Trial Outcomes & Findings for Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support (NCT NCT01330290)
NCT ID: NCT01330290
Last Updated: 2013-12-10
Results Overview
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.
COMPLETED
148 participants
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.
2013-12-10
Participant Flow
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).
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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148
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Overall Study
COMPLETED
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148
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support
Baseline characteristics by cohort
| Measure |
Neupro® Treatment
n=148 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=93 Participants
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Age, Categorical
Between 18 and 65 years
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17 Participants
n=93 Participants
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Age, Categorical
>=65 years
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131 Participants
n=93 Participants
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Age Continuous
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74.61 years
STANDARD_DEVIATION 8.26 • n=93 Participants
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Sex: Female, Male
Female
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60 Participants
n=93 Participants
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Sex: Female, Male
Male
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88 Participants
n=93 Participants
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Region of Enrollment
Germany
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148 participants
n=93 Participants
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Weight
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73.43 kilogram
STANDARD_DEVIATION 14.71 • n=93 Participants
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Height
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168.39 centimeters
STANDARD_DEVIATION 10.28 • n=93 Participants
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Type of care-giving: Patient lives at nursing home
No
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108 participants
n=93 Participants
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Type of care-giving: Patient lives at nursing home
Yes
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16 participants
n=93 Participants
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Type of care-giving: Patient lives at nursing home
Missing
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24 participants
n=93 Participants
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PRIMARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=126 Averaged Assessments
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.
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|---|---|
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Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
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1.32 units on a scale
Standard Deviation 0.67
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PRIMARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=40 Averaged Assessments
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.
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|---|---|
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Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
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1.46 units on a scale
Standard Deviation 0.32
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SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.
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".
Outcome measures
| Measure |
Neupro® Treatment
n=147 Participants
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.
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|---|---|
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Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Applicable
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89 participants
|
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Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Not applicable
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57 participants
|
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Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Missing
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1 participants
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.
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".
Outcome measures
| Measure |
Neupro® Treatment
n=147 Participants
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.
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|---|---|
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Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Applicable
|
139 participants
|
|
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Not applicable
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7 participants
|
|
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Missing
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1 participants
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=30 Averaged Assessments
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.
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|---|---|
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Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
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1.59 units on a scale
Standard Deviation 0.82
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SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=30 Averaged Assessments
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.
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|---|---|
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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.
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1.48 units on a scale
Standard Deviation 0.54
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SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=40 Averaged Assessments
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.
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|---|---|
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Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
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1.36 units on a scale
Standard Deviation 0.59
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SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=40 Averaged Assessments
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.
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|---|---|
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Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
|
1.48 units on a scale
Standard Deviation 0.60
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SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=35 Averaged Assessments
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.
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|---|---|
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Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia
|
1.87 units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=27 Averaged Assessments
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.
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|---|---|
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Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption
|
1.35 units on a scale
Standard Deviation 0.75
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=40 Averaged Assessments
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.
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|---|---|
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Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
|
1.50 units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=40 Averaged Assessments
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.
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|---|---|
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Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
|
1.37 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=40 Averaged Assessments
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.
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|---|---|
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Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments
|
1.15 units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=40 Averaged Assessments
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.
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|---|---|
|
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption
|
1.64 units on a scale
Standard Deviation 0.55
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=68 Averaged Assessments
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.
|
|---|---|
|
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
|
1.44 units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=60 Averaged Assessments
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.
|
|---|---|
|
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
|
1.50 units on a scale
Standard Deviation 0.91
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=127 Averaged Assessments
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.
|
|---|---|
|
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
|
1.33 units on a scale
Standard Deviation 0.93
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=123 Averaged Assessments
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.
|
|---|---|
|
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
|
1.49 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=126 Averaged Assessments
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.
|
|---|---|
|
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
|
1.54 units on a scale
Standard Deviation 0.77
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=124 Averaged Assessments
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.
|
|---|---|
|
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
|
1.19 units on a scale
Standard Deviation 0.91
|
SECONDARY outcome
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.Population: The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.
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.
Outcome measures
| Measure |
Neupro® Treatment
n=126 Averaged Assessments
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.
|
|---|---|
|
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts
|
1.03 units on a scale
Standard Deviation 0.98
|
Adverse Events
Neupro® Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neupro® Treatment
n=148 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Palpitations
|
0.68%
1/148 • Number of events 1 • All Adverse Drug Reactions (ADRs) were collected at the time of data collection.
The physicians were asked to list on the corresponding registration form all Adverse Events (AEs) that were documented at the time of data collection and were asked to assess if the causal relationship to the application of Neupro was classified as Yes (=ADR) or No.
|
|
Psychiatric disorders
Hallucination
|
0.68%
1/148 • Number of events 1 • All Adverse Drug Reactions (ADRs) were collected at the time of data collection.
The physicians were asked to list on the corresponding registration form all Adverse Events (AEs) that were documented at the time of data collection and were asked to assess if the causal relationship to the application of Neupro was classified as Yes (=ADR) or No.
|
Additional Information
UCB Clinical Trials Call Center
UCB
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60