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Determinants of Patients' Uptake of Therapeutic Education Programme (UTEP)

Primary Purpose

Chronic Disease, Patient Education as Topic, Patient Adherence

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Disease focused on measuring Psychological Theory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Claude Huriez, CHU

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Questionnaire

Arm Description

Auto and hetero questionnaire

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time limit of first proposition in TPE
Time between date of diagnostic illness and date of first first proposition in TPE
Timeout of first participation in TPE
Time between date of proposition and date of the program begin of TPE
Medical context in which TPE is proposed
Medical context in acute phase versus phase of stabilization of the pathology
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
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

Full Information

First Posted
August 16, 2017
Last Updated
October 14, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT03255863
Brief Title
Determinants of Patients' Uptake of Therapeutic Education Programme
Acronym
UTEP
Official Title
Determinants of Patients' Uptake of Therapeutic Education Programme
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
September 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Patient Education as Topic, Patient Adherence, Empathy, Quality of Healthcare
Keywords
Psychological Theory

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
459 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Questionnaire
Arm Type
Other
Arm Description
Auto and hetero questionnaire
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Patient Self reported questionnaire filled in.
Primary Outcome Measure Information:
Title
Patient's intention to participated in TPE by a questionnaire based on the Health Belief Model
Description
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.
Time Frame
Baseline (after TPE proposal)
Secondary Outcome Measure Information:
Title
Time limit of first proposition in TPE
Description
Time between date of diagnostic illness and date of first first proposition in TPE
Time Frame
Baseline
Title
Timeout of first participation in TPE
Description
Time between date of proposition and date of the program begin of TPE
Time Frame
Baseline
Title
Medical context in which TPE is proposed
Description
Medical context in acute phase versus phase of stabilization of the pathology
Time Frame
Baseline
Title
Consultation And Relational Empathy (CARE) questionnaire
Description
The patient's perceived empathy of the professional (s) who offered the TPE will be assessed by the CARE questionnaire
Time Frame
Baseline
Title
Visual analog scale for intention to participated
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryline Bourgoin
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Claude Huriez, CHU
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Determinants of Patients' Uptake of Therapeutic Education Programme

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