Chronic DiseaseUTEPNCT03255863
Determinants of Patients' Uptake of Therapeutic Education Programme
A study testing Questionnaire in people with Chronic Disease and Patient Education as Topic, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Patient Education as Topic, Patient Adherence
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2017to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- Conditions
- Chronic Disease, Patient Education as Topic, Patient Adherence, Empathy, Quality of Healthcare
- Being tested
- Questionnaire
- Keywords
- Psychological Theory
- Medical subject headings
- Chronic Disease, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patient Self reported questionnaire filled in.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Other | Auto and hetero questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (after TPE proposal)
Secondary outcomes (5)
Time limit of first proposition in TPE
Time between date of diagnostic illness and date of first first proposition in TPE
Measured: Baseline
Timeout of first participation in TPE
Time between date of proposition and date of the program begin of TPE
Measured: Baseline
Medical context in which TPE is proposed
Medical context in acute phase versus phase of stabilization of the pathology
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start20 Dec 2017
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Maryline Bourgoin, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255863
- Sponsor's protocol ID
- 2015_70
- Other IDs
- 2016-A02057-44
- Acronym
- UTEP
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2017
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Patients' Uptake of Therapeutic Education Programme
- ClinicalTrials.gov ID
- NCT03255863
- Acronym / sponsor ID
- UTEP / 2015_70
- Conditions
- Chronic Disease, Patient Education as Topic, Patient Adherence, Empathy, Quality of Healthcare
- Keywords
- Psychological Theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | Other | Other: QuestionnaireAuto and hetero questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Cognitive impairment declared by healthcare professionals
- Inpatients
- Patients for whom TPE is coupled with rehabilitation
- Psychiatric disorders
- Patients who cannot give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatient Self reported questionnaire filled in. | Other | Questionnaire |
Primary outcome
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.
5 secondary outcomes
Time limit of first proposition in TPE
Time frame: Baseline
Timeout of first participation in TPE
Time frame: Baseline
Medical context in which TPE is proposed
Time frame: Baseline
Consultation And Relational Empathy (CARE) questionnaire
Time frame: Baseline
Visual analog scale for intention to participated
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryline Bourgoin principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Chronic Disease and Patient Education as Topic, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's intention to participated in TPE by a questionnaire based on the Health Belief Model (time frame: Baseline (after TPE proposal)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.