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Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients? (ETPARK-REMED) (ETPARK-REMED)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic education workshop
Speaking Therapy
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Therapeutic education, Parkinson Disease, Socials representations

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Parkinson's disease according to the United Kingdom Parkinson Disease Society Brain Bank (UKPDSBB) criteria,
  • Patients who are already in therapeutic education program ETPARK,
  • Patients who need and want to participate in therapeutic education workshop on Parkinson disease drug,
  • Patients with health insurance,
  • Patients who have signed a written informed consent form.

Exclusion Criteria:

  • Patients suffering from another parkinsonian syndrome (multiple system atrophy, progressive supranuclear palsy etc.),
  • Patients who has already done workshop on Parkinson disease drug (program ETPARK)
  • Patients already included in clinical trial during the study,
  • Patients who have severe psychiatric disorders or dopaminergic psychosis,
  • Patients with cognitive impairment,
  • Patients unable to complete the various scales used in the study,
  • Patients under juridical protection,
  • Women pregnant or breastfeeding.

Sites / Locations

  • Toulouse University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Therapeutic education workshop

Speaking Therapy

Arm Description

Two group receive therapeutic education workshop already existing in Toulouse University Hospital

One group receive speaking therapy already existing in Toulouse University Hospital

Outcomes

Primary Outcome Measures

Evolution of Drug representation in Patients : BMQ
Evolution of Drug representation through the Believe about Medicines Questionnaire (BMQ) compared to the control group. Evolution will be compared between the Baseline and the end of the study BMQ with eighteen items coded from 1 " "strongly agree" to 5 "strongly disagree".
Evolution of Drug representation in Patients : Verbal association
Evolution of Drug representation through verbal association tasks compared to the control group. Evolution will be compared between the Baseline and the end of the study

Secondary Outcome Measures

Drug representation in caregivers : Verbal association
Drug representation through verbal association tasks.
Drug representation in caregivers : BMQ
Drug representation through the Believe about Medicines Questionnaire (BMQ). BMQ with eighteen items coded from 1 " "strongly agree" to 5 "strongly disagree".
Knowledge about the disease
Evolution between Baseline and three months with a test created for the study. The test have 8 questions with two answers possible : True or False
Evolution in life quality : VAS
Evolution in life quality evaluate with Visual Analog Scale (VAS), 0 being the worst quality of life and 10 the best quality of life he can have. Evolution between Baseline and three months
Evolution in life quality : PDQ-(39)
Evolution in life quality evaluate with Parkinson Disease Quotation (PDQ)-39 with thirty-nine items coded from 1 " "always" to 5 "never". The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Evolution between Baseline and three months

Full Information

First Posted
January 9, 2020
Last Updated
August 24, 2023
Sponsor
University Hospital, Toulouse
Collaborators
France Parkinson Association
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1. Study Identification

Unique Protocol Identification Number
NCT04228523
Brief Title
Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients? (ETPARK-REMED)
Acronym
ETPARK-REMED
Official Title
Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
France Parkinson Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management. This study tries to evaluate the effect of therapeutic education workshop on Parkinson disease's drug (drug workshop) on the evolution of drug's representations in patients with Parkinson's disease compared to a control group.
Detailed Description
Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management. The therapeutic educational program ETPARK includes individual's consults or workshop. The team frequently offer to patients to participate in workshop on Parkinson disease's drug. This study tries to evaluate the effect of therapeutic education workshop on Parkinson disease's drug (drug workshop) on the evolution of drug's representations in patients with Parkinson's disease compared to a control group (speaking group) at 1 and 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Therapeutic education, Parkinson Disease, Socials representations

