- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008472
Telemedicine - Evaluation of the Impact of a Telemedicine Device (DTM) on the Prevention of Emergency Department Visits and Hospitalizations of Nursing Home Residents Aged Polypathological (GERONTACCESS)
For several decades, there is an aging population, particularly in industrialized countries. This lengthening of the duration of life is accompanied by an increase in the number of chronically ill patients. On an estimate of 15 million patients in France today, the figure reported for 2020 would be 20 million patients. Chronic diseases are responsible for functional decompensation and admission responsible autonomy breaks in nursing homes (Accommodation Establishment of People Dependent Elderly).
An estimated 700,000 the number of people currently living in retirement homes in France. These residents are mostly dependent and multiple pathologies requiring regular general and specialist medical monitoring . Medical concern demographic outlook and the need for access to quality care across the country leads to the development of telemedicine.
The need for telemedicine is not the same throughout the territory. It is less, or different, in highly urbanized areas where the density of health professionals is high, then it can be a new response to the needs of rural, isolated or landlocked. Telemedicine promotes the development of the concept of graduated care sector, especially in the management of patients with chronic diseases.
Telemedicine in rural nursing homes and can be a tool for assessing, monitoring and coordination to avoid decompensation of chronic conditions and rehospitalization.
This organization can afford to break the isolation of general practitioners and EHPAD coordinators physicians in rural areas and provide access to several specialties.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Resident in one of 9 nursing homes participating in the project
- Resident polypathologique has at least two comorbidities
- Having made no request to change place of residence at the time of the inclusion visit
- Having given free consent, informed writing and signed by himself and / or his legal representative
Exclusion Criteria:
- Unaffiliated resident or non-receiving of social security
- severe pathology (ies) involving life-threatening in the short term
- Resident whose return home, transfer to another nursing home or to a long term care unit is programmed
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: Telemedecine
Patients benefiting from telemedicine
|
Initiation of tele-medical consultation with the resident, a caregiver for the nursing home, the referring physician and geriatrician téléexpert.
After a overall geriatric assessment in nursing homes by UPSAV the first teleconsultation is organized within 10 days.
Subsequent visits are scheduled every 3 months for 12 months.
Spontaneous visits can be requested at the initiative of the referring physician.
|
|
No Intervention: Control
routine care without telemedecine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of telemedicine on prevention in old and polypathological patients
Time Frame: After 12 months
|
Proportion of patients with emergency admission or unscheduled hospitalization in medical or surgical service over 12 months.
|
After 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medico-economic impact
Time Frame: After 12 months
|
cost effectiveness of the telemedicine device
|
After 12 months
|
|
Impact on recurring hospitalizations
Time Frame: After 12 months
|
Number of readmissions
|
After 12 months
|
|
Impact on overall health
Time Frame: After 12 months
|
Number of emergency admissions Number of readmissions Number of days of hospitalization Number of medical consultations o
|
After 12 months
|
|
Impact on the quality of life ( EQ5D questionnary)
Time Frame: After 12 months
|
The EQ-5D (Europen Qyuality of llive) five dimension scale) questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Higher values represent a worse outcome. The scale ranges from 5 to 15. |
After 12 months
|
|
Impact on mortality
Time Frame: After 12 months
|
Proportion of patients who died at 12 months
|
After 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Achille TCHALLA, Professor, University Hospital, Limoges
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 (Actual)
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
- I14036 - GERONTACCESS
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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