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Home Telemonitoring System for Patients With Heart Failure vs Usual Care

Not Applicable
Completed
Conditions
Heart Failure
Interventions
Device: Home Telemonitoring System
Registration Number
NCT04437849
Lead Sponsor
Universidad Nacional de Tucuman
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.

Detailed Description

Not available

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
GroupInterventionDescription
TelemonitoringHome Telemonitoring System-
Primary Outcome Measures
NameTimeMethod
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 questionnaire3-month
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Zenón Santillán Health Center Hospital

🇦🇷

San Miguel de Tucuman, Tucuman, Argentina

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