- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04679181
Acceptability Assessment of an "Organization of Care Integrating Artificial Intelligence and a Solution of Telemedicine" on Care of the Nursing Home Residents Located in a Medical Desert: Pilot Study INTEL@MED-POC (Intel@Med-Poc)
Study Overview
Detailed Description
The ageing of the population comes along with the problematic of chronic pathologies and dependence, with sometimes serious consequences resulting in an admission in Nursing Home. While the low require a medical doctor in each Nursing Home, one third of the Nursing Home does not have. Some Nursing Homes can be in a tricky situation with no medical doctor coordinator and the difficulty of access to a medical doctor who covered a wide territory. In this context, the emergence of Artificial Intelligence coupled with Telemedicine is a new opportunity to find solution in healthcare organization and to develop advanced geriatric medical practice in medical desert territory. The goal of this study is to quantify and characterize the acceptability of Artificial Intelligence and Telemedicine in Nursing Home located in medical desert for patients, nurses, and medical doctor.
All the patients were examined by a nurse. The symptoms filled by the nurse in the Artificial Intelligence/Telemedicine device are sent and then analyzed by a distant medical doctor to purpose a care. The nurse also solicited the attending medical doctor as usual care.
The recommendations of the both medical doctors could be (i) Vital emergency, (ii) non-vital emergency necessitate medication or hospitalization, and (iii) non-emergency with medical appointment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Achille TCHALLA, MD
- Phone Number: +33555058894
- Email: achille.tchalla@chu-limoges.fr
Study Locations
-
-
-
Auzances, France, 23700
- Not yet recruiting
- EHPAD Le Bois Joli
-
Contact:
- Emmanuelle Gaillard, Nurse
- Phone Number: 05.55.67.73.30
-
Chambon-sur-Voueize, France, 23170
- Not yet recruiting
- EHPAD Le Chant des Rivières
-
Contact:
- Marina Blondonnet, Nurse
- Phone Number: 05.55.82.11.02
-
La Roche Chalais, France, 24490
- Not yet recruiting
- EHPAD La Porte d'Aquitaine
-
Contact:
- Remi Rambonona, Nurse
- Phone Number: 05.53.91.41.30
-
Merlines, France, 19340
- Recruiting
- Ehpad Le Chavanon
-
Contact:
- Sandrine Malgat, Nurse
- Phone Number: 07.55.64.50.73
- Email: telemedecine@pompidou-merlines.fr
-
Peyrelevade, France, 19290
- Recruiting
- EHPAD Ernest Coulaud
-
Contact:
- Raphaël Bessaudou, Nurse
- Phone Number: 05.55.94.72.85
- Email: rbessaudou@mutualitelimousine.fr
-
Saint Privat, France, 19220
- Recruiting
- EHPAD J et M Colaud
-
Contact:
- Aurélie Malarange, Nurse
- Phone Number: 05.55.28.26.54
- Email: direction.ehpadstprivat@orange.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient older than 65 years old.
- Patient living in Nursing Home located in medical desert.
- Patient presenting symptoms involved medical doctor call.
- Patient or legal representative having signed consent form
- Patient covered by social security
Exclusion Criteria:
- End of life patient.
- Chronic aphasic patient.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Active arm
use of telemedicine
|
telemedical consultation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability for nurse to use Artificial Intelligence / Telemedecine device analyzed by distant medical doctor
Time Frame: 13 months
|
Proportion of the Artificial Intelligence / Telemedecine utilization by the nurse vs medical doctor as usual care
|
13 months
|
Number of non-programmed hospitalization for both distant medical doctor and usual care recommendations
Time Frame: 13 months
|
Comparison of non programmed hospitalization in both distant medical doctor analysis and medical doctor as usual care
|
13 months
|
delay to obtain the medical expertise
Time Frame: 13 months
|
Comparison of time to obtain the medical expertise for distant medical doctor and usual care recommandations
|
13 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sensitivity and specificity of diagnostic
Time Frame: 13 months
|
Calculation of sensitivity and specificity of diagnostic for acute disease and emergency for both distant medical doctor and usual care recommendations
|
13 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Other Study ID Numbers
- 87RI18-0018/Intel@Med-Poc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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