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

October 14, 2022 updated by: University Hospital, Lille

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

459

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lille, France
        • Hôpital Claude Huriez, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maryline Bourgoin, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2017

Primary Completion (Actual)

September 9, 2020

Study Completion (Actual)

September 9, 2020

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 14, 2022

Last Verified

August 1, 2020

More Information

Terms related to this study

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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