G20
Conditions
Interventions
Group 1: Characterization of Parkinson Patients in three Manage PD categories (1. optimal therapy, 2. non optimally treated, 3. non optimally treated and could benefit from non-oral follow-up therapy
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosed of having an Idiopathic Parkinson Disease (PD) according to the UK brain bank criteria and currently receiving oral levodopa therapy - Adult (18 years or older) male or female - According to clinical judgement, the patient understands the language of the provided patient questionnaires - Signed Patient Authorization Form to use and disclose personal health information or informed consent form if required
Exclusion criteria
Exclusion criteria: - In “off” stage at time of clinic visit - Participating in a concurrent clinical study - Current or past treatment with a device aided therapy for PD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients identified within each of the three categories of disease control based on the usage of the MANAGE PD tool: (1) currently well controlled, (2) not well controlled, might not yet need a device aided therapy or (3) not well controlled, might benefit from device aided therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of patients within each of the three categories identified in current standard practice based on clinical judgement by the treating physician: (1) patient is controlled on current medication, (2) patient is not controlled but does not need device aided therapy or (3) patient is not controlled and would benefit from device aided therapy) - Results (i.e., response to each question) of web-based MANAGE PD’s section 1 completed by the physician - Results (i.e., response to each question) of paper-based modified MANAGE PD self-assessment completed by the patient - Planned treatment change by each category following MANAGE PD tool categorization of patient’s disease control: no change, change in oral treatment, change to device aided therapy - Physician’s acceptance of the MANAGE PD tool measured by the physician’s satisfaction with the utility after use (Visual Analog Scale (VAS) from 0-10) - Patient’s acceptance of the paper-based modified MANAGE PD self-assessment measured by the patient’s satisfaction with the utility after use (Visual Analog Scale (VAS) from 0-10) - Time needed to complete the paper-based modified MANAGE PD self-assessment by the patient - Time needed to complete the online version of MANAGE PD’s section 1 and 2 separately by the physician | — |
Countries
Germany
Contacts
Public ContactCarolin Arlt
AbbVie Deutschland GmbH & Co. KG
Outcome results
None listed