Clinical trial NCT01495078: Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
Official title: Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: telemonitoring
heart failure
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of the study is to determine the effect of automated daily selfreported symptom and weight, blood pressure and heart rate monitoring and clinical follow-up videoconference comigrate with clinical follow-up face in specialized hospital unit in reducing heart failure non-fatal events.

Detailed description: The insuﬁcie 'ncia Cardı´aca Optimitzacio ´ Remota (iCOR; Heart Failure Remote Optimization) trial was a singlecentre, randomized, open-label study designed to evaluate the eﬃcacy of the addition of telemedicine (telemonitorization and teleintervention using videoconference) to an existing specialized, multidisciplinary, nurse-based, hospitalprimary care integrated HF programme for high-risk patients with CHF. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published.2 In this study we aimed to compare the strategy of providing nurse-based structured follow-up to high-risk CHF patients through planned contacts between health care providers and patients and/or caregivers in the basis of face-to-face on-site encounters (usual care in our HF programme) or provide the planned care using telemedicine with the combination of remote daily monitoring of signs and symptoms of HF (telemonitoring) and delivery of structured nursebased follow-up health care using videoconference (teleintervention). The main hypothesis of this study was that adding telemedicine to an existing HF programme would be associated with a reduction in the number of non-fatal HF events in high-risk patients with CHF. As a secondary hypothesis we assumed that adding telemedicine would translate into a reduction in health care resource utilization and subsequently in health care costs.

Eligibility criteria: Inclusion Criteria:

* Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study.

Exclusion Criteria:

* Less than 18 years
* Long-term nursing home residence, irreversible medical conditions, Folstein Mini-mental State Exam score less than 20.
* No access to 3G line, currently scheduled for cardiac transplant, left ventricular assist device or valvular surgery,coronary intervention within 90 days of randomisation.

Primary outcomes:
measure: Non fatal events
timeFrame: Six months after inclusion of the patient.
Secondary outcomes:
measure: Morbid mortality
timeFrame: From telemonitoring (baseline) until six months later
measure: Hospital readmission
timeFrame: From telemonitoring (baseline) until six months later
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar
Study officials:
affiliation: HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE
name: JOSEP COMIN COLET, MD
role: PRINCIPAL_INVESTIGATOR
References: