UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028490 |
|---|---|
| Receipt number | R000032611 |
| Scientific Title | A non-interventional, observational, cross-sectional study to assess the impact of Parkinson's disease on quality of life of Parkinson's disease patients and their caregivers in Japan. |
| Date of disclosure of the study information | 2017/08/14 |
| Last modified on | 2020/05/26 15:28:05 |
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Basic information
Public title
A non-interventional, observational, cross-sectional study to assess the impact of Parkinson's disease on quality of life of Parkinson's disease patients and their caregivers in Japan.
Acronym
A cross-sectional study to assess the impact of PD on QOL of PD patients and their caregivers in Japan.
Scientific Title
A non-interventional, observational, cross-sectional study to assess the impact of Parkinson's disease on quality of life of Parkinson's disease patients and their caregivers in Japan.
Scientific Title:Acronym
A cross-sectional study to assess the impact of PD on QOL of PD patients and their caregivers in Japan.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to assess the impact of Parkinson's disease on QOL of PD patients and their caregivers in the Japanese population.
Basic objectives2
Others
Basic objectives -Others
To assess the impact of PD severity on QOL of PD patients in the Japanese population
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is PDQ-8 summary index score, PDQ-8 SI.
The primary indicator of PD severity is off-time period per day.
The secondary indicators of PD severity are original H&Y stage, presence of wearing-off (WOQ-9 score), troublesome dyskinesia period per day, motor symptoms (SE-ADL score) and NMS (NMSQ total score).
Key secondary outcomes
The secondary endpoints are as follows:
- EQ-5D-5L index value
- PDQ-carer summary index, PDQ-carer SI
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients, who fulfill the following selection criteria, can be included:
- Adult patients with confirmed diagnosis of idiopathic Parkinson's disease
- Willingness and ability to provide informed consent
Caregivers, who fulfill the following selection criteria, can be included:
- Caregivers who are currently taking care of adult patients with confirmed diagnosis of idiopathic Parkinson's disease
- Willingness and ability to provide informed consent
Key exclusion criteria
Information from caregivers of patients who have not provided informed consent will not be included.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Miwami |
Organization
AbbVie GK
Division name
Medical Affairs
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo 108-6302, Japan
TEL
03-4577-1111
osamu.mikami@abbvie.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
AbbVie GK
Division name
Medical Affairs
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo 108-6302, Japan
TEL
080-3444-1687
Homepage URL
jun.watanabe@abbvie.com
Sponsor or person
Institute
AbbVie GK
Institute
Department
Personal name
Funding Source
Organization
AbbVie GK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS IRB
Address
Mita 5-20-9-401, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
YES
Study ID_1
11563
Org. issuing International ID_1
AbbVie GK
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
一般社団法人 全国パーキンソン病友の会（Japan Parkinson’s Disease Association）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The main purpose of this study is to assess the impact of Parkinson's disease on QOL of PD patients and their caregivers in the Japanese population. We expect increasing motor and NMS is associated with poor QOL among PD patients and their caregivers. The study is exploratory in nature and we assume no pre-specified hypotheses about statistical significance and/or direction of correlations.
The study population will consist of Parkinson's disease (PD) patients who belong to Japan Parkinson's Disease Association (JPDA) and their caregivers. This observational study will be performed in a cross-sectional, non-interventional, single-country format. The study will consist of a data-collection period with duration of 2 months. The questionnaires will be sent by mail to PD patients and their caregivers. Completed questionnaires will be collected anonymously by return mail.
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032611
| Research Plan | |
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| Research case data | |
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