Clinical trial NCT03956927: Feasibility of Simulation in Therapeutic Patient Education for Adult Diabetic Patients Using the Freestyle Libre® Device
Official title: Feasibility of Simulation in Therapeutic Patient Education for Adult Diabetic Patients Using the Freestyle Libre® Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin-Dependent Diabetes
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients

Brief summary: The benefits of Therapeutic Patient Education (TPE) have long been proven, but its implementation remains insufficient. It is only accessible to a part of the population and is too often limited to the acquisition of knowledge. TPE consists of supporting the patient in making decisions about his or her health, managing his or her life with the disease and treatment through the acquisition or maintenance of skills.

Simulation is a pedagogical method of creating fictional or reconstructed environments in order to develop skills, know-how and abilities for which direct instruction is impossible for ethical, economic or technical reasons. To date, it is recommended for the development of caregiver skills, and has been the subject of two studies among family caregivers. It seems likely that simulation will add value to the methods currently used in TPE.

To our knowledge, no studies have been conducted on simulation-based TPE (S-TPE) with patients.

A consensus conference, which is a rigorous method of comparing the opinions of experts in TPE, simulation, patient experts and caregivers, was held in order to determine the learning that could be developed through simulation and the conditions of use. However, since the patient is a specific type of learner, we hypothesize that there may be some additional conditions for the use of S-TPE. And the value of this approach remains to be demonstrated. Since the use of S-TPE has never been studied with patients, a feasibility test would make it possible to evaluate, in the context of care, the possibility of its use and its acceptance by both patients and caregivers. This is necessary before considering a multicenter trial that demonstrates an interest in developing patient skills. It was decided to carry out this study in patients with diabetes, a condition for which TPE is a precursor. Caregivers will be able to objectify the advantages and limitations of using S-TPE.


Eligibility criteria: Inclusion Criteria:

* Adult who has provided non-opposition to participate in the study
* Insulin-dependent diabetic patient who has participated in a complete TPE program (3 sessions) for the implementation of a FreeStyle Libre®.

Exclusion Criteria:

* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to limited judicial protection
* Pregnant, parturient or breastfeeding woman
* Adulat patients unable to provide consent

Primary outcomes:
measure: level of perceived utility of the S-TPE
timeFrame: Through study completion, an average of 9 months
measure: Patient satisfaction: Likert scale
timeFrame: Through study completion, an average of 9 months
measure: Organizational advantages and limitations
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: