NCT05547295

Brief Summary

The study focuses on the impact of a digital MEDIASCREEN tool on the knowledge, technical know-how and behavioural skills in terms of pressure sores of patients. In addition, the cognitive impact of this type of tool will also be studied in our study population (self-esteem and feeling of personal effectiveness). The objective is to compare the impact of a digital MEDIASCREEN information tool with information tool compared to the usual paper-based prevention materials on knowledge of the risk of hospital-acquired pressure sores.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 7, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 27, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

July 7, 2022

Last Update Submit

July 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the change on the knowledge of the risk of hospital-acquired pressure sores with a digital MEDIASCREEN information tool in comparison to the usual paper-based prevention materials

    The comparison will be done with Skin-Management Needs Assessment Checklist score (SMNac). Minimum value =0, Maximum value = 100; higher score better outcome.

    Change from baseline knowledge at 1 month

Secondary Outcomes (9)

  • Evaluate patient satisfaction with the information delivered by the MEDIASCREEN digital tool

    At 1 month

  • Assess the cognitive impact of the prevention information delivered by MEDIASCREEN tool, on self-esteem.

    At the beginning and at 1 month

  • Assess the cognitive impact of the prevention information delivered by MEDIASCREEN tool, on sense of self-efficacy.

    At the beginning and at 1 month

  • Evaluate the psychological impact of information delivered from the tools

    At 1 month

  • Evaluate the occurrence of pressure sores during hospitalization

    At the beginning and at 1 month

  • +4 more secondary outcomes

Study Arms (2)

Paper Information

OTHER

Patient will have classic paper information for prevention of pressure sores

Other: Paper prevention

Numeric information from MEDIASCREEN

EXPERIMENTAL

Patient will have information for prevention of pressure sores throught the digital tool MEDIASCREEN

Other: Numeric prevention

Interventions

Numeric information for prevention of pressure sores thgrough digital tool MEDIASCREEN

Numeric information from MEDIASCREEN

Information for prevention of pressure sores in classic way with paper

Paper Information

Eligibility Criteria

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

You may qualify if:

  • Patient in complete hospitalization in Physical Medicine and Rehabilitation
  • Patient affiliated to a social security system
  • Patient presenting a low to high risk of pressure ulcer inferior or equal to or equal to 16 on the Norton scale
  • Patient having signed his consent

You may not qualify if:

  • Difficulty understanding and is unable to give free and informed consent
  • Pregnant women
  • Person deprived of liberty by a judicial or administrative administrative decision
  • Major under legal protection by a judicial or administrative decision.
  • Person in an emergency situation unable to give their informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle Saint-Hélier

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Aurélie Duruflé

    Pôle Saint Hélier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

September 21, 2022

Study Start

October 27, 2022

Primary Completion

January 16, 2025

Study Completion

January 16, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Locations