NCT07779395

Brief Summary

This study evaluates the effect of an artificial intelligence-supported mobile application, PRESS AI, on pressure injury prevention and nursing care in adult intensive care patients. The application supports nurses in pressure injury risk assessment, wound assessment and staging, and selection of appropriate prevention and care interventions. The study compares the incidence of hospital-acquired pressure injuries before and after the implementation of PRESS AI. During the pre-intervention period, patients receive routine pressure injury prevention and nursing care. During the intervention period, nurses use PRESS AI together with an integrated pressure injury prevention and care algorithm to support clinical assessment and care planning.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Completed
Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 16, 2026

Last Update Submit

August 18, 2026

Conditions

Pressure Injury

Keywords

Pressure InjuryArtificial IntelligenceNursing CareIntensive CareClinical Decision SupportMobile ApplicationPressure Injury Prevention

Outcome Measures

Primary Outcomes (1)

  • Incidence of Hospital-Acquired Pressure Injuries

    The incidence of hospital-acquired pressure injuries will be determined based on newly developed pressure injuries during the intensive care unit stay. Patients will be assessed daily for pressure injury development, including the date of occurrence, anatomical location, and stage. The incidence during the pre-intervention period will be compared with the incidence during the PRESS AI intervention period.

    Daily during each participant's intensive care unit stay; assessed over the 3-month pre-intervention period (March 1-May 31, 2026) and the 3-month intervention period (July 1-September 30, 2026).

Secondary Outcomes (3)

  • Distribution of Pressure Injury Stages

    Daily during each participant's intensive care unit stay; assessed over the 3-month pre-intervention period (March 1-May 31, 2026) and the 3-month intervention period (July 1-September 30, 2026).

  • Anatomical Distribution of Pressure Injuries

    Daily during each participant's intensive care unit stay; assessed over the 3-month pre-intervention period (March 1-May 31, 2026) and the 3-month intervention period (July 1-September 30, 2026).

  • Time to Development of Pressure Injury

    From intensive care unit admission until the first occurrence of a hospital-acquired pressure injury or intensive care unit discharge, whichever occurs first, during the 3-month pre-intervention and 3-month intervention periods.

Study Arms (2)

Routine Nursing Care

NO INTERVENTION

Participants in this arm receive routine pressure injury prevention and nursing care according to standard clinical practice. Pressure injury risk and skin assessments are performed using routine clinical procedures. The PRESS AI mobile application and its integrated pressure injury prevention and care algorithm are not used in this arm.

PRESS AI-Supported Nursing Care

EXPERIMENTAL

Participants in this arm receive pressure injury prevention and nursing care supported by the PRESS AI mobile application and its integrated pressure injury prevention and care algorithm. PRESS AI supports pressure injury risk assessment, skin and wound assessment, artificial intelligence-assisted pressure injury staging, and planning of prevention and care interventions. The final pressure injury staging decision is made by the nurse based on clinical assessment.

Other: PRESS AI-Supported Nursing Care

Interventions

PRESS AI-Supported Nursing CareOTHER

PRESS AI is an artificial intelligence-supported mobile clinical decision support application integrated with a pressure injury prevention and care algorithm. It supports nurses in Braden Scale risk assessment, skin and wound assessment, artificial intelligence-assisted pressure injury staging, and the planning and documentation of individualized pressure injury prevention and care interventions. Artificial intelligence-generated staging recommendations are used to support clinical decision-making and do not replace nurses' clinical judgment. The final pressure injury stage is determined by the nurse based on clinical assessment.

PRESS AI-Supported Nursing Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older.
  • Hospitalized in the Anesthesiology and Reanimation Intensive Care Unit of Ankara University Ibni Sina Research and Application Hospital during the pre-intervention or intervention period.
  • Written informed consent provided by the patient or, when the patient lacks decision-making capacity, by the patient's legally authorized representative.

You may not qualify if:

  • Refusal to participate by the patient or legally authorized representative, or withdrawal of previously provided consent.
  • Missing essential follow-up data required to assess the development of pressure injuries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Ibni Sina Research and Application Hospital

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hilal Tüzer, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gurbet Baduryeri, MSc

CONTACT

+90-555-631-59-34gurbet.bdr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a nonrandomized before-and-after interventional study with two temporally separated groups of participants. Patients enrolled during the pre-intervention period receive routine pressure injury prevention and nursing care. Patients enrolled during the intervention period receive nursing care supported by the PRESS AI mobile application and its integrated pressure injury prevention and care algorithm. The two groups consist of different patients enrolled during separate study periods.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2026

First Posted

August 21, 2026

Study Start

March 1, 2026

Primary Completion

September 30, 2026

Study Completion

September 30, 2026

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data sharing is not planned as part of the current study protocol.

Locations

TU(1)