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

Pressure Sore Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547295
• Other study ID #: 2022-A00520-43
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: July 26, 2024

Study information

• Verified date: January 2024
• Source: Pôle Saint Hélier
• Contact: Philippe Gallien
• Phone: 02.99.29.50.21
• Email: philippe.gallien[@]pole-sthelier.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 26, 2024
• Est. primary completion date: July 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Sore
• Pressure Ulcer

Intervention

Other:
• Numeric prevention
Numeric information for prevention of pressure sores thgrough digital tool MEDIASCREEN
• Paper prevention
Information for prevention of pressure sores in classic way with paper

Locations

Country	Name	City	State
France	Pôle Saint-Hélier	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Pôle Saint Hélier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At 1 month
Secondary	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.	At the beginning and at 1 month
Secondary	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.	At the beginning and at 1 month
Secondary	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.	At 1 month
Secondary	Evaluate the occurrence of pressure sores during hospitalization	Count of the apparition number of pressure sores.	At the beginning and at 1 month
Secondary	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.	At 1 month
Secondary	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.	At 1 month
Secondary	Evaluate the observance when using the digital tool MEDIASCREEN.	Measured by the connexion data : number of connexion, duration of connexion, percentage of completion.	At 1 month
Secondary	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.	At the beggining and at 1 month