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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03255863
Other study ID # 2015_70
Secondary ID 2016-A02057-44
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2017
Est. completion date September 9, 2020

Study information

Verified date August 2020
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Therapeutic Patient Education (TPE) refers to programs that help patients to manage life with a chronic disease in the best possible way. In spite of the effectiveness of Therapeutic Patient Education, few patients uptake TPE when it is proposed to them. Therefore, our main aim was to identify patients' beliefs that will predict patients' uptake of TPE. According to the Health Belief Model, patient will participate in TPE if they perceive their disease as a serious threat (with possible serious complications), but which can be controlled however, and that TPE is efficient and represents little burden. Secondary aims are as follows: 1. To test whether the way TPE is presented to patients impact patients' decision to uptake TPE. The way TPE is presented comprises the time between diagnosis and the proposal of TPE, whether patient is a remission or crisis period in the disease, the time between the proposal and the next TPE session, and what is said by healthcare professionals to present TPE. 2. To test whether healthcare professionals' empathy impact patients' decision to participate in TPE 3. To test whether patients' intention to participate in TPE will predict their actual participation. The ultimate goal of the study is to identify patients whose beliefs will not favor participation in TPE in order to accompany those patients more carefully. Best practices will be proposed according the results.


Recruitment information / eligibility

Status Completed
Enrollment 459
Est. completion date September 9, 2020
Est. primary completion date September 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients to whom TPE was proposed in diabetes, hemophilia, obesity, cardiac failure, chronic inflammatory bowel disease, parkinson, rare diseases, epilepsy, peripheral arterial diseases - Belong to a social security scheme - Pregnant women to whom TPE for gestational diabetes is proposed Exclusion Criteria: - Cognitive impairment declared by healthcare professionals - Inpatients - Patients for whom TPE is coupled with rehabilitation - Psychiatric disorders - Patients who cannot give informed consent - Patients in jail

Study Design


Intervention

Other:
Questionnaire
Patient Self reported questionnaire filled in.

Locations

Country Name City State
France Hôpital Claude Huriez, CHU Lille

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient's intention to participated in TPE by a questionnaire based on the Health Belief Model Patient's participation in TPE : yes or no Participation is defined as the patient's intention to come expressly to the hospital for a first appointment dedicated to therapeutic education.
The main variables of the HBM will be analyzed: perceived threat of the pathology, perceived benefits and barriers to TPE, perceived patient control of its pathology.
Baseline (after TPE proposal)
Secondary Time limit of first proposition in TPE Time between date of diagnostic illness and date of first first proposition in TPE Baseline
Secondary Timeout of first participation in TPE Time between date of proposition and date of the program begin of TPE Baseline
Secondary Medical context in which TPE is proposed Medical context in acute phase versus phase of stabilization of the pathology Baseline
Secondary Consultation And Relational Empathy (CARE) questionnaire The patient's perceived empathy of the professional (s) who offered the TPE will be assessed by the CARE questionnaire Baseline
Secondary Visual analog scale for intention to participated Visual analog scale ranging from 0 "not at all intending to participate" to 100 "very strong intention to participate Measurement of the patient's intention to participate in the proposed TPE program Baseline
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