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CompletedNCT03255863UTEPUpdated Oct 17, 2022

Determinants of Patients' Uptake of Therapeutic Education Programme

An interventional study of Questionnaire in Chronic Disease, Patient Education as Topic and Patient Adherence, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-17.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
459
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Disease
  • Patient Education as Topic
  • Patient Adherence
  • Empathy
  • Quality of Healthcare

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Keywords

  • Psychological Theory
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
459 participants (actual)

Study arms

  • Other
    Questionnaire

    Auto and hetero questionnaire

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    Patient Self reported questionnaire filled in.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (after TPE proposal)

Secondary outcomes

  1. Time limit of first proposition in TPE

    Time between date of diagnostic illness and date of first first proposition in TPE

    Time frame: Baseline

  2. Timeout of first participation in TPE

    Time between date of proposition and date of the program begin of TPE

    Time frame: Baseline

  3. Medical context in which TPE is proposed

    Medical context in acute phase versus phase of stabilization of the pathology

    Time frame: Baseline

  4. 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

    Time frame: Baseline

  5. 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

    Time frame: Baseline

06

Study locations

1 site
  • Hôpital Claude Huriez, CHU
    Lille, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03255863
Lead sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Dec 20, 2017
Primary completion
Sep 9, 2020
Completion
Sep 9, 2020
Last update
Oct 17, 2022

Study contacts

Maryline Bourgoin
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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