Back to resultsElderly Chronic Diseases Online Biometric Analysis Home Living Technology (e-COBAHLT)
Primary Purpose
The Elderly
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biosensors
Home automation
Sponsored by
About this trial
This is an interventional prevention trial for The Elderly focused on measuring Elderly, Prevention, Multiple chronic disease, Telemonitoring, Geriatric teleexpertise, Home heath care, Medico-economics
Eligibility Criteria
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
Sites / Locations
- Service de Gériatrie - CHU de LImoges
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biosensors
Automation
Arm Description
Participants in this arm are equipped both with home telecare/automation and with biometric sensors
Participants in this arm are equiepd with home automation only
Outcomes
Primary Outcome Measures
Number of unplanned hospitalization for decompensation
The effectiveness of home telemonitoring on the cumulative incidence of unplanned hospitalization for decompensation in the elderly
Secondary Outcome Measures
Impact on global health
Number of visits to the emergency
Number of readmissions
Number of days of hospitalization
Number of visits to the doctor
Cost/effectivness preventive care
Evaluate the cost / effectiveness of the impact of telemonitoring on the preventive care in the elderly
Full Information
NCT ID
NCT02155686
First Posted
May 24, 2014
Last Updated
January 9, 2019
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT02155686
Brief Title
Elderly Chronic Diseases Online Biometric Analysis Home Living Technology
Acronym
e-COBAHLT
Official Title
Etude de l'Impact Clinique de la télésurveillance à Domicile Par télémédecine de paramètres biométriques de la Personne âgée Polypathologique
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 27, 2014 (Actual)
Primary Completion Date
September 9, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Elderly
Keywords
Elderly, Prevention, Multiple chronic disease, Telemonitoring, Geriatric teleexpertise, Home heath care, Medico-economics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
536 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biosensors
Arm Type
Experimental
Arm Description
Participants in this arm are equipped both with home telecare/automation and with biometric sensors
Arm Title
Automation
Arm Type
Active Comparator
Arm Description
Participants in this arm are equiepd with home automation only
Intervention Type
Device
Intervention Name(s)
Biosensors
Intervention Description
Device: Biometric sensors; Home automation; telecare
Intervention Type
Device
Intervention Name(s)
Home automation
Primary Outcome Measure Information:
Title
Number of unplanned hospitalization for decompensation
Description
The effectiveness of home telemonitoring on the cumulative incidence of unplanned hospitalization for decompensation in the elderly
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Impact on global health
Description
Number of visits to the emergency
Number of readmissions
Number of days of hospitalization
Number of visits to the doctor
Time Frame
at 12 months
Title
Cost/effectivness preventive care
Description
Evaluate the cost / effectiveness of the impact of telemonitoring on the preventive care in the elderly
Time Frame
at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry DANTOINE, MD
Organizational Affiliation
CHU Limoges
Official's Role
Study Chair
Facility Information:
Facility Name
Service de Gériatrie - CHU de LImoges
City
Limoges
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
Learn more about this trial
Elderly Chronic Diseases Online Biometric Analysis Home Living Technology
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