Feasibility of Simulation in Therapeutic Patient Education for Adult Diabetic Patients Using the Freestyle Libre® Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- level of perceived utility of the S-TPE
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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®.
排除标准
- •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
研究组 & 干预措施
patients
Insulin-dependent diabetic patients who have participated in a full TPE program (3 sessions)
干预措施: S-TPE (Other)
patients
Insulin-dependent diabetic patients who have participated in a full TPE program (3 sessions)
干预措施: Questionnaires (Other)
结局指标
主要结局
level of perceived utility of the S-TPE
时间窗: 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
Organizational advantages and limitations
时间窗: 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
Patient satisfaction: Likert scale
时间窗: 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
次要结局
未报告次要终点