Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613503
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Testing the Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections Incontinence-associated Dermatitis and Caregiving Costs for Incontinence Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The AI Supporter an intelligent excretion management robot leverages artificial intelligence-based vision recognition to autonomously detect and cleanse affected areas followed by drying and changing the diaper thereby reducing caregiver strain and enhancing care quality This study aims to assess the efficacy of the AI Supporter in decreasing the incidence of urinary tract infections and incontinence-associated dermatitis among incontinent patients in addition to exploring its cost-effectiveness
Adopting an experimental two groups and longitudinal design this research utilizes both convenience and random sampling strategies The study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary andor fecal incontinence Participants will intermittently use the AI Supporter over a 14-day period Measurement tools include routine urine analysis
Adopting an experimental two groups and longitudinal design this research utilizes both convenience and random sampling strategies The study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary andor fecal incontinence Participants will intermittently use the AI Supporter over a 14-day period Measurement tools include routine urine analysis
Detailed Description:
Background As Taiwan progresses medically the aging demographic has become a significant challenge leading to an escalation in the disabled population The lack of caregiving manpower represents a critical bottleneck in the provision of long-term care Diaper changing a daily and labor-intensive task for caregivers involves bending motions that pose a risk of musculoskeletal injuries Consequently the imperative development of automated caregiving technologies has emerged The AI Supporter an intelligent excretion management robot leverages artificial intelligence-based vision recognition to autonomously detect and cleanse affected areas followed by drying and changing the diaper thereby reducing caregiver strain and enhancing care quality
Objective This study aims to assess the efficacy of the AI Supporter in decreasing the incidence of urinary tract infections and incontinence-associated dermatitis among incontinent patients in addition to exploring its cost-effectiveness
Methods Adopting an experimental two groups and longitudinal design this research utilizes both convenience and random sampling strategies Scheduled from November 2024 to October 2025 at a residential long-term care facility in Central Taiwan the study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary andor fecal incontinence Participants will intermittently use the AI Supporter over a 14-day period Measurement tools include routine urine analysis incontinence-associated dermatitis rating scales pressure sore assessments skin pH measurements caregiver hours and cost analyses pertaining to diapers and the AI Supporter The principal analytical method employed will be Generalized Estimating Equations GEE with statistical significance defined at p 005
Expected Outcomes The AI Supporter is expected to significantly reduce the occurrence of urinary tract infections and incontinance-associated dermatitis in patients concurrently alleviating caregiver workload and diminishing associated costs
Objective This study aims to assess the efficacy of the AI Supporter in decreasing the incidence of urinary tract infections and incontinence-associated dermatitis among incontinent patients in addition to exploring its cost-effectiveness
Methods Adopting an experimental two groups and longitudinal design this research utilizes both convenience and random sampling strategies Scheduled from November 2024 to October 2025 at a residential long-term care facility in Central Taiwan the study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary andor fecal incontinence Participants will intermittently use the AI Supporter over a 14-day period Measurement tools include routine urine analysis incontinence-associated dermatitis rating scales pressure sore assessments skin pH measurements caregiver hours and cost analyses pertaining to diapers and the AI Supporter The principal analytical method employed will be Generalized Estimating Equations GEE with statistical significance defined at p 005
Expected Outcomes The AI Supporter is expected to significantly reduce the occurrence of urinary tract infections and incontinance-associated dermatitis in patients concurrently alleviating caregiver workload and diminishing associated costs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None