Clinical trial NCT01330290: Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine
Neupro®
Parkinson
Treatment preference
Care-giving
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-04-06
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
timeFrame: 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.
measure: Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
timeFrame: 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:
measure: Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
timeFrame: 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.
measure: Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
timeFrame: 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.
measure: Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
timeFrame: 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.
measure: 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.
timeFrame: 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.
measure: Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
timeFrame: 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.
measure: Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
timeFrame: 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.
measure: Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia
timeFrame: 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.
measure: Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption
timeFrame: 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.
measure: Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
timeFrame: 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.
measure: Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
timeFrame: 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.
measure: Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments
timeFrame: 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.
measure: Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption
timeFrame: 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.
measure: Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
timeFrame: 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.
measure: Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
timeFrame: 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.
measure: Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
timeFrame: 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.
measure: Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
timeFrame: 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.
measure: Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts
timeFrame: 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.
Other outcomes:
Locations:
city: Abensberg
country: Germany
facility: 52
city: Alzenau
country: Germany
facility: 53
city: Beelitz-Heilstätten
country: Germany
facility: 18
city: Bensheim
country: Germany
facility: 42
city: Berlin
country: Germany
facility: 24
city: Berlin
country: Germany
facility: 27
city: Celle
country: Germany
facility: 37
city: Dillingen
country: Germany
facility: 17
city: Dresden
country: Germany
facility: 48
city: Eisenach
country: Germany
facility: 32
city: Erbach
country: Germany
facility: 39
city: Erfurt
country: Germany
facility: 43
city: Essen
country: Germany
facility: 60
city: Geldern
country: Germany
facility: 38
city: Gelnhausen
country: Germany
facility: 5
city: Gelsenkirchen
country: Germany
facility: 40
city: Göttingen
country: Germany
facility: 31
city: Hagen
country: Germany
facility: 29
city: Halle
country: Germany
facility: 57
city: Halle
country: Germany
facility: 6
city: Hamm
country: Germany
facility: 28
city: Hannover
country: Germany
facility: 47
city: Herborn
country: Germany
facility: 7
city: Hoppegarten
country: Germany
facility: 55
city: Jena
country: Germany
facility: 59
city: Karlstadt
country: Germany
facility: 50
city: Konigsbruck
country: Germany
facility: 44
city: Köln
country: Germany
facility: 58
city: Lappersdorf
country: Germany
facility: 51
city: Lohr
country: Germany
facility: 8
city: Marktheidenfeld
country: Germany
facility: 4
city: Merzig
country: Germany
facility: 45
city: Minden
country: Germany
facility: 36
city: Mittweida
country: Germany
facility: 34
city: Muenchen
country: Germany
facility: 25
city: Mühldorf am Inn
country: Germany
facility: 35
city: München
country: Germany
facility: 41
city: Münster
country: Germany
facility: 30
city: Neuburg
country: Germany
facility: 49
city: Neumarkt
country: Germany
facility: 21
city: Niederschoena
country: Germany
facility: 13
city: Oschatz
country: Germany
facility: 9
city: Schorndorf
country: Germany
facility: 54
city: Schriesheim
country: Germany
facility: 2
city: Stralsund
country: Germany
facility: 1
city: Stratroda
country: Germany
facility: 12
city: Stuttgard
country: Germany
facility: 15
city: Stuttgart
country: Germany
facility: 33
city: Ulm
country: Germany
facility: 20
city: Unterhaching
country: Germany
facility: 14
city: Weil Am Rhein
country: Germany
facility: 22
city: Westerstede
country: Germany
facility: 11
city: Wolfach
country: Germany
facility: 23
city: Wolfratshausen
country: Germany
facility: 56
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.