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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring | Other |
| |
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Rehospitalizations | Rehospitalizations rate during follow-up | 3-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucia M Yanicelli, PhD | Universidad Nacional de Tucumán | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zenón Santillán Health Center Hospital | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31973633 | Derived | Yanicelli LM, Goy CB, Gonzalez VDC, Palacios GN, Martinez EC, Herrera MC. Non-invasive home telemonitoring system for heart failure patients: A randomized clinical trial. J Telemed Telecare. 2021 Oct;27(9):553-561. doi: 10.1177/1357633X19899261. Epub 2020 Jan 23. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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