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NCT Number: NCT01717144

Education in Therapy of Parkinson's Disease

Parkinson's disease (PD) has considerable impact on motor, psychological and social activities and significantly affects the quality of life of patients and their families. To improve the medical care of PD patients, the investigator have developed an educational program specific to PD.

The principal aim of this study is to evaluate the therapeutic education Program, comparing the quality of life of PD patients with or without the educational program after six month and one year follow-up.

The secondary aims are to evaluate the evolution of motor and psychological states in these 2 groups of patients and to compare the medical costs.

This is a monocentric, comparative, prospective randomised study. The investigators will evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients with a traditional medical care. Quality of life of PD patients is evaluated using a specific scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological states were assessed with UPDRS and HAD Scales. The educational program consisted of both individual and collective educational consultations.

The investigators supposed that the therapeutic education program will improve the quality of life of PD patients. The supposition that this improvement will correlate with the motor and psychological states.

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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

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Toulouse

Toulouse, 31000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
  • Parkinson's disease patients with a score ≤4 on the Hoehn and Year scale
  • Patient without cognitive disorders
  • Patients treated with dopaminergic antiparkisonian drugs (L-DOPA, dopamine agonists,ICOMT…) or DBS stimulation (since at least 3 month)
  • Patients able to fulfil self-administered questionnaire
  • Patients affiliated to a social protection program

Exclusion criteria

  • - Patients suffering from an other pathology causing chronic pain (rheumatic disease, traumatic or orthopaedic pathologies…)
  • Parkinson's disease patients with a score>5 on the Hoehn and Yahr scale
  • Patients suffering of parkinsonism induce by drugs
  • Patients with important tremors during a OFF conditions
  • Patients ever included in another study
  • Patients with severe psychiatric disease
  • Patients under tutelage, curatelle or law protection
  • Patients included in an other clinical study
  • Patients unable to fulfil scales of the study

Treatment and study plan

therapeutic education program

Behavioral

The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse

Primary outcomes

  1. Quality of life with the PDQ39 scale

    Time frame: 1 year

Secondary outcomes

  1. Quality of life with the SF36 scale

    Time frame: 1 year

  2. the motor state with UPDRS (Unified Pakinson's disease Rating Scale)

    Time frame: 1 year

  3. The psychological state with HAD (Hospital Anxiety and Depression) scale

    Time frame: 1 year

  4. Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale

    Time frame: 1 year

  5. Evaluation of medical costs

    Time frame: over the 12 months follow-up

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE

Acronym: ETPARK

Important dates

Study start
2008
Primary completion
2008
Study completion
2011
First posted
Oct 30, 2012
Registry last updated
May 12, 2017

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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