Clinical trial NCT06613503: Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections
Official title: Testing the Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections, Incontinence-associated Dermatitis and Caregiving Costs for Incontinence Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incontinence
Urinary Tract Infection
Incontinence-associated Dermatitis
Cost-effectiveness
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Model Description: In this clinical trial, a parallel design is employed, where participants are randomly assigned to one of two groups: an experimental group and a control group. The experimental group will use the AI-supporter for excretion detection, cleaning, and drying processes, while the control group will use traditional diapers for care. The two groups will not cross over during the trial, meaning participants will remain in their assigned group throughout the study. This design allows for a direct comparison of the intervention's efficacy, with each group receiving a distinct form of care. The primary objective is to assess the effectiveness of the AI-supporter in reducing urinary tract infections and incontinence-associated dermatitis
Primary purpose: HEALTH_SERVICES_RESEARCH

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 and/or 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 and/or 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 \< 0.05.

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.

Eligibility criteria: Inclusion Criteria:

* Participants must have been bedridden for at least 3 months and have urinary and/or fecal incontinence.
* Female participants aged over 20 years old.
* Participants must be capable of wearing the AI-supporter device during the study period.

Exclusion Criteria:

* Participants with severe skin conditions unrelated to incontinence.
* Participants with current urinary tract infections or incontinence-associated dermatitis at the time of enrollment.
* Participants who are unable to provide informed consent or have a legal representative to do so.

Primary outcomes:
measure: white blood cells
timeFrame: 14 days after intervention
measure: Bacterial count
timeFrame: 14 days after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Rom A Master List, Extracted From This Organization'S Records.
Study officials:
affiliation: 011+886+4+22053366#7102
name: Kwo-Chen Lee, ph.D
role: STUDY_DIRECTOR
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