Feasibility of Simulation in Therapeutic Patient Education for Adult Diabetic Patients Using the Freestyle Libre® Device

NCT ID: NCT03956927

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2019-07-11

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.

Conditions

Insulin-Dependent Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients

Insulin-dependent diabetic patients who have participated in a full TPE program (3 sessions)

S-TPE

Intervention Type: OTHER

S-TPE stimulation session with groups of 8 patients. The simulation is performed by a single patient, the others are observers in a neighbouring room where the scene is projected.

Questionnaires

Intervention Type: OTHER

Pre- and post-simulation administration of self-efficacy and anxiety questionnaires (IASTA Y1 and Y2)

Interventions

S-TPE

S-TPE stimulation session with groups of 8 patients. The simulation is performed by a single patient, the others are observers in a neighbouring room where the scene is projected.

Intervention Type: OTHER

Questionnaires

Pre- and post-simulation administration of self-efficacy and anxiety questionnaires (IASTA Y1 and Y2)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourgogne

Dijon, , France

Countries

France

Other Identifiers

PENNECOT 2019

Identifier Type: -

Identifier Source: org_study_id