Home Telemonitoring System for Patients With Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Home Telemonitoring System (HTS)

• Registration Number: NCT04071093
• Lead Sponsor: Universidad Nacional de Tucuman

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-08
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring	Home Telemonitoring System (HTS)	-

Primary Outcome Measures

Name	Time	Method
Changes in treatment adherence	3-month	Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale
Changes in self-care	3-month	Changes in self-care at baseline and end line of the follow-up using the European Heart Self-care Behavior Questionnaire

Secondary Outcome Measures

Name	Time	Method
Rate of Rehospitalizations	3-month	Rehospitalizations rate during follow-up

Trial Locations

Locations (1)

Zenón Santillán Health Center Hospital; 🇦🇷 San Miguel de Tucuman, Tucuman, Argentina