Remote Monitoring of Chronic Heart Failure in Veneto Region

October 27, 2015 updated by: Regione Veneto

RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is designed to evaluate the impact of telemonitoring on the management of CHF compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to reduct the combined end point of all cause mortality and re-hospitalizations, as well as the other kinds of access to hospital facilities (bed-days, specialistic and ER visits). The trial will examine whether the CHF patients improve their health-related quality of life and reduct the anxiety about health conditions, thanks to the telemonitoring. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professional perception towards the service.

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova - Cardiology Department
      • Treviso, Italy, 31100
        • Ospedale Ca'Foncello - Pulmonology Department
      • Venezia, Italy, 30122
        • Ospedale SS Giovanni e Paolo - Cardiology Department
      • Verona, Italy, 37124
        • Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department
    • Padova
      • Piove di Sacco, Padova, Italy, 35028
        • Ospedale Immacolata Concezione - Cardiology Department
    • Treviso
      • Conegliano, Treviso, Italy, 31015
        • Presidio ospedaliero di Conegliano - Department of Cardiology
    • Venezia
      • Mirano, Venezia, Italy, 30035
        • Ospedale di Mirano - Cardiology Department
    • Verona
      • San Bonifacio, Verona, Italy, 37047
        • Ospedale San Fracastoro - Cardiology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 65 years.
  • Discharge from hospital after acute heart failure in the previous 3 months and EF < 40% or EF > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization

Exclusion Criteria:

  • Comorbidities prevalent on CHF with life expectation < 12 months.
  • Impossibility or inability to use the equipment and help at home not available.
  • Myocardial infarction or percutaneous coronary intervention in the last 3 months or scheduled.
  • Coronary artery bypass, valve substitution or correction in the last 6 months.
  • Being on waiting list for heart transplantation.
  • Being enrolled in other trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Treatment as usual
Experimental: Telemonitoring for patients with Congestive Heart Failure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined end point of all cause mortality and number of hospitalisations for heart failure
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular and all-cause mortality
Time Frame: 12 months
12 months
Health-Related Quality of Life
Time Frame: 12 months
Health-Related Quality of Life is assessed by the SF-36 questionnaire
12 months
Number of hospitalisations (including rehospitalisations) for all causes and for heart failure
Time Frame: 12 months
12 months
Total number of days in hospital
Time Frame: 12 months
12 months
Number of specialist visits
Time Frame: 12 months
12 months
Number of visits at emergency department for heart failure
Time Frame: 12 months
12 months
Anxiety and depression status
Time Frame: 12 months
Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regione Veneto

Collaborators

Azienda Ospedaliera Universitaria Integrata Verona
Azienda Ospedaliera di Padova
European Commission
Azienda ULSS 16 Padova
Azienda Unità Locale Socio Sanitaria n.9 Treviso
Azienda ULSS di Verona e Provincia
Azienda ULSS 7 Conegliano
Azienda ULSS 12 Veneziana
Azienda Unità Socio Sanitaria di Dolo Mirano

Investigators

  • Principal Investigator: Zoran Olivari, DM, Azienda Unità Locale Socio Sanitaria n.9 Treviso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G. A. 250487-Veneto WP8Cl7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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