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Home Telemonitoring System for Patients With Heart Failure vs Usual Care

U

Universidad Nacional de Tucuman

Status

Completed

Conditions

Heart Failure

Treatments

Device: Home Telemonitoring System

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Telemonitoring
Experimental group
Treatment:
Device: Home Telemonitoring System
Usual Care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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