Electronic Compliance Monitoring in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Electronic Monitoring cap
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Parkinson's Disease, pharmacology, compliance, dopaminergic