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Completed

NCT Number: NCT01513993

Remote Monitoring of Chronic Heart Failure in Veneto Region

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera di Padova - Cardiology Department, Padova, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring for patients with Congestive Heart Failure

Procedure

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.

Primary outcomes

  1. Combined end point of all cause mortality and number of hospitalisations for heart failure

    Time frame: 12 months

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Regione Veneto

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2012
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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