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

May 24, 2018 updated by: AdministrateurCIC, University Hospital, Grenoble

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ballainvilliers, France, 91160
        • Private Geriatric Hospital Magnolias
      • Grenoble, France, 38043
        • University hospital of Grenoble
      • Grenoble, France, 38028
        • Hospital Group Mutualiste

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year
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
one year
efficacy telemonitoring system criteria
Time Frame: one year
number and type of telemonitoring alerts and their clinical relevance
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Medico-economic evaluation unit , University Hospital, Grenoble

Investigators

  • Principal Investigator: Muriel SALVAT, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 13 61

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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