NCT02135458

Brief Summary

Heart failure is the principle cause of hospitalisation for people over 65. the assumption is that a system of home based telemonitoring can reduce the rate of unscheduled hospitalisation or rehospitalisation for heart failure (compared to a care package alone), This randomised controlled pilot study should assess the feasibility in terms of patient inclusion and follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

3 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

April 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

April 9, 2014

Last Update Submit

May 24, 2018

Conditions

Heart Failure

Keywords

Heart failureTelemonitoringtherapeutic educationcare networkhospitalization

Outcome Measures

Primary Outcomes (1)

  • Hospitalization

    Hospitalization at any time during follow-up, emergency, unplanned, inappropriate or early (within one month) rehospitalization or not. The type and length of hospital stay will be recorded.

    one year

Secondary Outcomes (3)

  • Comparison of quality of life

    one year

  • medicoeconomic criteria

    one year

  • efficacy telemonitoring system criteria

    one year

Study Arms (2)

Telemonitoring

EXPERIMENTAL

Home-based patient management using AUTONOM@DOM telemonitoring system to record and transmit heart rate, blood pressure and weight; along side conventional care (patient therapeutic education or personalised care program)

Other: TelemonitoringOther: Conventional care

Conventional care

ACTIVE COMPARATOR

Conventional care including patient therapeutic education or personalised care program

Other: Conventional care

Interventions

TelemonitoringOTHER
Telemonitoring
Conventional careOTHER
Also known as: Patient therapeutic education: ETICS HPGM, or, Personalized care program: RESIC 38
Conventional careTelemonitoring

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 years or more
  • Covered by French social security system or equivalent
  • Written informed consent signed by patient
  • Heart failure diagnosed by a cardiologue
  • NYHA stage II, III or IV
  • Able to be followed-up for 1 year
  • Attend general healthcare education sessions

You may not qualify if:

  • Freedom restricted by judicial order
  • Under legal protection
  • Require peritoneal dialysis or hemofiltration
  • Participation refused by patient, primary care physician or cardiologist
  • Present a severe comorbidity with poor short-term prognosis
  • Present asymptomatic heart failure NYHA stage I
  • Programmed surgical intervention: valve prosthesis or revascularization
  • Impossibility to follow a program of patient education
  • Residing in medicalized care facility for persons without autonomy
  • Residing outside the recruitment zones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Private Geriatric Hospital Magnolias

Ballainvilliers, 91160, France

Location

Hospital Group Mutualiste

Grenoble, 38028, France

Location

University Hospital of Grenoble

Grenoble, 38043, France

Location

Related Publications (6)

  • Maggioni AP, Greene SJ, Fonarow GC, Bohm M, Zannad F, Solomon SD, Lewis EF, Baschiera F, Hua TA, Gimpelewicz CR, Lesogor A, Gheorghiade M; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial. Eur Heart J. 2013 Oct;34(40):3117-27. doi: 10.1093/eurheartj/eht342. Epub 2013 Sep 2.

    PMID: 23999456BACKGROUND

  • Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954.

    PMID: 23478743BACKGROUND

  • Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

    PMID: 23186936BACKGROUND

  • Jourdain P, Juilliere Y; Steering and Working Group Committee Members of the French Task Force on Therapeutic Education in Heart Failure. Therapeutic education in patients with chronic heart failure: proposal for a multiprofessional structured programme, by a French Task Force under the auspices of the French Society of Cardiology. Arch Cardiovasc Dis. 2011 Mar;104(3):189-201. doi: 10.1016/j.acvd.2010.12.003. No abstract available.

    PMID: 21634217BACKGROUND

  • Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.

    PMID: 21127322BACKGROUND

  • Jondeau G, Neuder Y, Eicher JC, Jourdain P, Fauveau E, Galinier M, Jegou A, Bauer F, Trochu JN, Bouzamondo A, Tanguy ML, Lechat P; B-CONVINCED Investigators. B-CONVINCED: Beta-blocker CONtinuation Vs. INterruption in patients with Congestive heart failure hospitalizED for a decompensation episode. Eur Heart J. 2009 Sep;30(18):2186-92. doi: 10.1093/eurheartj/ehp323. Epub 2009 Aug 30.

    PMID: 19717851BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Muriel SALVAT, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Yannick NEUDER, University Hospital, Grenoble

Study Record Dates

First Submitted

April 9, 2014

First Posted

May 12, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

June 1, 2017

Last Updated

May 25, 2018

Record last verified: 2018-05

Locations

FR(3)