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Completed

NCT Number: NCT03956927

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-TPE

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

Other

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

Primary outcomes

  1. level of perceived utility of the S-TPE

    Time frame: Through study completion, an average of 9 months

    The level of perceived utility of S-TPE for patients and caregivers through self-administered Likert scale questionnaires

  2. Patient satisfaction: Likert scale

    Time frame: Through study completion, an average of 9 months

    The degree of patient satisfaction at the end of the simulation sequence by self-administered questionnaire with a Likert scale

  3. Organizational advantages and limitations

    Time frame: Through study completion, an average of 9 months

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: PRE-SIMPA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 21, 2019
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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