Clinical trial NCT03255863: Determinants of Patients' Uptake of Therapeutic Education Programme
Official title: Determinants of Patients' Uptake of Therapeutic Education Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Patient Education as Topic
Patient Adherence
Empathy
Quality of Healthcare
Keywords: Psychological Theory
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2017-08-21
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient's intention to participated in TPE by a questionnaire based on the Health Belief Model
timeFrame: Baseline (after TPE proposal)
Secondary outcomes:
measure: Time limit of first proposition in TPE
timeFrame: Baseline
measure: Timeout of first participation in TPE
timeFrame: Baseline
measure: Medical context in which TPE is proposed
timeFrame: Baseline
measure: Consultation And Relational Empathy (CARE) questionnaire
timeFrame: Baseline
measure: Visual analog scale for intention to participated
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Maryline Bourgoin
role: PRINCIPAL_INVESTIGATOR
References: