Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support (CARE-ACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01330290
First received: March 18, 2011
Last updated: November 7, 2013
Last verified: November 2013
Results First Received: July 19, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Idiopathic Parkinson's Disease
Intervention: Drug: Neupro®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients participating in this study were in need of care either by family members at home or by professional nurses in outpatient care or nursing homes. The Participant Flow refers to the Enrolled Set (ES). All patients who were entered into the database are included in the Enrolled Set (ES).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The physicians were instructed to select idiopathic Parkinson's Disease (iPD) patients with documented need of care with caregivers/nurses who attended patients at home as caregiving family members or as professional nurses in outpatient care or nursing homes.

Reporting Groups
  Description
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®

Neupro® : 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.


Participant Flow:   Overall Study
    Neupro® Treatment  
STARTED     148  
COMPLETED     148 [1]
NOT COMPLETED     0  
[1] As this is a cross-sectional study, the terms completed/not completed are not applicable.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Baseline Characteristics refer to the Enrolled Set (ES). All patients who were entered into the database are included in the Enrolled Set (ES).

Reporting Groups
  Description
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®

Neupro® : 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.


Baseline Measures
    Neupro® Treatment  
Number of Participants  
[units: participants]
  148  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     131  
Age  
[units: years]
Mean ± Standard Deviation
  74.61  ± 8.26  
Gender  
[units: participants]
 
Female     60  
Male     88  
Region of Enrollment  
[units: participants]
 
Germany     148  
Weight  
[units: kilogram]
Mean ± Standard Deviation
  73.43  ± 14.71  
Height  
[units: centimeters]
Mean ± Standard Deviation
  168.39  ± 10.28  
Type of care-giving: Patient lives at nursing home  
[units: participants]
 
No     108  
Yes     16  
Missing     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication   [ Time Frame: 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. ]

2.  Primary:   Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication   [ Time Frame: 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. ]

3.  Secondary:   Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support   [ Time Frame: 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. ]

4.  Secondary:   Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support   [ Time Frame: 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. ]

5.  Secondary:   Score for the Physicians’ Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia   [ Time Frame: 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. ]

6.  Secondary:   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.   [ Time Frame: 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. ]

7.  Secondary:   Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance   [ Time Frame: 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. ]

8.  Secondary:   Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication   [ Time Frame: 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. ]

9.  Secondary:   Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia   [ Time Frame: 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. ]

10.  Secondary:   Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption   [ Time Frame: 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. ]

11.  Secondary:   Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration   [ Time Frame: 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. ]

12.  Secondary:   Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients   [ Time Frame: 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. ]

13.  Secondary:   Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments   [ Time Frame: 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.  Secondary:   Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption   [ Time Frame: 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. ]

15.  Secondary:   Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia   [ Time Frame: 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. ]

16.  Secondary:   Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting   [ Time Frame: 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. ]

17.  Secondary:   Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance   [ Time Frame: 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. ]

18.  Secondary:   Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication   [ Time Frame: 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. ]

19.  Secondary:   Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration   [ Time Frame: 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. ]

20.  Secondary:   Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients   [ Time Frame: 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. ]

21.  Secondary:   Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts   [ Time Frame: 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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trials Call Center
Organization: UCB
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01330290     History of Changes
Other Study ID Numbers: SP0939
Study First Received: March 18, 2011
Results First Received: July 19, 2013
Last Updated: November 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices