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Education in Therapy of Parkinson's Disease

EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01717144
Acronym
ETPARK
Enrollment
120
Registered
2012-10-30
Start date
2008-12-31
Completion date
2011-04-30
Last updated
2017-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

therapeutic education, Parkinson's disease, quality of life

Brief summary

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.

Interventions

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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Quality of life with the PDQ39 scale1 year

Secondary

MeasureTime frame
Quality of life with the SF36 scale1 year
the motor state with UPDRS (Unified Pakinson's disease Rating Scale)1 year
The psychological state with HAD (Hospital Anxiety and Depression) scale1 year
Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale1 year
Evaluation of medical costsover the 12 months follow-up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026