NCT03255863

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. 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. 2.To test whether healthcare professionals' empathy impact patients' decision to participate in TPE
  3. 3.To test whether patients' intention to participate in TPE will predict their actual participation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2020

Completed
Last Updated

October 17, 2022

Status Verified

August 1, 2020

Enrollment Period

2.7 years

First QC Date

August 16, 2017

Last Update Submit

October 14, 2022

Conditions

Keywords

Psychological Theory

Outcome Measures

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.

    Baseline (after TPE proposal)

Secondary Outcomes (5)

  • Time limit of first proposition in TPE

    Baseline

  • Timeout of first participation in TPE

    Baseline

  • Medical context in which TPE is proposed

    Baseline

  • Consultation And Relational Empathy (CARE) questionnaire

    Baseline

  • Visual analog scale for intention to participated

    Baseline

Study Arms (1)

Questionnaire

OTHER

Auto and hetero questionnaire

Other: Questionnaire

Interventions

Patient Self reported questionnaire filled in.

Questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

Location

MeSH Terms

Conditions

Chronic DiseasePatient Compliance

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Maryline Bourgoin

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 21, 2017

Study Start

December 20, 2017

Primary Completion

September 9, 2020

Study Completion

September 9, 2020

Last Updated

October 17, 2022

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations