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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03255863
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : February 20, 2019
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Chronic Disease Patient Education as Topic Patient Adherence Empathy Quality of Healthcare Other: Questionnaire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 459 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Determinants of Patients' Uptake of Therapeutic Education Programme
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Auto and hetero questionnaire
Other: Questionnaire
Patient Self reported questionnaire filled in.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Time limit of first proposition in TPE [ Time Frame: Baseline ]
    Time between date of diagnostic illness and date of first first proposition in TPE

  2. Timeout of first participation in TPE [ Time Frame: Baseline ]
    Time between date of proposition and date of the program begin of TPE

  3. Medical context in which TPE is proposed [ Time Frame: Baseline ]
    Medical context in acute phase versus phase of stabilization of the pathology

  4. 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

  5. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03255863

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Contact: Maryline BOURGOIN 03 20 44 45 33 ext +33

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Hôpital Claude Huriez, CHU Recruiting
Lille, France
Sub-Investigator: Eric Hachulla, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
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Principal Investigator: Maryline Bourgoin University Hospital, Lille

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Responsible Party: University Hospital, Lille Identifier: NCT03255863     History of Changes
Other Study ID Numbers: 2015_70
2016-A02057-44 ( Other Identifier: ID-RCB number, ANSM )
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Psychological Theory
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes