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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2019
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Biosensors
Device: Biometric sensors; Home automation; telecare
Home automation


Locations

Country Name City State
France Service de Gériatrie - CHU de LImoges Limoges

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

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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