Home Telemonitoring System for Patients With Heart Failure vs Usual Care

Universidad Nacional de Tucuman30 enrolled

Overview

This randomized controlled clinical trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up period of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves quality of life and HF related-knowledge. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Home Telemonitoring SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * were over 18 years with a primary diagnosis of HF, * had been hospitalized at least once time as a consequence of a HF decompensation, * had a Smartphone, * had access to WiFi, * had access to a weight scale and to a blood-pressure monitor Exclusion Criteria: * illiterate patients, * had learning difficulties, * had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.

Locations (1)

Zenón Santillán Health Center Hospital

San Miguel de Tucumán, Tucumán Province, Argentina

Outcomes

Primary Outcomes

Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Time frame: 3-month

Changes in HF related knowledge through the Knowledge of CHF questionnaire

Time frame: 3-month

Data from ClinicalTrials.gov

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