The Elderly Clinical Trial
— e-COBAHLTOfficial title:
Etude de l'Impact Clinique de la télésurveillance à Domicile Par télémédecine de paramètres biométriques de la Personne âgée Polypathologique
NCT number | NCT02155686 |
Other study ID # | I13027 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 27, 2014 |
Est. completion date | January 1, 2019 |
Verified date | January 2019 |
Source | University Hospital, Limoges |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 536 |
Est. completion date | January 1, 2019 |
Est. primary completion date | September 9, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Service de Gériatrie - CHU de LImoges | Limoges |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of unplanned hospitalization for decompensation | The effectiveness of home telemonitoring on the cumulative incidence of unplanned hospitalization for decompensation in the elderly | at 12 months | |
Secondary | Impact on global health | Number of visits to the emergency Number of readmissions Number of days of hospitalization Number of visits to the doctor |
at 12 months | |
Secondary | Cost/effectivness preventive care | Evaluate the cost / effectiveness of the impact of telemonitoring on the preventive care in the elderly | at 12 months |
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