UMIN-CTR Clinical Trial

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
Email	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
Email	jun.watanabe@abbvie.com

Sponsor
Institute	AbbVie GK
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032611