Clinical Trials/NCT01330290

NCT01330290CompletedNot Applicable

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

UCB Pharma54 sites in 1 country148 target enrollmentStarted: March 2011Last updated: December 10, 2013

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: UCB Pharma
Enrollment: 148
Locations: 54
Primary Endpoint: Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Observational
Observational Model: Cohort
Time Perspective: Cross Sectional

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Arms & Interventions

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®

Intervention: Neupro® (Drug)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption(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 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.)
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.)
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication(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(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 Dose Adaption(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(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(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(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(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(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(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(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(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(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(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.)

Investigators

Sponsor

UCB Pharma

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