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NCT Number: NCT04228523

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toulouse University Hospital

Toulouse, Occitanie, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic education workshop

Other

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

Speaking Therapy

Other

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 outcomes

  1. Evolution of Drug representation in Patients : BMQ

    Time frame: Three months

    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".

  2. Evolution of Drug representation in Patients : Verbal association

    Time frame: Three months

    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 outcomes

  1. Drug representation in caregivers : Verbal association

    Time frame: Day 1

    Drug representation through verbal association tasks.

  2. Drug representation in caregivers : BMQ

    Time frame: Day 1

    Drug representation through the Believe about Medicines Questionnaire (BMQ). BMQ with eighteen items coded from 1 " "strongly agree" to 5 "strongly disagree".

  3. Knowledge about the disease

    Time frame: three months

    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

  4. Evolution in life quality : VAS

    Time frame: three months

    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

  5. Evolution in life quality : PDQ-(39)

    Time frame: three months

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • France Parkinson Association

Registry information

Official study title

Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients?

Acronym: ETPARK-REMED

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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