Remote Monitoring of Chronic Heart Failure in Veneto Region

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Regione Veneto.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
European Commission
Azienda Unità Locale Socio Sanitaria n.9 Treviso
Azienda ULSS 7 Conegliano
Azienda ULSS 16 Padova
Azienda ULSS di Verona e Provincia
Azienda ULSS 12 Veneziana
Azienda Unità Socio Sanitaria di Dolo Mirano
Azienda Ospedaliera di Padova
Azienda Ospedaliera Universitaria Integrata Verona
Information provided by (Responsible Party):
Regione Veneto
ClinicalTrials.gov Identifier:
NCT01513993
First received: January 17, 2012
Last updated: January 21, 2014
Last verified: January 2012
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Procedure: Telemonitoring for patients with Congestive Heart Failure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Regione Veneto:

Primary Outcome Measures:
  • Combined end point of all cause mortality and number of hospitalisations for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular and all-cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Health-Related Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health-Related Quality of Life is assessed by the SF-36 questionnaire

  • Number of hospitalisations (including rehospitalisations) for all causes and for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Total number of days in hospital [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of specialist visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of visits at emergency department for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Anxiety and depression status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS)


Estimated Enrollment: 315
Study Start Date: October 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513993

Contacts
Contact: Zoran Olivari, MD 0422322767 segcardiotv@ulss.tv.it
Contact: Gianluigi Scannapieco, MD 0422323232 gscannapieco@ulss.tv.it

Locations
Italy
Ospedale Immacolata Concezione - Cardiology Department Recruiting
Piove di Sacco, Padova, Italy, 35028
Principal Investigator: Domenico Marchese, MD         
Presidio ospedaliero di Conegliano - Department of Cardiology Recruiting
Conegliano, Treviso, Italy, 31015
Principal Investigator: Carlo Marcon, MD         
Ospedale di Mirano - Cardiology Department Recruiting
Mirano, Venezia, Italy, 30035
Principal Investigator: Emanuele Bertaglia, MD         
Ospedale San Fracastoro - Cardiology Department Recruiting
San Bonifacio, Verona, Italy, 37047
Principal Investigator: Maurizio Anselmi, MD         
Principal Investigator: Claudio Bellamoli, MD         
Azienda Ospedaliera di Padova - Cardiology Department Recruiting
Padova, Italy, 35128
Principal Investigator: Sabino Iliceto, MD         
Ospedale Ca'Foncello - Pulmonology Department Recruiting
Treviso, Italy, 31100
Principal Investigator: Zoran Olivari, MD         
Ospedale SS Giovanni e Paolo - Cardiology Department Recruiting
Venezia, Italy, 30122
Principal Investigator: Michelangelo Penzo, MD         
Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department Recruiting
Verona, Italy, 37124
Principal Investigator: Vincenzo Di Francesco, MD         
Sponsors and Collaborators
Regione Veneto
European Commission
Azienda Unità Locale Socio Sanitaria n.9 Treviso
Azienda ULSS 7 Conegliano
Azienda ULSS 16 Padova
Azienda ULSS di Verona e Provincia
Azienda ULSS 12 Veneziana
Azienda Unità Socio Sanitaria di Dolo Mirano
Azienda Ospedaliera di Padova
Azienda Ospedaliera Universitaria Integrata Verona
Investigators
Principal Investigator: Zoran Olivari, DM Azienda Unità Locale Socio Sanitaria n.9 Treviso
  More Information

Additional Information:
Publications:
Inglis SC, Clark RA, McAlister FA, Stewart S, Cleland JG. Which components of heart failure programmes are effective? A systematic review and meta-analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: Abridged Cochrane Review. Eur J Heart Fail. 2011 Sep;13(9):1028-40. Epub 2011 Jul 6.
Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. Epub 2010 Nov 16.

Responsible Party: Regione Veneto
ClinicalTrials.gov Identifier: NCT01513993     History of Changes
Other Study ID Numbers: G. A. 250487-Veneto WP8Cl7
Study First Received: January 17, 2012
Last Updated: January 21, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Regione Veneto:
CHF
Telemonitoring

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014