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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Telemonitoring
* Other: Conventional care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring<br>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<br> <br> Other: Conventional care<br> <br> * Other names: Personalized care program: RESIC 38;|
| Active Comparator: Conventional care<br>Conventional care including patient therapeutic education or personalised care program | Other: Conventional care<br> <br> * Other names: Personalized care program: RESIC 38;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| medicoeconomic criteria | 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 | number and type of telemonitoring alerts and their clinical relevance | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Telemonitoring, therapeutic education, care network, hospitalization