ERNESTINA: Telemonitoring of Uncontrolled Hypertension

Sponsor

Universidad de la Republica (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02730052

Collaborator

Hospital Italiano de Buenos Aires (Other), KU Leuven (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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:

Test the feasibility of telemonitoring of blood pressure in uncontrolled hypertensive patients.
Investigate whether telemonitoring enabled self-measurement of blood pressure leads to faster blood pressure control than self-measurement without telemonitoring.
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	N/A

Detailed Description

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.

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

0 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 :

Dec 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time to blood pressure control [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

The proportion of patients reaching blood pressure control on self-measurement at home and office measurement [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.
The proportion of patients reaching and maintaining blood pressure control on self-measurement and office measurement at the late follow-up visit [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.
Total pill load per day [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.
Number of single-pill combinations [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.
Adverse events, recorded by a self-administered questionnaire [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.
Assessment of drug adherence using Morisky questionnaire [through study completion, an average of 2 years]
We will use Morisky questionaire to asses adherence to anti-hypertensive treatment
Assessment of quality of life using the Euro-Quality-of-life questionnaire "EQ-5D-5L" [through study completion, an average of 2 years]
Health care costs from randomization to last follow-up [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Women and men are eligible. Women of reproductive age should apply effective contraception.
Age ranges from 20 years (inclusive) to 80 years.
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.
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).
Patient should provide written informed consent.

Exclusion Criteria:

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.

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.
Patients should not participate in any other trial of an investigational drug or device.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center AR-4	Ciudad de Cordoba	Cordoba	Argentina
2	Center AR-3	Rosario	Santa-Fe	Argentina
3	Center AR-1	Buenos Aires		Argentina
4	Center AR-2	Buenos Aires		Argentina
5	Center UY-1	Montevideo		Uruguay	11600
6	Center UY-2	Montevideo		Uruguay	11600
7	Center UY-3	Montevideo		Uruguay	11600
8	Center UY-4	Montevideo		Uruguay	11600