Clinical Trials Directory

Trials / Completed

CompletedNCT01495078

Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
178 (actual)
Sponsor
Parc de Salut Mar · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETelemonitoringIs a computer system designed jointly by engineers and clinical personal of Parc Salut Mar) to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring . The system allow weekly follow up throught videoconferences. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses.

Timeline

Start date
2010-12-01
Primary completion
2013-06-01
Completion
2014-12-01
First posted
2011-12-19
Last updated
2016-02-17

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01495078. Inclusion in this directory is not an endorsement.