UTEP: Determinants of Patients' Uptake of Therapeutic Education Programme

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03255863
• Collaborator: Ministry of Health, France (Other)
• Enrollment: 459
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42.3
• Patients Per Site Per Month: 10.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 459 participants
• Allocation: N/A
• 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: Dec 20, 2017
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient's intention to participated in TPE by a questionnaire based on the Health Belief Model [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 [Baseline]

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

2. Timeout of first participation in TPE [Baseline]

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

3. Medical context in which TPE is proposed [Baseline]

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

4. Consultation And Relational Empathy (CARE) questionnaire [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Claude Huriez, CHU	Lille		France

Sponsors and Collaborators

• University Hospital, Lille
• Ministry of Health, France

Investigators

• Principal Investigator: Maryline Bourgoin, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT03255863
• Other Study ID Numbers: 2015_70; 2016-A02057-44
• First Posted: Aug 21, 2017
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Chronic Disease

Study Results

No Results Posted as of Aug 26, 2020