HypertensionERNESTINANCT02730052
Telemonitoring of Uncontrolled Hypertension
A study testing Omron 9200T plus Telemonitoring and Omron 9200T without Telemonitoring in people with Hypertension, run by Universidad de la Republica at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Omron 9200T plus Telemonitoring and Omron 9200T without Telemonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 2016to Dec 2019
- 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 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Argentina4 sites
Center AR-1
Buenos Aires
Center AR-2
Buenos Aires
Center AR-4
Córdoba, Córdoba Province
Center AR-3
Rosario, Santa Fe Province
Uruguay4 sites
Center UY-1
Montevideo, 11600
Center UY-2
Montevideo, 11600
Center UY-3
Montevideo, 11600
Center UY-4
Montevideo, 11600
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Omron 9200T plus Telemonitoring, Omron 9200T without Telemonitoring
- Keywords
- Blood pressure control, Hypertension, Office blood pressure, Self-measured blood pressure,, Telemonitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omron 9200T plus TelemonitoringDevice
Also called Telemonitored Self-BP Measurement
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).
Omron 9200T without TelemonitoringDevice
Also called Conventional 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.
| Study group | Role | What they receive |
|---|---|---|
| Omron 9200T without Telemonitoring | Active comparator | In the control group doctors will receive information on the self-measured blood pressure as recorded at home via a diary card. Receives: Device: Omron 9200T without Telemonitoring |
| Omron 9200T plus Telemonitoring | Experimental | In the intervention group, doctors will receive weekly reports via telemonitoring of self-measured blood pressure. Receives: Device: Omron 9200T plus Telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 years
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: through study completion, an average of 2 years
Assessment of quality of life using the Euro-Quality-of-life questionnaire "EQ-5D-5L"
Measured: 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.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Centers recruited poorly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Republica
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Italiano de Buenos Aires, KU Leuven
- Responsible party
- Principal investigator, José Boggia, Universidad de la Republica
- Investigators
- Jose G Boggia, MD PhD, Principal investigator, Universidad de la Republica - Uruguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730052
- Sponsor's protocol ID
- 11/16
- Acronym
- ERNESTINA
- Status last verified
- Jan 2019
- First submitted
- 28 Feb 2016
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Aparicio LS, Thijs L, Boggia J, Jacobs L, Barochiner J, Odili AN, Alfie J, Asayama K, Cuffaro PE, Nomura K, Ohkubo T, Tsuji I, Stergiou GS, Kikuya M, Imai Y, Waisman GD, Staessen JA; International Database on Home Blood Pressure in Relation to Cardiovascular Outcome (IDHOCO) Investigators. Defining thresholds for home blood pressure monitoring in octogenarians. Hypertension. 2015 Oct;66(4):865-73. doi: 10.1161/HYPERTENSIONAHA.115.05800. Epub 2015 Jul 27.
PubMed 26355122Staessen JA, Kuznetsova T, Stolarz K. Hypertension prevalence and stroke mortality across populations. JAMA. 2003 May 14;289(18):2420-2. doi: 10.1001/jama.289.18.2420. No abstract available.
PubMed 12746368Weinehall L, Ohgren B, Persson M, Stegmayr B, Boman K, Hallmans G, Lindholm LH. High remaining risk in poorly treated hypertension: the 'rule of halves' still exists. J Hypertens. 2002 Oct;20(10):2081-8. doi: 10.1097/00004872-200210000-00029.
PubMed 12359988Burnier M. Medication adherence and persistence as the cornerstone of effective antihypertensive therapy. Am J Hypertens. 2006 Nov;19(11):1190-6. doi: 10.1016/j.amjhyper.2006.04.006.
PubMed 17070434Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.
PubMed 18574054Pickering TG. Home blood pressure monitoring: a new standard method for monitoring hypertension control in treated patients. Nat Clin Pract Cardiovasc Med. 2008 Dec;5(12):762-3. doi: 10.1038/ncpcardio1374. Epub 2008 Oct 14.
