Heart Failure
Conditions
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.
Interventions
OTHERHome 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.
Sponsors
Universidad Nacional de Tucuman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in self-care | 3-month | 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 | 3-month | Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Rehospitalizations | 3-month | Rehospitalizations rate during follow-up |
Countries
Argentina
Outcome results
None listed