Trial Clínico. Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Universidad Nacional de Tucuman
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in treatment adherence
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Lucía María Yanicelli
PhD in Exact Sciences and Engineering
Universidad Nacional de Tucuman
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.
Outcomes
Primary Outcomes
Changes in treatment adherence
Time Frame: 3-month
Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale
Changes in self-care
Time Frame: 3-month
Changes in self-care at baseline and end line of the follow-up using the European Heart Self-care Behavior Questionnaire
Secondary Outcomes
- Rate of Rehospitalizations(3-month)