Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466739
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2007-04-26
Brief Title:
European Compliance Study in Parkinsons Disease
Sponsor:
South Glasgow University Hospitals NHS Trust
Organization:
South Glasgow University Hospitals NHS Trust
Study Overview
Official Title:
European Study of Therapeutic Compliance in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In both symptomatic and asymptomatic disease only about half of medicines are taken as prescribed1 Relatively little is known about how patients with Parkinsons disease take their medication One of the challenges in the management of Parkinsons disease is the prevention and treatment of involuntary movements23 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 Parkinsons 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
Detailed Description:
This is an observational study of how patients with Parkinsons 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 23 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
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 23 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None