Evaluation of the Impact of a Digital Tool MEDIASCREEN of Preventive Information for Patients on the Knowledge of the Risk of Pressure Sores Acquired During a Hospitalization (EDUCESCARRES)

July 29, 2025 updated by: Pôle Saint Hélier

Evaluation of the Impact of a Digital Tool MEDIASCREEN of Preventive Information for Patients on the Knowledge of the Risk of Pressure Sores Acquired During a Hospitalization, a Randomized Controlled Pilot Interventional Study in Single Blind

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bretagne
      • Rennes, Bretagne, France, 35000
        • Pôle Saint-Hélier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Paper Information
Patient will have classic paper information for prevention of pressure sores
Information for prevention of pressure sores in classic way with paper
Experimental: Numeric information from MEDIASCREEN
Patient will have information for prevention of pressure sores throught the digital tool MEDIASCREEN
Numeric information for prevention of pressure sores thgrough digital tool MEDIASCREEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Change from baseline knowledge at 1 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate patient satisfaction with the information delivered by the MEDIASCREEN digital tool
Time Frame: At 1 month

Measured by Visual Analogic scale from 0 to 100. Zero is represented : "Not at all satisfied" and 100 : "Completely satisfied".

Higher scores better outcome.

At 1 month
Assess the cognitive impact of the prevention information delivered by MEDIASCREEN tool, on self-esteem.
Time Frame: At the beginning and at 1 month
Measured of self-esteem with Rosenberg scale. Score range : 10-40. High scores indicate high 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.
Time Frame: At the beginning and at 1 month
Measured of self-efficacy with scale to evaluate the feeling of personal effectiveness (MSES) Score range: 16-80. High scores indicate high feeling of personal effectiveness.
At the beginning and at 1 month
Evaluate the psychological impact of information delivered from the tools
Time Frame: At 1 month

Measured by Visual Analogic scale from 0 to 100. Zero is represented : "No knowledge" and 100 : "Perfectly mastered subject".

Higher scores better outcome.

At 1 month
Evaluate the occurrence of pressure sores during hospitalization
Time Frame: At the beginning and at 1 month
Count of the apparition number of pressure sores.
At the beginning and at 1 month
Evaluate the acquisition of knowledge by patients
Time Frame: At 1 month

Evaluate with questionnaire of knowledge, compose by 5 questions on three points each. The overall questionnaire will be on 15 points.

Higher scores better outcome.

At 1 month
Evaluate the user experience when using the digital tool MEDIASCREEN.
Time Frame: At 1 month
Measured by Questionnaire Attrakdiff for the user experience. The AttrakDiff questionnaire contains 28 question with 7 Likert-type scale from -3 to 3.
At 1 month
Evaluate the observance when using the digital tool MEDIASCREEN.
Time Frame: At 1 month
Measured by the connexion data : number of connexion, duration of connexion, percentage of completion.
At 1 month
Evaluate the acceptability of the digital information tool MEDIASCREEN digital information tool or the paper information brochure.
Time Frame: At the beggining and at 1 month
The acceptability will be assessed using a 13-item questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) model. Each question is based on a Likert-type 5 point scale ranging from : 1=In total disagreement, 2= Somewhat disagree, 3= Neither agree nor disagree, 4= Somewhat agree, 5=In total agreement.
At the beggining and at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aurélie Duruflé, Pôle Saint Hélier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2022

Primary Completion (Actual)

January 16, 2025

Study Completion (Actual)

January 16, 2025

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A00520-43

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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