Evaluation of the AUTONOM@DOM Telemonitoring System for People With Heart Failure (AUTONOM@DOM)
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|ClinicalTrials.gov Identifier: NCT02135458|
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : May 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Other: Telemonitoring Other: Conventional care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||84 participants|
|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|
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
Active Comparator: Conventional care
Conventional care including patient therapeutic education or personalised care program
Other: Conventional care
- 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.
- 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
- 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
- efficacy telemonitoring system criteria [ Time Frame: one year ]number and type of telemonitoring alerts and their clinical relevance
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
|Private Geriatric Hospital Magnolias|
|Ballainvilliers, France, 91160|
|Hospital Group Mutualiste|
|Grenoble, France, 38028|
|University Hospital of Grenoble|
|Grenoble, France, 38043|
|Principal Investigator:||Muriel SALVAT, MD||University Hospital, Grenoble|