Electronic Compliance Monitoring in Parkinson's Disease

NCT00361205 | Completed

• 1 other identifier: 2003/03
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease, pharmacology, compliance, dopaminergic

Outcome Measures

Primary Outcomes (1)

• Timing compliance

Secondary Outcomes (1)

• Parkinson motor scores

Interventions

Electronic Monitoring cap DEVICE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Glasgow University Hospitals NHS Trust: lead
• Neurosciences Foundation: collaborator

Related Publications (1)

• 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. doi: 10.1186/1471-2377-7-20.

  PMID: 17634109 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Patient Compliance

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Donald Grosset, MBChB, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2006
• First Posted: August 8, 2006
• Study Start: November 1, 2003
• Study Completion: September 1, 2005
• Last Updated: October 17, 2006

Record last verified: 2005-12