Pressure SoreEDUCESCARRESNCT05547295
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 study testing Numeric prevention and Paper prevention in people with Pressure Sore, run by Pôle Saint Hélier at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Sore
- What is being tested?
- Numeric prevention and Paper prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2022to 16 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pressure Sore
- Being tested
- Numeric prevention, Paper prevention
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numeric preventionOther
Numeric information for prevention of pressure sores thgrough digital tool MEDIASCREEN
Paper preventionOther
Information for prevention of pressure sores in classic way with paper
| Study group | Role | What they receive |
|---|---|---|
| Paper Information | Other | Patient will have classic paper information for prevention of pressure sores Receives: Other: Paper prevention |
| Numeric information from MEDIASCREEN | Experimental | Patient will have information for prevention of pressure sores throught the digital tool MEDIASCREEN Receives: Other: Numeric prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline knowledge at 1 month
Secondary outcomes (9)
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.
Measured: At 1 month
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.
Measured: At the beginning and at 1 month
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.
Measured: At the beginning and at 1 month
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.
Measured: At 1 month
Evaluate the occurrence of pressure sores during hospitalization
Count of the apparition number of pressure sores.
Measured: At the beginning and at 1 month
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.
Measured: At 1 month
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.
Measured: At 1 month
Evaluate the observance when using the digital tool MEDIASCREEN.
Measured by the connexion data : number of connexion, duration of connexion, percentage of completion.
Measured: At 1 month
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.
Measured: At the beggining and at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start27 Oct 2022
- Primary completion16 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure SoreStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie Duruflé, Principal investigator, Pôle Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547295
- Sponsor's protocol ID
- 2022-A00520-43
- Acronym
- EDUCESCARRES
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2022
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05547295
- Acronym / sponsor ID
- EDUCESCARRES / 2022-A00520-43
- Conditions
- Pressure Sore
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper Information | Other | Other: Paper preventionPatient will have classic paper information for prevention of pressure sores |
| Numeric information from MEDIASCREEN | Experimental | Other: Numeric preventionPatient will have information for prevention of pressure sores throught the digital tool MEDIASCREEN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Numeric preventionNumeric information for prevention of pressure sores thgrough digital tool MEDIASCREEN | Other | Numeric information from MEDIASCREEN |
| Paper preventionInformation for prevention of pressure sores in classic way with paper | Other | Paper Information |
Primary outcome
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.
9 secondary outcomes
Evaluate patient satisfaction with the information delivered by the MEDIASCREEN digital tool
Time frame: 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
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
Evaluate the psychological impact of information delivered from the tools
Time frame: At 1 month
Evaluate the occurrence of pressure sores during hospitalization
Time frame: At the beginning and at 1 month
Evaluate the acquisition of knowledge by patients
Time frame: At 1 month
Evaluate the user experience when using the digital tool MEDIASCREEN.
Time frame: At 1 month
Evaluate the observance when using the digital tool MEDIASCREEN.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie Duruflé principal investigator
Pôle Saint Hélier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Numeric prevention and Paper prevention in people with Pressure Sore, run by Pôle Saint Hélier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.