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

NCT03956927 | Completed

• 1 other identifier: PENNECOT 2019
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

patients

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

Other: S-TPE; Other: Questionnaires

Interventions

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.

patients

Questionnaires OTHER

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

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients

You may qualify if:

• 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®.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

• Pennecot C, Luu M, Marchand C, Gagnayre R, Dechannes N, Rudoni S, Hilaire AM, Demongeot A, Capelle D, Bardou M. First use of Simulation in Therapeutic Patient Education (S-TPE) in adults with diabetes: a pilot study. BMJ Open. 2022 Feb 28;12(2):e049454. doi: 10.1136/bmjopen-2021-049454.

  PMID: 35228274 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: May 24, 2019
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

FR (1)