Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support
CARE-ACT
A Multi-site, Non-interventional, Cross-sectional Evaluation of the Caregivers' and the Physicians' Preferred Route of Administration and the Physicians' Rationale for the Choice of Neupro® in Patients With Parkinson Requiring Caregiver Support
1 other identifier
observational
148
1 country
54
Brief Summary
The study objective is to evaluate advantages and disadvantages of Neupro® versus oral anti-Parkinson medication by caregivers and physicians in idiopathic Parkinson's Disease patients requiring caregiver support in nursing home or outpatient care settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2011
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
December 10, 2013
CompletedDecember 10, 2013
November 1, 2013
1.4 years
March 18, 2011
July 19, 2013
November 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Secondary Outcomes (19)
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting.
Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
- +14 more secondary outcomes
Study Arms (1)
Neupro® Treatment
Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®
Interventions
Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed.
Eligibility Criteria
Idiopathic Parkinson's Disease (iPD) patients treated with a combination of L-dopa or other oral iPD drug and Neupro® for at least one month and requiring caregiver support documented as per medical records Every consecutive, eligible patient to be treated with Neupro® as per physician's decision
You may qualify if:
- Only patients having signed the consent form regarding study information, data transfer and data use
- The patients suffer from idiopathic Parkinson's Disease (iPD) treated with a combination of L-dopa or another oral iPD drug and Neupro® for at least one month
- The patients require caregiver support documented as per medical records (e.g. based on German level of care intensity 1 or greater)
- The decision to prescribe Neupro® must have been made by the physician independent of his/her decision to include the patient in the study
You may not qualify if:
- And according to Summary of Product Characteristics (SmPC): Hypersensitivity to the active substance or to any of the excipients, magnetic resonance tomography (MRT) or cardioversion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (54)
52
Abensberg, Germany
53
Alzenau in Unterfranken, Germany
18
Beelitz-Heilstätten, Germany
42
Bensheim, Germany
24
Berlin, Germany
27
Berlin, Germany
37
Celle, Germany
58
Cologne, Germany
17
Dillingen, Germany
48
Dresden, Germany
32
Eisenach, Germany
39
Erbach im Odenwald, Germany
43
Erfurt, Germany
60
Essen, Germany
5
Gelnhausen, Germany
40
Gelsenkirchen, Germany
31
Göttingen, Germany
38
Guelders, Germany
29
Hagen, Germany
57
Halle, Germany
6
Halle, Germany
28
Hamm, Germany
47
Hanover, Germany
7
Herborn, Germany
55
Hoppegarten, Germany
59
Jena, Germany
50
Karlstadt am Main, Germany
44
Königsbrück, Germany
51
Lappersdorf, Germany
8
Lohr, Germany
4
Marktheidenfeld, Germany
45
Merzig, Germany
36
Minden, Germany
34
Mittweida, Germany
35
Mühldorf, Germany
25
München, Germany
41
München, Germany
30
Münster, Germany
49
Neuburg am Inn, Germany
21
Neumarkt, Germany
13
Niederschöna, Germany
9
Oschatz, Germany
54
Schorndorf, Germany
2
Schriesheim, Germany
1
Stralsund, Germany
12
Stratroda, Germany
15
Stuttgard, Germany
33
Stuttgart, Germany
20
Ulm, Germany
14
Unterhaching, Germany
22
Weil am Rhein, Germany
11
Westerstede, Germany
23
Wolfach, Germany
56
Wolfratshausen, Germany
Related Publications (1)
Sieb JP, Themann P, Warnecke T, Lauterbach T, Berkels R, Grieger F, Lorenzl S. Caregivers' and physicians' attitudes to rotigotine transdermal patch versus oral Parkinson's disease medication: an observational study. Curr Med Res Opin. 2015 May;31(5):967-74. doi: 10.1185/03007995.2015.1030376.
PMID: 25772231DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trials Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2011
First Posted
April 6, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
December 10, 2013
Results First Posted
December 10, 2013
Record last verified: 2013-11