Home Telemonitoring System for Patients With Heart Failure vs Usual Care

NCT ID: NCT04437849

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-05-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telemonitoring

Group Type: EXPERIMENTAL

Home Telemonitoring System

Intervention Type: DEVICE

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.

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Nacional de Tucuman

OTHER

Sponsor Role: lead

Responsible Party

Lucía María Yanicelli

Principal Investigator PhD in Exact Sciences and Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zenón Santillán Health Center Hospital

San Miguel de Tucumán, Tucumán Province, Argentina

Countries

Argentina

Other Identifiers

0094

Identifier Type: -

Identifier Source: org_study_id