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Congestive Heart FailureNCT01513993

Remote Monitoring of Chronic Heart Failure in Veneto Region

A study testing Telemonitoring for patients with Congestive Heart Failure in people with Congestive Heart Failure, run by Regione Veneto at 8 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
Telemonitoring for patients with Congestive Heart Failure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
8 sitesItaly
Study dates
Oct 2011to May 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Italy8 sites

  • Presidio ospedaliero di Conegliano - Department of Cardiology

    Conegliano, Treviso, 31015

  • Ospedale di Mirano - Cardiology Department

    Mirano, Venezia, 30035

  • Azienda Ospedaliera di Padova - Cardiology Department

    Padova, Padova, 35128

  • Ospedale Immacolata Concezione - Cardiology Department

    Piove di Sacco, Padova, 35028

  • Ospedale San Fracastoro - Cardiology Department

    San Bonifacio, Verona, 37047

  • Ospedale Ca'Foncello - Pulmonology Department

    Treviso, Treviso, 31100

  • Ospedale SS Giovanni e Paolo - Cardiology Department

    Venezia, Venezia, 30122

  • Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department

    Verona, Verona, 37124

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Telemonitoring for patients with Congestive Heart Failure
Keywords
CHF, Telemonitoring
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemonitoring for patients with Congestive Heart FailureProcedure or surgery

    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.

Study groups in NCT01513993
Study groupRoleWhat they receive
Control groupNo interventionTreatment as usual
Telemonitoring for patients with Congestive Heart FailureExperimentalNot described
Receives: Procedure: Telemonitoring for patients with Congestive Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

Secondary outcomes (7)

  1. Cardiovascular and all-cause mortality

    Measured: 12 months

  2. Health-Related Quality of Life

    Health-Related Quality of Life is assessed by the SF-36 questionnaire

    Measured: 12 months

  3. Number of hospitalisations (including rehospitalisations) for all causes and for heart failure

    Measured: 12 months

  4. Total number of days in hospital

    Measured: 12 months

  5. Number of specialist visits

    Measured: 12 months

  6. Number of visits at emergency department for heart failure

    Measured: 12 months

  7. Anxiety and depression status

    Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2012 (estimated)
  2. Study startOct 2011
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513993
Sponsor's protocol ID
G. A. 250487-Veneto WP8Cl7
Status last verified
Jan 2012
First submitted
17 Jan 2012
Last updated
28 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Scherr D, Kastner P, Kollmann A, Hallas A, Auer J, Krappinger H, Schuchlenz H, Stark G, Grander W, Jakl G, Schreier G, Fruhwald FM; MOBITEL Investigators. Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. J Med Internet Res. 2009 Aug 17;11(3):e34. doi: 10.2196/jmir.1252.

    PubMed 19687005

  • Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. Epub 2007 Apr 10.

    PubMed 17426062

  • 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. doi: 10.1093/eurjhf/hfr039. Epub 2011 Jul 6.

    PubMed 21733889

  • 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. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.

    PubMed 21080835

  • Klersy C, De Silvestri A, Gabutti G, Regoli F, Auricchio A. A meta-analysis of remote monitoring of heart failure patients. J Am Coll Cardiol. 2009 Oct 27;54(18):1683-94. doi: 10.1016/j.jacc.2009.08.017.

    PubMed 19850208

  • Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.

    PubMed 20687083

Questions about this trial

What is this clinical trial studying?

A study testing Telemonitoring for patients with Congestive Heart Failure in people with Congestive Heart Failure, run by Regione Veneto at 8 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined end point of all cause mortality and number of hospitalisations for heart failure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01513993, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.

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