ClinicalTrials.gg
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.

Primary conditionPatient ComplianceRegistry: Chronic DiseaseReclassifiedWhy we changed it
Registry
Chronic Disease — the first condition term the registry derived for this study.
ClinicalTrials.gg
Patient Compliance
Why
  1. Chronic Disease is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Patient Compliance.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 55 studies in Patient Compliance with a site in France — 7 open to participants now, 9 under way, none of them phase 3. Patient Compliance · France.

Enrollment
5th of 28
459 · median 179
Started
2017
the only one that year
No phase
25 of 55
5 open now
Registered
24th of 55
by date
Lead sponsor
2 of 55
University Hospital, Lille

Among the 55 studies in Patient Compliance with a site in France, this one is the 5th largest by enrollment of the 28 interventional ones that give a count, is the only one that started in 2017, is one of 25 with no phase, and was the 24th registered.

Patient Compliance

752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.

Browse Patient Compliance studies →

Open to participants now

7 of the 55 studies in Patient Compliance with a site in France are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 55 studies in Patient Compliance with a site in France, or all of them as a file.
02

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.

03

Conditions studied

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

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Keywords

  • Psychological Theory
04

In context

Patient Compliance Reclassified

752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.

This study's enrollment of 459 is above the median of 116 across 527 interventional studies indexed under Patient Compliance.

Browse Patient Compliance studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Compared within Patient Compliance, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chronic Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Patients in jail
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

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.

07

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

08

Study locations

1 site
  • Hôpital Claude Huriez, CHU
    Lille, France
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Sep 2020, 32 months.

Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's 32 months is above that.

Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2017
First posted
Aug 21, 2017
StartActual
Dec 20, 2017
Primary completionActual
Sep 9, 2020
CompletionActual
Sep 9, 2020
Last update
Oct 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03255863
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 ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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