Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02135458
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
Medico-economic evaluation unit , University Hospital, Grenoble
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Telemonitoring Other: Conventional care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Telemonitoring
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: Telemonitoring
Other: Conventional care
Other Names:
  • Patient therapeutic education: ETICS HPGM
  • or
  • Personalized care program: RESIC 38

Active Comparator: Conventional care
Conventional care including patient therapeutic education or personalised care program
Other: Conventional care
Other Names:
  • Patient therapeutic education: ETICS HPGM
  • or
  • Personalized care program: RESIC 38




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Comparison of quality of life [ Time Frame: one year ]
    loss of autonomy and loss of function, quality of life, depression and anxiety, malnutrition, mortality and clinical stage of the disease

  2. medicoeconomic criteria [ Time Frame: one year ]
    health expenditures and quality of life first. If follow-up turns out feasible, cost-effectiveness and cost-utility ratios

  3. efficacy telemonitoring system criteria [ Time Frame: one year ]
    number and type of telemonitoring alerts and their clinical relevance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135458


Locations
Layout table for location information
France
Private Geriatric Hospital Magnolias
Ballainvilliers, France, 91160
Hospital Group Mutualiste
Grenoble, France, 38028
University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Medico-economic evaluation unit , University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Muriel SALVAT, MD University Hospital, Grenoble
Publications:

Layout table for additonal information
Responsible Party: AdministrateurCIC, Dr Yannick NEUDER, University Hospital, Grenoble, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02135458    
Other Study ID Numbers: DCIC 13 61
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Keywords provided by AdministrateurCIC, University Hospital, Grenoble:
Heart failure
Telemonitoring
therapeutic education
care network
hospitalization
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases