Evaluation of the AUTONOM@DOM Telemonitoring System for People With Heart Failure

Heart Failure Clinical Trial

— AUTONOM@DOM  

Official title:

Clinical and Medico-economic Assessment of Conventional Care Plus the "Autonom@Dom" Telemonitoring System Versus a Conventional Care Package Alone, for People With Heart Failure in Several French Structures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135458
• Other study ID #: DCIC 13 61
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: June 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Chronic diseases such as heart failure are a major burden for healthcare systems They are punctuated by exacerbations, often markers of poor prognosis, and are associated with expensive unscheduled hospitalizations. After initial diagnosis, despite the development of both drug and physical therapies, the rate of re-hospitalization for heart failure remains high with 50% or more of patients readmitted within 6 months.

Recommendations for the treatment of heart failure patients are extremely precise and justify close collaboration between local community services and the hospital. However there is often considerable divergence between recommended care and the reality, due in particular to the difficulty in monitoring ambulatory patients. For example, the dose titration of beta-blockers or ACE inhibitors need to be monitored, and dosages of diuretics need to be adapted to avoid side effects which affect the quality of life of patients and limit medication adherence etc. The establishment of 'ambulatory' care networks (including multidisciplinary health professionnals of city and hospital and therapeutic patient education) such as that in Isère County in France has demonstrated its effectiveness.

However, more advanced tools for patient monitoring still need to be assessed, particularly 'home monitoring', because there is not yet consensus as to the role tele-monitoring should play in the context of heart failure, and to date recommendations are vague. Assess the clinical and medico-economic benefit of an innovative patient monitoring strategy 'AUTONOM @ DOM' is needed.

The primary aim of this study is then to assess a system of home based telemonitoring .The main outcome is unscheduled hospitalisation for heart failure. secondary aims were to assess the efficacy of this system, quality of life and medico-economic benefit.

This pilot study is realised in the Isère and Essonne counties of France. Patients diagnosed with heart failure will be randomized to one of the following groups:

• conventional care including at least a patient education program (ETICS program in Essone county and RESIC38 network in Isere county);

• conventional care, plus home telemonitoring including a recording of the heart rate, blood pressure and weight, remotely transmitted to the cardiologist by an approved validated system that includes an alert monitoring feature.

The study will last one year starting in April 2014.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2017
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Telemonitoring

• Conventional care

Locations

Country	Name	City	State
France	Private Geriatric Hospital Magnolias	Ballainvilliers
France	Hospital Group Mutualiste	Grenoble
France	University Hospital of Grenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Medico-economic evaluation unit , University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (6)

Gheorghiade M, Böhm 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. Erratum in: JAMA. 2013 Apr 10;309(14):1461. — View Citation

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. — View Citation

Jourdain P, Juillière 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. — View Citation

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. — View Citation

Maggioni AP, Greene SJ, Fonarow GC, Böhm 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of quality of life	loss of autonomy and loss of function, quality of life, depression and anxiety, malnutrition, mortality and clinical stage of the disease	one year
Secondary	medicoeconomic criteria	health expenditures and quality of life first. If follow-up turns out feasible, cost-effectiveness and cost-utility ratios	one year
Secondary	efficacy telemonitoring system criteria	number and type of telemonitoring alerts and their clinical relevance	one year