Remote Monitoring of Chronic Heart Failure in Veneto Region

NCT01513993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2015-10-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

Conditions

  • Congestive Heart Failure

Interventions

PROCEDURE

Telemonitoring for patients with Congestive Heart Failure

Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device and digital weight scale for clinical parameters measuring and a gateway device for data transmission. The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG and body weight, with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the reference clinician in case of worsening of symptoms.

Sponsors & Collaborators

  • European Commission

    collaborator OTHER
  • Azienda Unità Locale Socio Sanitaria n.9 Treviso

    collaborator OTHER
  • Azienda ULSS 7 Conegliano

    collaborator OTHER
  • Azienda ULSS 16 Padova

    collaborator OTHER
  • Azienda ULSS di Verona e Provincia

    collaborator OTHER
  • Azienda ULSS 12 Veneziana

    collaborator OTHER
  • Azienda Unità Socio Sanitaria di Dolo Mirano

    collaborator OTHER
  • Azienda Ospedaliera di Padova

    collaborator OTHER
  • Azienda Ospedaliera Universitaria Integrata Verona

    collaborator OTHER
  • Regione Veneto

    lead OTHER

Principal Investigators

  • Zoran Olivari, DM · Azienda Unità Locale Socio Sanitaria n.9 Treviso

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513993 on ClinicalTrials.gov