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

Overview

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.

Full Title of Study: “Therapeutic Education in Parkinson’s Disease: What Impact on Drug Representations of Patients?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2021

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.

Interventions

  • Other: Therapeutic education workshop
    • 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
  • Other: Speaking Therapy
    • 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.

Arms, Groups and Cohorts

  • Experimental: Therapeutic education workshop
    • Two group receive therapeutic education workshop already existing in Toulouse University Hospital
  • Other: Speaking Therapy
    • One group receive speaking therapy already existing in Toulouse University Hospital

Clinical Trial Outcome Measures

Primary Measures

  • 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”.
  • 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 Measures

  • Drug representation in caregivers : Verbal association
    • Time Frame: Day 1
    • Drug representation through verbal association tasks.
  • 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”.
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Toulouse
  • Collaborator
    • France Parkinson Association
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christine Brefel-Courbon, MD, Principal Investigator, Univeristy Hospital Toulouse
  • Overall Contact(s)
    • Christine Brefel-Courbon, MD, PHD, 05 61 14 59 62, christine.brefel-courbon@univ-tlse3.fr

References

Canivet C, Costa N, Ory-Magne F, Arcari C, Mohara C, Pourcel L, Derumeaux H, BĂ©rard 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.

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.

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