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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

January 17, 2012
January 21, 2014
October 2011
May 2014   (final data collection date for primary outcome measure)
Combined end point of all cause mortality and number of hospitalisations for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01513993 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Remote Monitoring of Chronic Heart Failure in Veneto Region
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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.

  • No Intervention: Control group
    Treatment as usual
  • Experimental: Telemonitoring for patients with Congestive Heart Failure
    Intervention: Procedure: Telemonitoring for patients with Congestive Heart Failure

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
315
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: Zoran Olivari, MD 0422322767 segcardiotv@ulss.tv.it
Contact: Gianluigi Scannapieco, MD 0422323232 gscannapieco@ulss.tv.it
Italy
 
NCT01513993
G. A. 250487-Veneto WP8Cl7
Yes
Regione Veneto
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
Principal Investigator: Zoran Olivari, DM Azienda Unità Locale Socio Sanitaria n.9 Treviso
Regione Veneto
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP