Heart FailureAUTONOM@DOMNCT02135458
Evaluation of the AUTONOM@DOM Telemonitoring System for People With Heart Failure
A study testing Telemonitoring and Conventional care in people with Heart Failure, run by University Hospital, Grenoble at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telemonitoring and Conventional care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2014to Jun 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Private Geriatric Hospital Magnolias
Ballainvilliers, 91160
Hospital Group Mutualiste
Grenoble, 38028
University Hospital of Grenoble
Grenoble, 38043
About this study
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.
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.
Read the detailed 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.
- Conditions
- Heart Failure
- Being tested
- Telemonitoring, Conventional care
- Keywords
- Heart failure, Telemonitoring, therapeutic education, care network, hospitalization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringOther
Conventional careOther
Also called Patient therapeutic education: ETICS HPGM, or, Personalized care program: RESIC 38
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Telemonitoring; Other: Conventional care |
| Conventional care | Active comparator | Conventional care including patient therapeutic education or personalised care program Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (3)
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
Measured: one year
medicoeconomic criteria
health expenditures and quality of life first. If follow-up turns out feasible, cost-effectiveness and cost-utility ratios
Measured: one year
efficacy telemonitoring system criteria
number and type of telemonitoring alerts and their clinical relevance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Medico-economic evaluation unit , University Hospital, Grenoble
- Responsible party
- Principal investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Muriel SALVAT, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135458
- Sponsor's protocol ID
- DCIC 13 61
- Acronym
- AUTONOM@DOM
- Status last verified
- May 2018
- First submitted
- 9 Apr 2014
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23999456Gheorghiade 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.
PubMed 23478743Logeart 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.
PubMed 23186936Jourdain 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.
PubMed 21634217Roncalli 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.
PubMed 21127322Jondeau 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.
PubMed 19717851
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02135458
- Acronym / sponsor ID
- AUTONOM@DOM / DCIC 13 61
- Conditions
- Heart Failure
- Keywords
- Heart failure, Telemonitoring, therapeutic education, care network, hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Medico-economic evaluation unit , University Hospital, Grenoble
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Other: Telemonitoring, Other: Conventional careHome-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) |
| Conventional care | Active comparator | Other: Conventional careConventional care including patient therapeutic education or personalised care program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoring | Other | Telemonitoring |
| Conventional careAlso: Patient therapeutic education: ETICS HPGM, or, Personalized care program: RESIC 38 | Other | Conventional care, Telemonitoring |
Primary outcome
Hospitalization
Time frame: one year
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.
3 secondary outcomes
Comparison of quality of life
Time frame: one year
medicoeconomic criteria
Time frame: one year
efficacy telemonitoring system criteria
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Background: PubMed 23999456Maggioni 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.
- Background: PubMed 23478743Gheorghiade 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.
- Background: PubMed 23186936Logeart 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.
- Background: PubMed 21634217Jourdain 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.
- Background: PubMed 21127322Roncalli 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.
- Background: PubMed 19717851Jondeau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muriel SALVAT, MD principal investigator
University Hospital, Grenoble
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring and Conventional care in people with Heart Failure, run by University Hospital, Grenoble at 3 sites in France.
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 7 inclusion and 10 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 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Hospitalization (time frame: one year). 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 NCT02135458, 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 25 May 2018.