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Remote Monitoring of Chronic Heart Failure in Veneto Region

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01513993
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : October 28, 2015
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

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Procedure: Telemonitoring for patients with Congestive Heart Failure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure
Study Start Date : October 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Combined end point of all cause mortality and number of hospitalisations for heart failure [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Cardiovascular and all-cause mortality [ Time Frame: 12 months ]
  2. Health-Related Quality of Life [ Time Frame: 12 months ]
    Health-Related Quality of Life is assessed by the SF-36 questionnaire

  3. Number of hospitalisations (including rehospitalisations) for all causes and for heart failure [ Time Frame: 12 months ]
  4. Total number of days in hospital [ Time Frame: 12 months ]
  5. Number of specialist visits [ Time Frame: 12 months ]
  6. Number of visits at emergency department for heart failure [ Time Frame: 12 months ]
  7. Anxiety and depression status [ Time Frame: 12 months ]
    Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513993


Locations
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Italy
Ospedale Immacolata Concezione - Cardiology Department
Piove di Sacco, Padova, Italy, 35028
Presidio ospedaliero di Conegliano - Department of Cardiology
Conegliano, Treviso, Italy, 31015
Ospedale di Mirano - Cardiology Department
Mirano, Venezia, Italy, 30035
Ospedale San Fracastoro - Cardiology Department
San Bonifacio, Verona, Italy, 37047
Azienda Ospedaliera di Padova - Cardiology Department
Padova, Italy, 35128
Ospedale Ca'Foncello - Pulmonology Department
Treviso, Italy, 31100
Ospedale SS Giovanni e Paolo - Cardiology Department
Venezia, Italy, 30122
Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department
Verona, Italy, 37124
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
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Principal Investigator: Zoran Olivari, DM Azienda Unità Locale Socio Sanitaria n.9 Treviso
More Information
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Additional Information:

Publications:

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Responsible Party: Regione Veneto
ClinicalTrials.gov Identifier: NCT01513993    
Other Study ID Numbers: G. A. 250487-Veneto WP8Cl7
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: January 2012
Keywords provided by Regione Veneto:
CHF
Telemonitoring
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases