Back to resultsHome Telemonitoring System for Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Home Telemonitoring System (HTS)
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- Zenón Santillán Health Center Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Telemonitoring
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
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
Changes in treatment adherence
Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale
Secondary Outcome Measures
Rate of Rehospitalizations
Rehospitalizations rate during follow-up
Full Information
NCT ID
NCT04071093
First Posted
August 22, 2019
Last Updated
August 26, 2019
Sponsor
Universidad Nacional de Tucuman
1. Study Identification
Unique Protocol Identification Number
NCT04071093
Brief Title
Home Telemonitoring System for Patients With Heart Failure
Official Title
Trial Clínico. Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional de Tucuman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemonitoring
Arm Type
Other
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Home Telemonitoring System (HTS)
Intervention Description
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 Outcome Measure Information:
Title
Changes in self-care
Description
Changes in self-care at baseline and end line of the follow-up using the European Heart Self-care Behavior Questionnaire
Time Frame
3-month
Title
Changes in treatment adherence
Description
Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale
Time Frame
3-month
Secondary Outcome Measure Information:
Title
Rate of Rehospitalizations
Description
Rehospitalizations rate during follow-up
Time Frame
3-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia M Yanicelli, PhD
Organizational Affiliation
Universidad Nacional de Tucumán
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zenón Santillán Health Center Hospital
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
12. IPD Sharing Statement
Citations:
PubMed Identifier
31973633
Citation
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.
Results Reference
derived
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Home Telemonitoring System for Patients With Heart Failure
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