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Completed

NCT Number: NCT04071093

Home Telemonitoring System for Patients With Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zenón Santillán Health Center Hospital

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home Telemonitoring System (HTS)

Other

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.

Primary outcomes

  1. Changes in self-care

    Time frame: 3-month

    Changes in self-care at baseline and end line of the follow-up using the European Heart Self-care Behavior Questionnaire

  2. Changes in treatment adherence

    Time frame: 3-month

    Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale

Secondary outcomes

  1. Rate of Rehospitalizations

    Time frame: 3-month

    Rehospitalizations rate during follow-up

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Tucuman

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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