- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03255863
Determinants of Patients' Uptake of Therapeutic Education Programme (UTEP)
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:
- 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.
- To test whether healthcare professionals' empathy impact patients' decision to participate in TPE
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France
- Hôpital Claude Huriez, CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Questionnaire
Auto and hetero questionnaire
|
Patient Self reported questionnaire filled in.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's intention to participated in TPE by a questionnaire based on the Health Belief Model
Time Frame: Baseline (after TPE proposal)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time limit of first proposition in TPE
Time Frame: Baseline
|
Time between date of diagnostic illness and date of first first proposition in TPE
|
Baseline
|
Timeout of first participation in TPE
Time Frame: Baseline
|
Time between date of proposition and date of the program begin of TPE
|
Baseline
|
Medical context in which TPE is proposed
Time Frame: Baseline
|
Medical context in acute phase versus phase of stabilization of the pathology
|
Baseline
|
Consultation And Relational Empathy (CARE) questionnaire
Time Frame: Baseline
|
The patient's perceived empathy of the professional (s) who offered the TPE will be assessed by the CARE questionnaire
|
Baseline
|
Visual analog scale for intention to participated
Time Frame: Baseline
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maryline Bourgoin, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015_70
- 2016-A02057-44 (Other Identifier: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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