Home Telemonitoring System for Patients With Heart Failure vs Usual Care

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437849
• Other study ID #: 0094
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: June 2020
• Source: Universidad Nacional de Tucuman
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Home 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.

Locations

Country	Name	City	State
Argentina	Zenón Santillán Health Center Hospital	San Miguel de Tucuman	Tucuman

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Tucuman

Country where clinical trial is conducted

Argentina, 

Outcome

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