Development and Effectiveness Verification of an AI Application for Pressure Injury Nursing Based on Clinical Judgment Model

NCT07132320 | Completed DMC

• 1 other identifier: 4-2024-0677
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to develop a pressure ulcer nursing AI mobile application based on a clinical judgment model and verify its effectiveness among clinical nurses. The study consists of algorithm development, application design, implementation, and a comparative evaluation of nurses using the AI app versus a control group not given the application. Outcomes include clinical judgment, knowledge in pressure ulcer nursing, educational satisfaction, and pressure ulcer incidence. The investigators expect the AI-driven intervention to improve practical nursing skills, reduce pressure ulcer occurrence, and contribute to patient-centered care in hospital settings.

Conditions

Pressure Ulcer; Nursing Education

Keywords

Pressure Ulcer; clinical judgment; artificial intelligence; Nursing; Education

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Judgment Competence Score

  The difference in clinical judgment score measured by the modified Lasater Clinical Judgment Rubric specific for pressure ulcer management.

  Baseline, Post-intervention (approximately 2 weeks)

Secondary Outcomes (3)

• Change in Pressure Ulcer Nursing Knowledge Score

  Baseline, Post-intervention (approximately 2 weeks)

• Change in Educational Satisfaction Score

  Baseline, Post-intervention (approximately 2 weeks)

• Pressure Ulcer Incidence

  Baseline, Post-intervention (approximately 2 weeks)

Study Arms (2)

Experimental Group

EXPERIMENTAL

clinical nurses receive training and guidance via an AI application designed for pressure ulcer nursing based on a clinical judgment model.

Biological: Pressure Ulcer Nursing AI Application Training

Control Group

ACTIVE COMPARATOR

Clinical nurses receive conventional pressure ulcer nursing education not involving the developed AI application.

Biological: Traditional Pressure Ulcer Nursing Education

Interventions

Pressure Ulcer Nursing AI Application Training BIOLOGICAL

Clinical nurses receive training and guidance via an AI application designed for pressure ulcer nursing based on a clinical judgment model.

Experimental Group

Traditional Pressure Ulcer Nursing Education BIOLOGICAL

Clinical nurses receive conventional pressure ulcer nursing education not involving the developed AI application.

Control Group

Eligibility Criteria

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

You may qualify if:

• Registered nurse working at a tertiary hospital, directly engaged in patient care
• ≥3 years experience (algorithm development phase) or ≥1 year experience (evaluation phase)
• Written informed consent

You may not qualify if:

• Communication difficulties for interviews (analysis phase)
• Unable to understand education for AI application (evaluation phase)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Wound Ostomy Team

Seoul, South Korea

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 20, 2025
• Study Start: November 15, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)