Télésurveillance de Patients Porteurs d'Une Plaie Chronique à l'Aide d'Une Solution numérique MyDerm : étude de faisabilité
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Response to questionnaire completed after two months of use
Study Overview
Brief Summary
The aim of this study is to assess the feasibility of integrating myDerm for remote monitoring of chronic wounds into everyday practice, for patients over 18 years of age suffering from a single chronic wound of the lower limb (more than 6 weeks old).
Outcome measure 1 :
Evaluate patient satisfaction after 2 months of using the MyDerm solution.
Outcome measure 2 :
- Evaluate caregiver satisfaction after 2 months of patient use of MyDerm solution.
- Assess patient use (compliance, frequency) of MyDerm solution
- Evaluate caregiver use of PIXACARE solution
- Evaluate the impact of patients' socio-demographic characteristics (age, gender, level of education: primary/secondary/tertiary, rural/urban) on use of the MyDerm solution.
- Evaluate the impact of patients' clinical characteristics on the use of the MyDerm solution.
Researchers will compare standard of care arm vs remote monitoring arm.
As part of remote monitoring, patients are invited to take photos of their wounds using their smartphone, and to answer a simple questionnaire to look for signs of complications. To assess satisfaction, the patient will complete a questionnaire after 2 months' use, using a 7-level Likert scale.
Detailed Description
Observational, monocentric study of patients with chronic wounds of the lower limb benefiting from the digital solution for remote monitoring of wound healing.
Clinical data will be collected by the investigating team during the primary consultation.
Patient satisfaction surveys will be sent in paper format to patients at the consultation scheduled at the end of the two-month follow-up period.
Caregiver" satisfaction surveys will be sent in paper format to caregivers at the end of the study.
The number of actions taken in response to an alert (by telephone, by message, organization of a physical consultation, organization of a teleconsultation, hospitalization) will be recorded in the post-alert action traceability form
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with a single chronic wound of the lower limb (more than 6 weeks)
- •Benefiting from the MyDerm digital wound-healing monitoring solution
- •Patient aged 18 or over
- •Informed patient who has not objected to the use of data
Exclusion Criteria
- •Patient refusing to participate in the study
- •Patient included in a clinical trial
- •Patient with a life expectancy shorter than the duration of the study
- •Patient with cognitive impairment
- •Inability to install or use the medical device for technical reasons (lack of internet connection, lack of 4G coverage or more, lack of smartphone)
- •Patient requiring home hospital care
- •Patient requiring Follow-up and rehabilitation care
- •Pregnant or breast-feeding women
- •Patient with a previously infected wound
Outcomes
Primary Outcomes
Response to questionnaire completed after two months of use
Time Frame: At 2 months
The satisfaction questionnaire using a 7-point Likert scale
Secondary Outcomes
- Use of PIXACARE solution by caregivers(At 2 months)
- Responses to the caregiver questionnaire completed at the end of the study using a 7-point Likert scale(At 2 months)
- Patient use of the MyDerm solution(At 2 months)
- The impact of patients' socio-demographic characteristics on use of the MyDerm solution(AT 2 months)