European Compliance Study in Parkinson's Disease
European Compliance Study in Parkinson's Disease
In both symptomatic and asymptomatic disease, only about half of medicines are taken as
 prescribed1. Relatively little is known about how patients with Parkinson's disease take
 their medication. One of the challenges in the management of Parkinson's disease is the
 prevention and treatment of involuntary movements2,3 and wild fluctuations between being
 mobile and able to function against being slow, stiff and unable to move which recurs as a
 delayed (several years) effect of taking antiparkinson medication. One theory of why this
 occurs is that it is due to pulsatile rather than continuous delivery of medication to the
 brain4. If patients take their medicines erratically and irregularly, this causes more
 fluctuations in blood and therefore brain drug levels may prime patients for complications in
 the future. This project will define the extent of irregular medication taking in Parkinson's
 disease, examine associated clinical and demographic characteristics and examine the ease of
 adherence to different drug regimes. Knowledge of therapy adherence will help support
 patients in using their medicines to best effect. In the present document the terms
 compliance and adherence are used with equal meaning.
This is an observational study of how patients with Parkinson's disease take their
 medication. Antiparkinson medication will be monitored using electronic pill bottles, MEMS,
 Aardex®, Switzerland (which contain a microprocessor in the cap that records the time and
 date of bottle openings). This gives information about the amount of prescribed medication
 taken (total compliance), the percentage of days when the correct number of doses is taken
 (daily compliance), and the percentage of doses taken at the correct time interval (timing
 compliance).

 Five countries will be involved, (UK, Germany, Italy, Spain and France). The total number of
 patients recruited across Europe will be 144. The study size has been calculated based on a
 single centre study in Glasgow where 2/3 of 120 patients were scheduled to undergo electronic
 monitoring as part of a different study design. Accordingly data is available which has
 informed the expected number of patients completing the study (around a 10% drop out rate)
 and in order to test 6 key variables with potential influence on therapy compliance and using
 the general statistical guide that between 10 and 20 patients should be studied per variable
 to be examined, a sample size of around 120 evaluable patients has been calculated.
Inclusion Criteria:

 -  Men or Women between 18 and 80 years.

 -  Patient has idiopathic Parkinson's Disease according to Brain Bank criteria. -
 Reference Hughes A J, Daniel S E, Kilford L, Lees A J, Accuracy of Clinical -
 Diagnosis of Idiopathic Parkinson's disease; A clinical Pathological study of 100
 cases, JNNP 1992, 55(3): 181 - 184

 -  Patient is on stable doses of anti-Parkinson's disease medication, which are not
 expected to change during the study period.

 -  Patient is taking levodopa and/or dopamine agonist treatment.

 -  Patient (assisted by a carer where appropriate) is able to take their medication using
 the MEMS (electronic monitoring) containers.

 -  Patients using a dosette box or similar device for their medication are willing to use
 the MEMS containers for their PD medication

 -  The investigator judges that the patient's care and symptom control will not be
 adversely affected by entering the study and using the MEMS device.

 Exclusion Criteria:

 -  Patient is taking anti-Parkinson's disease therapy intermittently or on "as required"
 basis (such as rescue therapy for off periods). Intermittent Domperidone is allowed.

 -  Severe co-morbid condition such as severe heart, liver, or kidney disease or cancer
 diagnosis where the co-morbid condition is of greater health significance than the
 Parkinson's disease in terms of life expectancy and levels of care required.

 -  Patient is expected to undergo hospital admission during the study period (such as
 elective surgery).

 -  Patient is on non standard drug treatment / combination therapy. This would include
 e.g. a combination of 2 different oral dopamine agonists, doses of dopamine agonist
 taken at higher than recommended for routine practice.

 -  New antiparkinson treatment is being introduced at the time of recruitment or during
 the one month monitoring period.

 -  Patient is taking only adjunct therapy (eg. Selegiline, Amantadine, anticholinergic
 therapy).

 -  Patient is taking part in a clinical trial.