Electronic Compliance Monitoring in Parkinson's Disease
|First Received Date ICMJE||August 7, 2006|
|Last Updated Date||October 16, 2006|
|Start Date ICMJE||November 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00361205 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Parkinson motor scores|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Electronic Compliance Monitoring in Parkinson's Disease|
|Official Title ICMJE||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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Condition ICMJE||Parkinson's Disease|
|Intervention ICMJE||Device: Electronic Monitoring cap|
|Study Arm (s)||Not Provided|
|Publications *||Grosset KA, Grosset DG. Effect of educational intervention on medication timing in Parkinson's disease: a randomized controlled trial. BMC Neurol. 2007 Jul 16;7:20.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||September 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 85 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00361205|
|Other Study ID Numbers ICMJE||2003/03|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||South Glasgow University Hospitals NHS Trust|
|Collaborators ICMJE||Neurosciences Foundation|
|Information Provided By||South Glasgow University Hospitals NHS Trust|
|Verification Date||December 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP