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

Insulin-Dependent Diabetes Clinical Trial

— PRE-SIMPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956927
• Other study ID #: PENNECOT 2019
• Status: Completed
• Start date: May 24, 2019
• Est. completion date: July 11, 2019

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Insulin-Dependent Diabetes

Intervention

Other:
• 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.
• Questionnaires
Pre- and post-simulation administration of self-efficacy and anxiety questionnaires (IASTA Y1 and Y2)

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of perceived utility of the S-TPE	The level of perceived utility of S-TPE for patients and caregivers through self-administered Likert scale questionnaires	Through study completion, an average of 9 months
Primary	Patient satisfaction: Likert scale	The degree of patient satisfaction at the end of the simulation sequence by self-administered questionnaire with a Likert scale	Through study completion, an average of 9 months
Primary	Organizational advantages and limitations	Organizational, human, material, material and temporal facilities and limitations for patients and caregivers by analyzing the verbatim of the T0 questionnaires and interviewing them at T1	Through study completion, an average of 9 months