PubMed 18852711Parati G, Omboni S, Albini F, Piantoni L, Giuliano A, Revera M, Illyes M, Mancia G; TeleBPCare Study Group. Home blood pressure telemonitoring improves hypertension control in general practice. The TeleBPCare study. J Hypertens. 2009 Jan;27(1):198-203. doi: 10.1097/hjh.0b013e3283163caf.
PubMed 19145785Logan AG, Irvine MJ, McIsaac WJ, Tisler A, Rossos PG, Easty A, Feig DS, Cafazzo JA. Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabetics. Hypertension. 2012 Jul;60(1):51-7. doi: 10.1161/HYPERTENSIONAHA.111.188409. Epub 2012 May 21.
PubMed 22615116McCant F, McKoy G, Grubber J, Olsen MK, Oddone E, Powers B, Bosworth HB. Feasibility of blood pressure telemonitoring in patients with poor blood pressure control. J Telemed Telecare. 2009;15(6):281-5. doi: 10.1258/jtt.2009.090202.
PubMed 19720764Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.
PubMed 19249414Bosworth HB, Olsen MK, McCant F, Harrelson M, Gentry P, Rose C, Goldstein MK, Hoffman BB, Powers B, Oddone EZ. Hypertension Intervention Nurse Telemedicine Study (HINTS): testing a multifactorial tailored behavioral/educational and a medication management intervention for blood pressure control. Am Heart J. 2007 Jun;153(6):918-24. doi: 10.1016/j.ahj.2007.03.004.
PubMed 17540191Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V, Gentry PW, Rose C, Van Houtven C, Wang V, Goldstein MK, Oddone EZ. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med. 2011 Jul 11;171(13):1173-80. doi: 10.1001/archinternmed.2011.276.
PubMed 2174701341st World Medical Assembly. Declaration of Helsinki : recommendations guiding physicians in biomedical research involving human subjects. Bull Pan Am Health Organ 1990; 24: 606-609
Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
PubMed 23817082Staessen JA, Byttebier G, Buntinx F, Celis H, O'Brien ET, Fagard R. Antihypertensive treatment based on conventional or ambulatory blood pressure measurement. A randomized controlled trial. Ambulatory Blood Pressure Monitoring and Treatment of Hypertension Investigators. JAMA. 1997 Oct 1;278(13):1065-72.
PubMed 9315764
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio RioplateNsE Sobre Telemonitoreo en hIpertensos No-controlAdos
- ClinicalTrials.gov ID
- NCT02730052
- Acronym / sponsor ID
- ERNESTINA / 11/16
- Conditions
- Hypertension
- Keywords
- Blood pressure control, Hypertension, Office blood pressure, Self-measured blood pressure,, Telemonitoring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Centers recruited poorly
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad de la RepublicaUniversity, hospital or other
- Collaborators
- Hospital Italiano de Buenos Aires, KU Leuven
- Study start
- Dec 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Apr 2016 (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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omron 9200T without Telemonitoring | Active comparator | Device: Omron 9200T without TelemonitoringIn the control group doctors will receive information on the self-measured blood pressure as recorded at home via a diary card. |
| Omron 9200T plus Telemonitoring | Experimental | Device: Omron 9200T plus TelemonitoringIn the intervention group, doctors will receive weekly reports via telemonitoring of self-measured blood pressure. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- The clinical context is suboptimal for telemonitoring of blood pressure:
- 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.
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 |
|---|---|---|
| Omron 9200T plus TelemonitoringAlso: Telemonitored Self-BP MeasurementTelemonitoring 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). | Device | Omron 9200T plus Telemonitoring |
| Omron 9200T without TelemonitoringAlso: Conventional Self-BP MeasurementSelf-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. | Device | Omron 9200T without Telemonitoring |
Primary outcome
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.
