- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02155686
Elderly Chronic Diseases Online Biometric Analysis Home Living Technology (e-COBAHLT)
Etude de l'Impact Clinique de la télésurveillance à Domicile Par télémédecine de paramètres biométriques de la Personne âgée Polypathologique
The elderly or people with disabilities want to remain in their homes even when their health condition has been getting worse.
This project aims to demonstrate that home automation and telemonitoring can lead to develop a home safety environment that could help the elderly and individual with disability live independently in their own home.
In this study, the automation sensors containing devices follow up chronic disease clinical factors to monitor their biometrical parameters and detect any abnormal prodromal disease decompensation via telemonitoring and geriatric expertise.
The purpose of this study is:
- to provide clinical evidence of the effectiveness of automation tools and telemonitoring/expertise for the home support for people at risk of loss of autonomy
- to demonstrate the clinical benefit of combining the automation and telemonitoring and geriatric teleexpertise
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Limoges, France, 87042
- Service de Gériatrie - CHU de LImoges
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 or more.
- House equipped with home automation
- Having been hospitalized in the year prior to the inclusion for the following conditions : heart failure, chronic obstructive pulmonary disease (COPD ), diabetes, high blood pressure ( hypertension ) , repetitive falls, chronic renal failure , stroke, neurodegenerative diseases , malnutrition (according to criteria HAS)
- Multiple chronic diseases (at least 2 comorbidities) .
- Having given free and informed consent
Exclusion Criteria:
- Life expectancy less than 12 months
- Enrolled in another clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Biosensors
Participants in this arm are equipped both with home telecare/automation and with biometric sensors
|
Device: Biometric sensors; Home automation; telecare
|
|
Active Comparator: Automation
Participants in this arm are equiepd with home automation only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of unplanned hospitalization for decompensation
Time Frame: at 12 months
|
The effectiveness of home telemonitoring on the cumulative incidence of unplanned hospitalization for decompensation in the elderly
|
at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact on global health
Time Frame: at 12 months
|
|
at 12 months
|
|
Cost/effectivness preventive care
Time Frame: at 12 months
|
Evaluate the cost / effectiveness of the impact of telemonitoring on the preventive care in the elderly
|
at 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Thierry DANTOINE, MD, CHU Limoges
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I13027
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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