NCT01513993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 28, 2015

Status Verified

January 1, 2012

Enrollment Period

2.6 years

First QC Date

January 17, 2012

Last Update Submit

October 27, 2015

Conditions

Congestive Heart Failure

Keywords

CHFTelemonitoring

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (7)

  • Cardiovascular and all-cause mortality

    12 months

  • Health-Related Quality of Life

    12 months

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

    12 months

  • Total number of days in hospital

    12 months

  • Number of specialist visits

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Treatment as usual

Telemonitoring for patients with Congestive Heart Failure

EXPERIMENTAL
Procedure: Telemonitoring for patients with Congestive Heart Failure

Interventions

Telemonitoring for patients with Congestive Heart FailurePROCEDURE

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.

Telemonitoring for patients with Congestive Heart Failure

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Azienda Ospedaliera di Padova - Cardiology Department

Padua, Padova, 35128, Italy

Location

Ospedale Immacolata Concezione - Cardiology Department

Piove di Sacco, Padova, 35028, Italy

Location

Presidio ospedaliero di Conegliano - Department of Cardiology

Conegliano, Treviso, 31015, Italy

Location

Ospedale Ca'Foncello - Pulmonology Department

Treviso, Treviso, 31100, Italy

Location

Ospedale di Mirano - Cardiology Department

Mirano, Venezia, 30035, Italy

Location

Ospedale SS Giovanni e Paolo - Cardiology Department

Venezia, Venezia, 30122, Italy

Location

Ospedale San Fracastoro - Cardiology Department

San Bonifacio, Verona, 37047, Italy

Location

Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department

Verona, Verona, 37124, Italy

Location

Related Publications (6)

  • 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.

    PMID: 19687005BACKGROUND

  • 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.

    PMID: 17426062BACKGROUND

  • 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.

    PMID: 21733889BACKGROUND

  • 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.

    PMID: 21080835BACKGROUND

  • 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.

    PMID: 19850208BACKGROUND

  • 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.

    PMID: 20687083BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Zoran Olivari, DM

    Azienda Unità Locale Socio Sanitaria n.9 Treviso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 20, 2012

Study Start

October 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 28, 2015

Record last verified: 2012-01

Locations

IT(8)