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Trial record 3 of 3 for:    12502614 [PUBMED-IDS]

Telemonitoring of Uncontrolled Hypertension (ERNESTINA)

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ClinicalTrials.gov Identifier: NCT02730052
Recruitment Status : Not yet recruiting
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Collaborators:
Hospital Italiano de Buenos Aires
KU Leuven
Information provided by (Responsible Party):
José Boggia, Universidad de la Republica

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hypertension Device: Omron 9200T plus Telemonitoring Device: Omron 9200T without Telemonitoring Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Estudio RioplateNsE Sobre Telemonitoreo en hIpertensos No-controlAdos
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

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 Name: 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 Name: Telemonitored Self-BP Measurement




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.

  6. 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

  7. 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 ]
  8. 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.




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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730052


Contacts
Contact: Jose G Boggia, MD PhD +59 8 2487 1515 ext 2567 jboggia@hc.edu.uy
Contact: Gabriel D Waisman, MD +54 11 4959 0200 gabriel.waisman@hospitalitaliano.org.ar

Locations
Argentina
Center AR-4 Not yet recruiting
Ciudad de Cordoba, Cordoba, Argentina
Contact: Marcelo Orias, MD, PhD    +54 935 1617 8890    marcelo.orias@gmail.com   
Principal Investigator: Marcelo Orias, MD         
Sub-Investigator: Roxana Mondino, MD         
Center AR-3 Not yet recruiting
Rosario, Santa-Fe, Argentina
Contact: Daniel Piskorz, MD       danielpiskorz@ciudad.com.ar   
Principal Investigator: Daniel Piskorz, MD         
Center AR-1 Not yet recruiting
Buenos Aires, Argentina
Contact: Jessica Barochiner, MD    +54 11 4959 0200    jessica.barochiner@hospitalitaliano.org.ar   
Contact: Lucas Aparicio, MD    +54 11 4959 0200    lucas.aparicio@hospitalitaliano.org.ar   
Principal Investigator: Gabriel D Waisman, MD         
Sub-Investigator: Paula Cuffaro, MD         
Sub-Investigator: Lucas Aparicio, MD         
Sub-Investigator: Jessica Barochiner, MD         
Sub-Investigator: Marcos Marin, MD         
Center AR-2 Not yet recruiting
Buenos Aires, Argentina
Contact: Judith Zilberman, MD    +54 911 5004 5420    juzilberman@gmail.com   
Principal Investigator: Judith Zilberman, MD         
Uruguay
Center UY-1 Not yet recruiting
Montevideo, Uruguay, 11600
Contact: Jose Boggia, MD PhD    + 598 9919 1146    jboggia@hc.edu.uy   
Contact: Oscar Noboa, Prof.    +59 8 9960 5122    onoboa@hc.edu.uy   
Center UY-2 Not yet recruiting
Montevideo, Uruguay, 11600
Contact: Ricardo Silvariño, MD    +59 8 99619401    rsilvarino@gmail.com   
Center UY-3 Not yet recruiting
Montevideo, Uruguay, 11600
Contact: Oscar A Noboa, MD    +59 8 24809850    onoboa@hc.edu.uy   
Principal Investigator: Washington Vignolo, MD         
Principal Investigator: Oscar A Noboa, MD         
Center UY-4 Not yet recruiting
Montevideo, Uruguay, 11600
Contact: Washington Vignolo, MD    099191146    wvignolo@gmail.com   
Principal Investigator: Bernardo Layerle, MD         
Principal Investigator: Washington Vignolo, MD         
Sponsors and Collaborators
Universidad de la Republica
Hospital Italiano de Buenos Aires
KU Leuven
Investigators
Principal Investigator: Jose G Boggia, MD PhD Universidad de la Republica - Uruguay

Publications:
41st World Medical Assembly. Declaration of Helsinki : recommendations guiding physicians in biomedical research involving human subjects. Bull Pan Am Health Organ 1990; 24: 606-609

Responsible Party: José Boggia, MD PhD, Universidad de la Republica
ClinicalTrials.gov Identifier: NCT02730052     History of Changes
Other Study ID Numbers: 11/16
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by José Boggia, Universidad de la Republica:
Blood pressure control
Hypertension
Office blood pressure
Self-measured blood pressure,
Telemonitoring

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases