Clinical Trials Logo

Filter by:
  • Withdrawn  
  • Page [1]
NCT ID: NCT02730052 Withdrawn - Hypertension Clinical Trials

Telemonitoring of Uncontrolled Hypertension

ERNESTINA
Start date: December 2016
Phase: N/A
Study type: Interventional

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.