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
therapeutic education or speaking group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic education workshop
Arm Type
Experimental
Arm Description
Two group receive therapeutic education workshop already existing in Toulouse University Hospital
Arm Title
Speaking Therapy
Arm Type
Other
Arm Description
One group receive speaking therapy already existing in Toulouse University Hospital
Intervention Type
Other
Intervention Name(s)
Therapeutic education workshop
Intervention Description
Workshop on Parkinson disease drug has several educative sequences (lasting 4hours). A first round table is organized to know the needs and issues related to drug management of patients. The 1st educative sequence consists in knowing the different class of dopaminergic drugs and their action. The 2nd educative sequence leads patients to understand their prescription and be aware of the needs to take pills regularly. The 3rd educative sequence consists in learning and identifying potentials adverse effects and finds effective strategies to prevent them. At the end, one patient explains its tips and tricks about its drug management
Intervention Type
Other
Intervention Name(s)
Speaking Therapy
Intervention Description
Speaking group is leaded by a psychologist from Centre Expert Parkinson (lasting 2 hours). This specific time is an exchange between patients with Parkinson disease who feel free to come. It is about sharing its own experience. It is a very special moment, confidential and kindly where patients don't judge themselves and speak only if they want to.
Primary Outcome Measure Information:
Title
Evolution of Drug representation in Patients : BMQ
Description
Evolution of Drug representation through the Believe about Medicines Questionnaire (BMQ) compared to the control group. Evolution will be compared between the Baseline and the end of the study BMQ with eighteen items coded from 1 " "strongly agree" to 5 "strongly disagree".
Time Frame
Three months
Title
Evolution of Drug representation in Patients : Verbal association
Description
Evolution of Drug representation through verbal association tasks compared to the control group. Evolution will be compared between the Baseline and the end of the study
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Drug representation in caregivers : Verbal association
Description
Drug representation through verbal association tasks.
Time Frame
Day 1
Title
Drug representation in caregivers : BMQ
Description
Drug representation through the Believe about Medicines Questionnaire (BMQ). BMQ with eighteen items coded from 1 " "strongly agree" to 5 "strongly disagree".
Time Frame
Day 1
Title
Knowledge about the disease
Description
Evolution between Baseline and three months with a test created for the study. The test have 8 questions with two answers possible : True or False
Time Frame
three months
Title
Evolution in life quality : VAS
Description
Evolution in life quality evaluate with Visual Analog Scale (VAS), 0 being the worst quality of life and 10 the best quality of life he can have. Evolution between Baseline and three months
Time Frame
three months
Title
Evolution in life quality : PDQ-(39)
Description
Evolution in life quality evaluate with Parkinson Disease Quotation (PDQ)-39 with thirty-nine items coded from 1 " "always" to 5 "never". The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Evolution between Baseline and three months
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Parkinson's disease according to the United Kingdom Parkinson Disease Society Brain Bank (UKPDSBB) criteria, Patients who are already in therapeutic education program ETPARK, Patients who need and want to participate in therapeutic education workshop on Parkinson disease drug, Patients with health insurance, Patients who have signed a written informed consent form. Exclusion Criteria: Patients suffering from another parkinsonian syndrome (multiple system atrophy, progressive supranuclear palsy etc.), Patients who has already done workshop on Parkinson disease drug (program ETPARK) Patients already included in clinical trial during the study, Patients who have severe psychiatric disorders or dopaminergic psychosis, Patients with cognitive impairment, Patients unable to complete the various scales used in the study, Patients under juridical protection, Women pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Brefel-Courbon, MD
Organizational Affiliation
Univeristy Hospital Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27685455
Citation
Canivet C, Costa N, Ory-Magne F, Arcari C, Mohara C, Pourcel L, Derumeaux H, Berard E, Bourrel R, Molinier L, Brefel-Courbon C. Clinical Impact and Cost-Effectiveness of an Education Program for PD Patients: A Randomized Controlled Trial. PLoS One. 2016 Sep 29;11(9):e0162646. doi: 10.1371/journal.pone.0162646. eCollection 2016.
Results Reference
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PubMed Identifier
24267951
Citation
Ory Magne F, Arcari C, Canivet C, Sarrail M, Fabre MH, Mohara C, Brefel Courbon C. [A therapeutic educational program in Parkinson's disease: ETPARK]. Rev Neurol (Paris). 2014 Feb;170(2):128-33. doi: 10.1016/j.neurol.2013.08.007. Epub 2013 Nov 20. French.
Results Reference
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Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients? (ETPARK-REMED)

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