Home Telemonitoring System for Patients With Heart Failure vs Usual Care
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Home Telemonitoring System
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
Experimental
No Intervention
Arm Label
Telemonitoring
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Changes in HF related knowledge through the Knowledge of CHF questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT04437849
First Posted
June 12, 2020
Last Updated
June 16, 2020
Sponsor
Universidad Nacional de Tucuman
1. Study Identification
Unique Protocol Identification Number
NCT04437849
Brief Title
Home Telemonitoring System for Patients With Heart Failure vs Usual Care
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
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 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 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.
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
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Home Telemonitoring System
Intervention Description
Home Telemonitoring System (HTS) 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 quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time Frame
3-month
Title
Changes in HF related knowledge through the Knowledge of CHF questionnaire
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.
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
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Home Telemonitoring System for Patients With Heart Failure vs Usual Care
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