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Home Telemonitoring System for Patients With Heart Failure

NCT04071093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-28

No results posted yet for this study

Summary

This randomized controlled trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves self-care and treatment adherence. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.

Conditions

Interventions

OTHER

Home Telemonitoring System (HTS)

The HTS consists of an App that daily collects measurements of weight, blood pressure, heart rate and symptoms (checklist of symptoms questions). The HTS processes the data and generates and sends an alert to the physicians if a risk situation occurs (measurements are outside of normal ranges). The App has also an educational functionality that allows learning about lifestyle, self-care and healthy habits for HF patients. For this purpose, the application: a) has a section that answers frequent questions, b) has a question and answer game about HF, and c) sends educational messages to the patients every day.

Sponsors & Collaborators

  • Universidad Nacional de Tucuman

    lead OTHER

Principal Investigators

  • Lucia M Yanicelli, PhD · Universidad Nacional de Tucumán

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • Argentina

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071093 on ClinicalTrials.gov