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: September 25, 2012
Last verified: September 2012

March 18, 2011
September 25, 2012
March 2011
August 2012   (final data collection date for primary outcome measure)
  • Mean score of the caregivers' rating of Neupro® compared to oral anti-Parkinson medication [ Time Frame: After at least one month of treatment with Rotigotine in combination with an oral IPD treatment, measurement (documentation) at a single time point ] [ Designated as safety issue: No ]
    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.
  • Mean score of the physicians' rating of Neupro® compared to oral anti-Parkinson medication [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01330290 on ClinicalTrials.gov Archive Site
  • Assessment of the physicians' rationale for the choice of Neupro® due to substance in idiopathic Parkinsons Disease patients requiring caregiver support [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
  • Assessment of the physicians' rationale for the choice of Neupro® due to application form in idiopathic Parkinsons Disease patients requiring caregiver support [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
  • 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: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to control of compliance [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • 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: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to surgery requiring general anaesthesia. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to dose adaption. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication with regard to independency of food administration. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication with regard to sleeping patients. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to risk of interaction with other treatments. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to resorption. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication in relation to dysphagia in patients with dysphagia. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • 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: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication in relation to control of compliance [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • 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: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication with regard to independency of food administration. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication with regard to sleeping patients. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
  • Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication in relation to care-giving efforts [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
    The response is rated on a 5-point scale from -2 to 2.
Same as current
Not Provided
Not Provided
 
Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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

Idiopathic Parkinson's Disease
Not Provided
Neupro® Treatment
Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24h) as per approved label in EU/in accordance with the terms of the local marketing authorization for Neupro®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Only patients having signed the consent form regarding study information, data transfer and data use
  • The patients suffer from 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.

Exclusion Criteria:

  • Patients not fulfilling the inclusion criteria
  • And according to SmPC: Hypersensitivity to the active substance or to any of the excipients, magnetic resonance tomography (MRT) or cardioversion
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01330290
SP0939
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP