Home Telemonitoring System for Patients With Heart Failure vs Usual Care

Trial Clínico: Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04437849

Enrollment

Registered

2020-06-18

Start date

2018-08-01

Completion date

2019-05-01

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

Interventions

DEVICEHome Telemonitoring System

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)	3-month
Changes in HF related knowledge through the Knowledge of CHF questionnaire	3-month

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026