Telemonitoring of Uncontrolled Hypertension

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.

Conditions

• Hypertension

Interventions

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).

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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• Universidad de la Republica

  lead OTHER

Principal Investigators

• Jose G Boggia, MD PhD · Universidad de la Republica - Uruguay

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2019-06-30

Completion

2019-12-31

Countries

• Argentina
• Uruguay

Study Locations