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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)

Primary Purpose

Pressure Sore

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Numeric prevention
Paper prevention
Sponsored by
Pôle Saint Hélier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Sore

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pôle Saint-HélierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Paper Information

Numeric information from MEDIASCREEN

Arm Description

Patient will have classic paper information for prevention of pressure sores

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate patient satisfaction with the information delivered by the MEDIASCREEN digital tool
Measured by Visual Analogic scale from 0 to 100. Zero is represented : "Not at all satisfied" and 100 : "Completely satisfied". Higher scores better outcome.
Assess the cognitive impact of the prevention information delivered by MEDIASCREEN tool, on self-esteem.
Measured of self-esteem with Rosenberg scale. Score range : 10-40. High scores indicate high self esteem.
Assess the cognitive impact of the prevention information delivered by MEDIASCREEN tool, on sense of self-efficacy.
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.
Evaluate the psychological impact of information delivered from the tools
Measured by Visual Analogic scale from 0 to 100. Zero is represented : "No knowledge" and 100 : "Perfectly mastered subject". Higher scores better outcome.
Evaluate the occurrence of pressure sores during hospitalization
Count of the apparition number of pressure sores.
Evaluate the acquisition of knowledge by patients
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.
Evaluate the user experience when using the digital tool MEDIASCREEN.
Measured by Questionnaire Attrakdiff for the user experience. The AttrakDiff questionnaire contains 28 question with 7 Likert-type scale from -3 to 3.
Evaluate the observance when using the digital tool MEDIASCREEN.
Measured by the connexion data : number of connexion, duration of connexion, percentage of completion.
Evaluate the acceptability of the digital information tool MEDIASCREEN digital information tool or the paper information brochure.
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.

Full Information

First Posted
July 7, 2022
Last Updated
October 28, 2022
Sponsor
Pôle Saint Hélier
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1. Study Identification

Unique Protocol Identification Number
NCT05547295
Brief Title
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
Acronym
EDUCESCARRES
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pôle Saint Hélier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Sore

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paper Information
Arm Type
Other
Arm Description
Patient will have classic paper information for prevention of pressure sores
Arm Title
Numeric information from MEDIASCREEN
Arm Type
Experimental
Arm Description
Patient will have information for prevention of pressure sores throught the digital tool MEDIASCREEN
Intervention Type
Other
Intervention Name(s)
Numeric prevention
Intervention Description
Numeric information for prevention of pressure sores thgrough digital tool MEDIASCREEN
Intervention Type
Other
Intervention Name(s)
Paper prevention
Intervention Description
Information for prevention of pressure sores in classic way with paper
Primary Outcome Measure Information:
Title
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
Description
The comparison will be done with Skin-Management Needs Assessment Checklist score (SMNac). Minimum value =0, Maximum value = 100; higher score better outcome.
Time Frame
Change from baseline knowledge at 1 month
Secondary Outcome Measure Information:
Title
Evaluate patient satisfaction with the information delivered by the MEDIASCREEN digital tool
Description
Measured by Visual Analogic scale from 0 to 100. Zero is represented : "Not at all satisfied" and 100 : "Completely satisfied". Higher scores better outcome.
Time Frame
At 1 month
Title
Assess the cognitive impact of the prevention information delivered by MEDIASCREEN tool, on self-esteem.
Description
Measured of self-esteem with Rosenberg scale. Score range : 10-40. High scores indicate high self esteem.
Time Frame
At the beginning and at 1 month
Title
Assess the cognitive impact of the prevention information delivered by MEDIASCREEN tool, on sense of self-efficacy.
Description
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.
Time Frame
At the beginning and at 1 month
Title
Evaluate the psychological impact of information delivered from the tools
Description
Measured by Visual Analogic scale from 0 to 100. Zero is represented : "No knowledge" and 100 : "Perfectly mastered subject". Higher scores better outcome.
Time Frame
At 1 month
Title
Evaluate the occurrence of pressure sores during hospitalization
Description
Count of the apparition number of pressure sores.
Time Frame
At the beginning and at 1 month
Title
Evaluate the acquisition of knowledge by patients
Description
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.
Time Frame
At 1 month
Title
Evaluate the user experience when using the digital tool MEDIASCREEN.
Description
Measured by Questionnaire Attrakdiff for the user experience. The AttrakDiff questionnaire contains 28 question with 7 Likert-type scale from -3 to 3.
Time Frame
At 1 month
Title
Evaluate the observance when using the digital tool MEDIASCREEN.
Description
Measured by the connexion data : number of connexion, duration of connexion, percentage of completion.
Time Frame
At 1 month
Title
Evaluate the acceptability of the digital information tool MEDIASCREEN digital information tool or the paper information brochure.
Description
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.
Time Frame
At the beggining and at 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Gallien
Phone
02.99.29.50.21
Email
philippe.gallien@pole-sthelier.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie Duruflé
Organizational Affiliation
Pôle Saint Hélier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pôle Saint-Hélier
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie Duruflé

12. IPD Sharing Statement

Learn more about this trial

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

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