- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05547295
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)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bretagne
-
Rennes, Bretagne, France, 35000
- Pôle Saint-Hélier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Aurélie Duruflé, Pôle Saint Hélier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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