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NCT Number: NCT06613503

Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rom A Master List, Extracted From This Organization'S Records.

Taichung, Taiwan

Location status: Recruiting

Location contact

Kwo chen Lee

CONTACT

[email protected]

886922351328

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-supporter

Device

rticipants in the experimental group will use the AI-supporter, an intelligent excretion management robot. This device utilizes AI-driven visual recognition technology to automatically detect urine and feces, followed by a cleaning and drying process. When the AI-supporter detects excretion, it activates an automated sequence that washes, dries, and sanitizes the perineal area without requiring the caregiver to remove the diaper. The AI-supporter also records relevant data, such as the time, frequency, and weight of excretion, for further analysis. This intervention is designed to reduce the incidence of urinary tract infections (UTIs) and incontinence-associated dermatitis (IAD), as well as lessen the workload for caregivers

Other names: tradiational diapear

Primary outcomes

  1. white blood cells

    Time frame: 14 days after intervention

    urine analysis

  2. Bacterial count

    Time frame: 14 days after intervention

    urine analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Jing-ya Fu

CONTACT

886422053366 ext. 7102

Kwo-Chen Lee, ph.D

CONTACT

[email protected]

886422053366 ext. 7102

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

Testing the Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections, Incontinence-associated Dermatitis and Caregiving Costs for Incontinence Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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