Home Telemonitoring System for Patients With Heart Failure

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Home Telemonitoring System (HTS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Telemonitoring<br> | Other: Home Telemonitoring System (HTS)<br>* 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.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Rehospitalizations | Rehospitalizations rate during follow-up | 3-month |