Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections

NCT06613503 | Recruiting

• 1 other identifier: CMUH113-REC3-109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence; Urinary Tract Infection; Incontinence-associated Dermatitis; Cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• white blood cells

  urine analysis

  14 days after intervention

• Bacterial count

  urine analysis

  14 days after intervention

Study Arms (2)

AI-supporter

EXPERIMENTAL

Participants will use the AI-supporter for excretion detection, cleaning, and drying processes.

Device: AI-supporter

Traditional Diapers

NO INTERVENTION

Participants will use theTraditional Diapers for excretion detection, cleaning, and drying processes

Interventions

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

Also known as: tradiational diapear

AI-supporter

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

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

Taichung, Taiwan

RECRUITING

Related Publications (16)

• Borchert K, Bliss DZ, Savik K, Radosevich DM. The incontinence-associated dermatitis and its severity instrument: development and validation. J Wound Ostomy Continence Nurs. 2010 Sep-Oct;37(5):527-35. doi: 10.1097/WON.0b013e3181edac3e.

  PMID: 20736860 BACKGROUND

• Buckingham KW, Berg RW. Etiologic factors in diaper dermatitis: the role of feces. Pediatr Dermatol. 1986 Feb;3(2):107-12. doi: 10.1111/j.1525-1470.1986.tb00499.x.

  PMID: 3513143 BACKGROUND

• Fader M, Clarke-O'Neill S, Cook D, Dean G, Brooks R, Cottenden A, Malone-Lee J. Management of night-time urinary incontinence in residential settings for older people: an investigation into the effects of different pad changing regimes on skin health. J Clin Nurs. 2003 May;12(3):374-86. doi: 10.1046/j.1365-2702.2003.00731.x.

  PMID: 12709112 BACKGROUND

• Ferreira M, Abbade L, Bocchi SCM, Miot HA, Boas PV, Guimaraes HQCP. Incontinence-associated dermatitis in elderly patients: prevalence and risk factors. Rev Bras Enferm. 2020;73 Suppl 3:e20180475. doi: 10.1590/0034-7167-2018-0475. Epub 2020 Jul 13. English, Portuguese.

  PMID: 32696899 BACKGROUND

• Francis K, Pang SM, Cohen B, Salter H, Homel P. Disposable Versus Reusable Absorbent Underpads for Prevention of Hospital-Acquired Incontinence-Associated Dermatitis and Pressure Injuries. J Wound Ostomy Continence Nurs. 2017 Jul/Aug;44(4):374-379. doi: 10.1097/WON.0000000000000337.

  PMID: 28549048 BACKGROUND

• Gray M. Optimal management of incontinence-associated dermatitis in the elderly. Am J Clin Dermatol. 2010;11(3):201-10. doi: 10.2165/11311010-000000000-00000.

  PMID: 20131923 BACKGROUND

• Hachem JP, Crumrine D, Fluhr J, Brown BE, Feingold KR, Elias PM. pH directly regulates epidermal permeability barrier homeostasis, and stratum corneum integrity/cohesion. J Invest Dermatol. 2003 Aug;121(2):345-53. doi: 10.1046/j.1523-1747.2003.12365.x.

  PMID: 12880427 BACKGROUND

• Hahnel E, Blume-Peytavi U, Trojahn C, Kottner J. Associations between skin barrier characteristics, skin conditions and health of aged nursing home residents: a multi-center prevalence and correlational study. BMC Geriatr. 2017 Nov 13;17(1):263. doi: 10.1186/s12877-017-0655-5.

  PMID: 29132305 BACKGROUND

• Kayser SA, Phipps L, VanGilder CA, Lachenbruch C. Examining Prevalence and Risk Factors of Incontinence-Associated Dermatitis Using the International Pressure Ulcer Prevalence Survey. J Wound Ostomy Continence Nurs. 2019 Jul/Aug;46(4):285-290. doi: 10.1097/WON.0000000000000548.

  PMID: 31276451 BACKGROUND

• Minematsu T, Yamamoto Y, Nagase T, Naito A, Takehara K, Iizaka S, Komagata K, Huang L, Nakagami G, Akase T, Oe M, Yoshimura K, Ishizuka T, Sugama J, Sanada H. Aging enhances maceration-induced ultrastructural alteration of the epidermis and impairment of skin barrier function. J Dermatol Sci. 2011 Jun;62(3):160-8. doi: 10.1016/j.jdermsci.2011.03.005. Epub 2011 Mar 23.

  PMID: 21498052 BACKGROUND

• Mugita Y, Koudounas S, Nakagami G, Weller C, Sanada H. Assessing absorbent products' effectiveness for the prevention and management of incontinence-associated dermatitis caused by urinary, faecal or double adult incontinence: A systematic review. J Tissue Viability. 2021 Nov;30(4):599-607. doi: 10.1016/j.jtv.2021.07.002. Epub 2021 Jul 13.

  PMID: 34376333 BACKGROUND

• Musa MK, Saga S, Blekken LE, Harris R, Goodman C, Norton C. The Prevalence, Incidence, and Correlates of Fecal Incontinence Among Older People Residing in Care Homes: A Systematic Review. J Am Med Dir Assoc. 2019 Aug;20(8):956-962.e8. doi: 10.1016/j.jamda.2019.03.033. Epub 2019 May 23.

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  PMID: 15382413 BACKGROUND

• Shin YS, Kim HJ, Moon NK, Ahn YH, Kim KO. The effects of uncoated paper on skin moisture and transepidermal water loss in bedridden patients. J Clin Nurs. 2012 Sep;21(17-18):2469-76. doi: 10.1111/j.1365-2702.2012.04160.x.

  PMID: 22889444 BACKGROUND

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  PMID: 22642800 BACKGROUND

• Yeomans A, Davitt M, Peters CA, Pastuszek C, Cobb S. Efficacy of chlorhexidine gluconate use in the prevention of perirectal infections in patients with acute leukemia. Oncol Nurs Forum. 1991 Sep-Oct;18(7):1207-13.

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Related Links

• Incontinence-associated dermatitis: moving prevention forward
• The Impact of an Absorbent Underpad on the Prevention and/or Improvement of Incontinence Associated Dermatitis in Skilled Nursing Facility (SNF) Residents.
• IAD made easy.

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kwo-Chen Lee, ph.D

  011+886+4+22053366#7102

  STUDY DIRECTOR

Central Study Contacts

Kwo-Chen Lee, ph.D

CONTACT

886422053366; rubylee@mail.cmu.edu.tw

Jing-ya Fu

CONTACT

886422053366

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 26, 2024
• Study Start: July 22, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)