Electronic Compliance Monitoring in Parkinson's Disease
Electronic Compliance Monitoring in Parkinson's Disease
Patients with Parkinson's Disease (PD) depend on medication for relief of motor symptoms, and
 for this reason are often assumed to medicate very carefully. Overall, medication adherence
 is very good, but a subset of 15 to 20% of cases take less than 80% of the total prescribed
 dose. However, irregular timing of drug ingestion is almost universal, perhaps contributed by
 fluctuating symptoms and drug regimen complexity. Pulsatile dopaminergic stimulation in the
 basal ganglia is implicated in the development and manifestation of motor complications of
 advancing PD. Irregular medication intake is likely to contribute to peaks and troughs in
 serum and brain drug levels. In other diseases, patient adherence to prescribed medication
 improves through simplifying drug regimens, providing additional education, counselling and
 behavioural approaches and providing reminder packaging. We tested the effect on the timing
 of medicine ingestion of an educational approach, in which patients were given detailed
 additional information about the continuous dopaminergic theory.
Patients attending a regional movement disorder clinic with idiopathic PD (by UK Brain Bank
 criteria) and prescribed one or more antiparkinson drug (including dopamine agonist or
 levodopa) were invited to participate. Patients who were unable to manipulate the electronic
 pill monitoring bottles, or whose compliance would be adversely affected by using the
 electronic pill monitoring bottles (e.g. those reliant on a compliance aid) were excluded.
 The study received ethics approval and signed consent was obtained. During the study
 medication was adjusted according to clinical need. The increase in levodopa equivalent units
 during the study period was calculated according to established formula[12].

 Baseline assessments of unified Parkinson's disease rating scale (UPDRS), Hoehn and Yahr,
 Schwab and England, mini-mental state examination, geriatric depression scale and quality of
 life score (PDQ 39) were performed. Clinical scoring was blind to patient group and performed
 in an 'on' state. The UPDRS 3 and adverse events were recorded at each visit. The quality of
 life score (PDQ 39) was repeated at the final visit.

 All antiparkinson drugs were monitored during two 3 month periods (before and after the
 educational intervention) using electronic monitoring pill bottles (MEMS®, Aardex,
 Switzerland), a device which records the time and date of bottle opening.

 Patients randomly assigned (computer generated and placed in opaque envelopes) to the active
 (counselled) group were given verbal and written information about the continuous
 dopaminergic theory, and written advice on optimal medicine timing tailored to their own drug
 regimen. The counselling explained that in health, brain dopamine is constant, and that
 fluctuations from Parkinson's medications should be minimised to simulate normal dopamine
 levels. Control patients received standard care, but also had medication intake monitored
 using the MEMS device.

 Timing compliance (the percentage of doses taken at the correct time interval) was calculated
 using time intervals which optimise the pharmacokinetic profile, plus a 25% allowance, eg. 3
 times daily medication is satisfactory at between 6 and 10 hours. Selegiline 5mg twice daily
 was excluded from analysis as the second dose is taken at lunchtime to avoid sleep
 disturbance.
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.