionally or intellectually not capable of measuring their blood pressure at home;
  • A clinical or social context, which is suboptimal for the self-measurement of blood pressure;
  • Pregnancy;
  • Alcohol or substance abuse or psychiatric illnesses;
  • Participation in another study. Expected outcomes: blood pressure control will be achieved faster in the telemonitoring group.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

  1. Research Questions

    Previous studies demonstrated the feasibility of telemonitoring of blood pressure. However, several issues remain unaddressed.

    • Feasibility of telemonitoring within the South American context has never been tested. No attempt has ever been made in South America to assess adherence to antihypertensive drugs in primary care.
    • Telemonitoring of blood pressure will never make it to the routine clinical practice unless it can be proven that application of the technique results in faster and better blood pressure control compared with usual care including self-measurement of blood pressure at home.
    • Secondary endpoints must also include adverse events, a simple assessment of quality of life, adherence, a log of technical problems, and cost-effectiveness.

  2. 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.

    - Screening period followed by stratification and randomisation: Screening involves checking inclusion and exclusion criteria, ruling out secondary hypertension remediable by specific treatment, and obtaining informed written consent as outlined in the Helsinki declaration.

    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.

    - Randomised period: Investigators will optimise medical treatment by rotating patients through different classes of antihypertensive drugs, combining drug classes according to the current guidelines of the Argentinian and European Societies of Hypertension (SAHA and ESH), while achieving the maximal tolerated dose of each drug. In the intervention group, investigators will receive a report on the telemonitoring data at weekly intervals; in the control group doctors will receive information on the self-measured blood pressure as recorded at home in the week preceding the office visit via a diary card. Doctors are free to schedule contacts with their patients and office visits at their own discretion but visits should be at least every 3 weeks. Once blood pressure control is achieved, the blood pressure measuring devices (telemonitoring enabled or not) will be recuperated and will become available for a next patient. In the control group, patients will keep a diary card in the week preceding the office visits.

    - Late follow-up: Three months after achieving blood pressure control, all patients will be telemonitored for 1 week and complete a diary card, preceding an office visit.

  3. Primary and Secondary Endpoints

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:

  • The proportion of patients reaching blood pressure control on self-measurement at home and office measurement; Blood pressure control on office measurement is a seated blood pressure below 140 mm Hg systolic and 90 mm Hg;
  • The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit;
  • The intensity of medical treatment;
  • Adverse events, recorded by a self-administered questionnaire.
  • Assessment of drug adherence;
  • Assessment of quality of life;
  • Analysis of cost-effectiveness.

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Center AR-1
      • Buenos Aires, Argentina
        • Center AR-2
    • Cordoba
      • Ciudad de Cordoba, Cordoba, Argentina
        • Center AR-4
    • Santa-Fe
      • Rosario, Santa-Fe, Argentina
        • Center AR-3
  • Uruguay
      • Montevideo, Uruguay, 11600
        • Center UY-1
      • Montevideo, Uruguay, 11600
        • Center UY-2
      • Montevideo, Uruguay, 11600
        • Center UY-3
      • Montevideo, Uruguay, 11600
        • Center UY-4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Women and men are eligible. Women of reproductive age should apply effective contraception.
  2. Age ranges from 20 years (inclusive) to 80 years.
  3. At screening, patients should have hypertension, which is uncontrolled on medical treatment. Uncontrolled hypertension is an office blood pressure of 140 mm Hg systolic or 90 mm Hg diastolic or higher AND a self-measured blood pressure at home of 135 mm Hg systolic or 85 mm Hg diastolic or more. Practitioners will receive a weekly report on the self-measured blood pressure at home summarising the results of the run-in period.
  4. At the screening visit, patients should either be untreated for at least 4 weeks or taking a stable drug regimen for at least 4 weeks. Medical treatment can consist of all major drug classes. This includes diuretics, beta-blockers, alfa-blockers, calcium-channel blockers (CCBs), inhibitors of the renin system (angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II type 1 receptor blockers (ARBs), the direct renin inhibitor aliskiren,18 aldosterone receptor antagonists (ARAs), centrally acting antihypertensive drugs and vasodilators (hydralazine). In line with current recommendations and recent studies, unless contra-indicated or not tolerated, aldosterone antagonists, such as spironolactone 25 to 50 mg per day should have been attempted for at least 4 weeks to improve blood pressure control in treatment-resistant patients. (1) The patients should be intellectually and emotionally capable of measuring their blood pressure at home and accept to keep a diary (control group) or to have a report sent to their doctor (intervention group).
  5. Patient should provide written informed consent.

Exclusion Criteria:

  1. The clinical context is suboptimal for telemonitoring of blood pressure:

    • Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening period;
    • Type 1 diabetes mellitus requiring multiple adjustments of treatment to maintain control or diabetes mellitus with recent hyperglycaemic or hypoglycaemic coma;
    • Renal dysfunction defined as an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2, using the Modification of Diet in Renal Disease formula;
    • Secondary hypertension, in which treatment options other than antihypertensive drug treatment are indicated;
    • Sleep apnea syndrome that qualifies for treatment with continuous positive airway pressure (CPAP);
    • Atrial fibrillation or arrhythmia making oscillometric blood pressure measurement unreliable;
    • The patient is on a waiting list for elective surgery or a cardiovascular intervention;
    • Patients with alcohol or substance abuse or psychiatric illnesses.
  2. The patients should not have any serious medical condition, which in the opinion of the investigator, may adversely interfere with self-measurement of blood pressure at home.
  3. Patients should not participate in any other trial of an investigational drug or device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omron 9200T without Telemonitoring
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
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.
Other Names:
  • Conventional Self-BP Measurement
Experimental: Omron 9200T plus 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).
Other Names:
  • Telemonitored Self-BP Measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to blood pressure control
Time Frame: through study completion, an average of 2 years
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.
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients reaching blood pressure control on self-measurement at home and office measurement
Time Frame: through study completion, an average of 2 years

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.
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
Time Frame: through study completion, an average of 2 years

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.
through study completion, an average of 2 years
Total pill load per day
Time Frame: through study completion, an average of 2 years

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.
through study completion, an average of 2 years
Number of single-pill combinations
Time Frame: through study completion, an average of 2 years

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.
through study completion, an average of 2 years
Adverse events, recorded by a self-administered questionnaire
Time Frame: through study completion, an average of 2 years
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.
through study completion, an average of 2 years
Assessment of drug adherence using Morisky questionnaire
Time Frame: through study completion, an average of 2 years
We will use Morisky questionaire to asses adherence to anti-hypertensive treatment
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
through study completion, an average of 2 years
Health care costs from randomization to last follow-up
Time Frame: through study completion, an average of 2 years

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.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de la Republica

Collaborators

Hospital Italiano de Buenos Aires
KU Leuven

Investigators

  • Principal Investigator: Jose G Boggia, MD PhD, Universidad de la Republica - Uruguay

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 28, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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