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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Parkinson's Disease
• Intervention / Treatment: Drug: Neupro®

• Study Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• Germany
  • Abensberg, Germany
    • 52
  • Alzenau, Germany
    • 53
  • Beelitz-Heilstätten, Germany
    • 18
  • Bensheim, Germany
    • 42
  • Berlin, Germany
    • 24
  • Berlin, Germany
    • 27
  • Celle, Germany
    • 37
  • Dillingen, Germany
    • 17
  • Dresden, Germany
    • 48
  • Eisenach, Germany
    • 32
  • Erbach, Germany
    • 39
  • Erfurt, Germany
    • 43
  • Essen, Germany
    • 60
  • Geldern, Germany
    • 38
  • Gelnhausen, Germany
    • 5
  • Gelsenkirchen, Germany
    • 40
  • Göttingen, Germany
    • 31
  • Hagen, Germany
    • 29
  • Halle, Germany
    • 57
  • Halle, Germany
    • 6
  • Hamm, Germany
    • 28
  • Hannover, Germany
    • 47
  • Herborn, Germany
    • 7
  • Hoppegarten, Germany
    • 55
  • Jena, Germany
    • 59
  • Karlstadt, Germany
    • 50
  • Konigsbruck, Germany
    • 44
  • Köln, Germany
    • 58
  • Lappersdorf, Germany
    • 51
  • Lohr, Germany
    • 8
  • Marktheidenfeld, Germany
    • 4
  • Merzig, Germany
    • 45
  • Minden, Germany
    • 36
  • Mittweida, Germany
    • 34
  • Muenchen, Germany
    • 25
  • Mühldorf am Inn, Germany
    • 35
  • München, Germany
    • 41
  • Münster, Germany
    • 30
  • Neuburg, Germany
    • 49
  • Neumarkt, Germany
    • 21
  • Niederschoena, Germany
    • 13
  • Oschatz, Germany
    • 9
  • Schorndorf, Germany
    • 54
  • Schriesheim, Germany
    • 2
  • Stralsund, Germany
    • 1
  • Stratroda, Germany
    • 12
  • Stuttgard, Germany
    • 15
  • Stuttgart, Germany
    • 33
  • Ulm, Germany
    • 20
  • Unterhaching, Germany
    • 14
  • Weil Am Rhein, Germany
    • 22
  • Westerstede, Germany
    • 11
  • Wolfach, Germany
    • 23
  • Wolfratshausen, Germany
    • 56

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients not fulfilling the inclusion criteria
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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®	Drug: 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.; Other Names: Rotigotine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support	The physician was asked if he / she prescribed Neupro® due to substance in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were "applicable" and "not applicable".	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	The physician was asked if he / she prescribed Neupro® due to application form in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were "applicable" and "not applicable".	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	This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
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.	This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance	This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication	This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia	This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption	This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration	This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients	This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments	This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption	This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia	This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
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	This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance	This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication	This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration	This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients	This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts	This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score 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.

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

General Publications

• 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.

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 18, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (Estimate): April 6, 2011

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: November 7, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Parkinson; Rotigotine; Neupro®; Treatment preference; Care-giving
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: SP0939