8 secondary outcomes
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
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
Total pill load per day
Time frame: through study completion, an average of 2 years
Number of single-pill combinations
Time frame: 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
Assessment of drug adherence using Morisky questionnaire
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
Time frame: through study completion, an average of 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Background: PubMed 26355122Aparicio LS, Thijs L, Boggia J, Jacobs L, Barochiner J, Odili AN, Alfie J, Asayama K, Cuffaro PE, Nomura K, Ohkubo T, Tsuji I, Stergiou GS, Kikuya M, Imai Y, Waisman GD, Staessen JA; International Database on Home Blood Pressure in Relation to Cardiovascular Outcome (IDHOCO) Investigators. Defining thresholds for home blood pressure monitoring in octogenarians. Hypertension. 2015 Oct;66(4):865-73. doi: 10.1161/HYPERTENSIONAHA.115.05800. Epub 2015 Jul 27.
- Background: PubMed 12746368Staessen JA, Kuznetsova T, Stolarz K. Hypertension prevalence and stroke mortality across populations. JAMA. 2003 May 14;289(18):2420-2. doi: 10.1001/jama.289.18.2420. No abstract available.
- Background: PubMed 12359988Weinehall L, Ohgren B, Persson M, Stegmayr B, Boman K, Hallmans G, Lindholm LH. High remaining risk in poorly treated hypertension: the 'rule of halves' still exists. J Hypertens. 2002 Oct;20(10):2081-8. doi: 10.1097/00004872-200210000-00029.
- Background: PubMed 17070434Burnier M. Medication adherence and persistence as the cornerstone of effective antihypertensive therapy. Am J Hypertens. 2006 Nov;19(11):1190-6. doi: 10.1016/j.amjhyper.2006.04.006.
- Background: PubMed 18574054Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.
- Background: PubMed 18852711Pickering TG. Home blood pressure monitoring: a new standard method for monitoring hypertension control in treated patients. Nat Clin Pract Cardiovasc Med. 2008 Dec;5(12):762-3. doi: 10.1038/ncpcardio1374. Epub 2008 Oct 14.
- Background: PubMed 19145785Parati G, Omboni S, Albini F, Piantoni L, Giuliano A, Revera M, Illyes M, Mancia G; TeleBPCare Study Group. Home blood pressure telemonitoring improves hypertension control in general practice. The TeleBPCare study. J Hypertens. 2009 Jan;27(1):198-203. doi: 10.1097/hjh.0b013e3283163caf.
- Background: PubMed 22615116Logan AG, Irvine MJ, McIsaac WJ, Tisler A, Rossos PG, Easty A, Feig DS, Cafazzo JA. Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabetics. Hypertension. 2012 Jul;60(1):51-7. doi: 10.1161/HYPERTENSIONAHA.111.188409. Epub 2012 May 21.
- Background: PubMed 19720764McCant F, McKoy G, Grubber J, Olsen MK, Oddone E, Powers B, Bosworth HB. Feasibility of blood pressure telemonitoring in patients with poor blood pressure control. J Telemed Telecare. 2009;15(6):281-5. doi: 10.1258/jtt.2009.090202.
- Background: PubMed 19249414Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.
- Background: PubMed 17540191Bosworth HB, Olsen MK, McCant F, Harrelson M, Gentry P, Rose C, Goldstein MK, Hoffman BB, Powers B, Oddone EZ. Hypertension Intervention Nurse Telemedicine Study (HINTS): testing a multifactorial tailored behavioral/educational and a medication management intervention for blood pressure control. Am Heart J. 2007 Jun;153(6):918-24. doi: 10.1016/j.ahj.2007.03.004.
- Background: PubMed 21747013Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V, Gentry PW, Rose C, Van Houtven C, Wang V, Goldstein MK, Oddone EZ. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med. 2011 Jul 11;171(13):1173-80. doi: 10.1001/archinternmed.2011.276.
- Individual participant dataSharing planned: No
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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.
Jose G Boggia, MD PhD principal investigator
Universidad de la Republica - Uruguay
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omron 9200T plus Telemonitoring and Omron 9200T without Telemonitoring in people with Hypertension, run by Universidad de la Republica at 8 sites in 2 countries.
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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Argentina, Uruguay. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time to blood pressure control (time frame: through study completion, an average of 2 years). 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 NCT02730052, which also lists 37 linked publications.
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 1 Feb 2019.