Clinical Investigation Evaluating the Use of NETSmart Solution , Incorporated to NETSoins Software, in the Care and Support of Elderly People Living in Nursing Homes

NCT ID: NCT07027358

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-03
• Study Completion Date: 2025-04-01

Brief Summary

NETSmart software is designed to help doctors, nurses and care assistants adapt the care of elderly people living in nursing homes to the following risks:

• pressure injuries
• undernutrition
• interactions between different drugs
• falls. The software analyzes the information in your medical records, alerts your medical team to any points of vigilance, and suggests appropriate recommendations.

The study comprises 2 distinct phases:

• An initial 4-month phase, during which the medical staff will simply assess whether the NETSmart software's recommendations are relevant, without changing their current practice, i.e. they will continue to care for you as usual;
• A second 6-month phase, during which your caregivers will follow the software's recommendations if they feel they are relevant, and potentially adapt your care.

Conditions

Pressure Injury; Fall Prevention; Undernutrition; Drug Interaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NETSmart

Use of NETSmart software by healthcare professionals for these patients

Group Type: EXPERIMENTAL

NETSmart software

Intervention Type: DEVICE

Use of NETSmart software by healthcare professionals

Interventions

NETSmart software

Use of NETSmart software by healthcare professionals

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female, at least 70 years old
• Permanent resident at an investigation site for at least 6 months.
• Considered an at-risk patient, i.e. meeting at least one of the following criteria :
• Braden score < 16
• At risk of pressure ulcer according to the investigator's judgment
• At risk of undernutrition as judged by the investigator
• Undergoing at least 6 drug treatments
• At risk of falls as judged by the investigator
• Affiliated with the French social security system
• Having given informed, dated and signed consent to participate in the investigation

Exclusion Criteria

• Patient with a life expectancy of less than 2 months as judged by the investigator
• Patient who is participating or has participated in another investigation or study involving the use of a medical device or drug within 30 days prior to inclusion

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RCTs

INDUSTRY

Sponsor Role: collaborator

Teranga Software

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maison de Famille Bourgogne

Étang-sur-Arroux, , France

Countries

France

Other Identifiers

2024-A00812-45

Identifier Type: -

Identifier Source: org_study_id