NCT04228523

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable parkinson-disease

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

January 9, 2020

Last Update Submit

April 29, 2026

Conditions

Keywords

Therapeutic educationParkinson DiseaseSocials representations

Outcome Measures

Primary Outcomes (2)

  • 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".

    Three months

  • 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

    Three months

Secondary Outcomes (5)

  • Drug representation in caregivers : Verbal association

    Day 1

  • Drug representation in caregivers : BMQ

    Day 1

  • Knowledge about the disease

    three months

  • Evolution in life quality : VAS

    three months

  • Evolution in life quality : PDQ-(39)

    three months

Study Arms (2)

Therapeutic education workshop

EXPERIMENTAL

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

Other: Therapeutic education workshop

Speaking Therapy

OTHER

One group receive speaking therapy already existing in Toulouse University Hospital

Other: Speaking Therapy

Interventions

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

Therapeutic education workshop

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.

Speaking Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse University Hospital

Toulouse, Occitanie, 31059, France

Location

Related Publications (1)

  • Faurie I, Harroch E, Scotto d'Apollonia C, Corte S, Arcari C, Mohara C, Barthelemy C, Fabre MH, Boussac M, Damase-Michel C, Almudever B, Croity-Belz S, Brefel-Courbon C. Impact of therapeutic education on the evolution of social representations of medication in patients with Parkinson's disease: A quantitative and qualitative study (ETPARK REMED). Rev Neurol (Paris). 2023 Dec;179(10):1086-1094. doi: 10.1016/j.neurol.2023.03.026. Epub 2023 Aug 24.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Christine Brefel-Courbon, MD

    Univeristy Hospital Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: therapeutic education or speaking group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 14, 2020

Study Start

February 24, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations