UMIN-CTR Clinical Trial

Basic information
Public title	Questionnaire survey for perspectives of patients and doctors on diagnosis and treatment in Parkinson's disease; PD voice study
Acronym	PD voice study
Scientific Title	Questionnaire survey for perspectives of patients and doctors on diagnosis and treatment in Parkinson's disease; PD voice study
Scientific Title:Acronym	PD voice study
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.Investigation of factors causing delays in diagnosis and treatment initiation 2.Investigation of patients' low satisfaction with treatment
Basic objectives2	Others
Basic objectives -Others	1.The research will confirm the background details of diagnosis and treatment initiation and investigate the actual state and factors causing delays in diagnosis and treatment through questionnaire surveys of patients and doctors. 2. The research will investigate factors of patients' low satisfaction by analyzing their communications through questionnaire surveys of patients and doctors.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	<Survey of patients and their families> 1) Disease-related information2) Satisfaction with treatment, satisfaction with consultation 3) Factors inhibiting early diagnosis/early treatment4) Understanding of the disease5) Understanding of the symptoms 6) Awareness of the treatment <Survey of doctors> 1) Disease-related information2) Satisfaction with treatment, satisfaction with consultation 3) Factors inhibiting early diagnosis and early treatment4) Explanation of the disease5) Understanding of the symptoms6) Awareness of the treatment
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	<Patients and their families> Subjects must satisfy all of the following criteria. 1)The patient or his/her family had a diagnosis of PD and is visiting hospital. 2)Among 4 major symptoms of PD (postural instability,tremor,rigidity,bradykinesia),the patient (patient or his/her family) has 2 symptoms including bradykinesia. 3)In case of patient's family, he or she can live with the patient and respond on behalf of the patient. <Doctors> Subjects must satisfy one of the following criteria according to affiliated department. 1)Neurologists who examined 25 PD patients or more during the last 6 months. 2)Neurosurgeons who examined 5 PD patients or more during the last 6 months. 3)Doctors other than 1) and 2) who examined 10 PD patients or more during the last 6 months.
Key exclusion criteria	no matching the key inclusion criteria
Target sample size	700

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Masahiro Nomoto
Organization	The Social Welfare Organization Imperial Gift Foundation Inc, Saiseikai Imabari Center for Health and Welfare
Division name	Department of Neurology
Zip code
Address	7-6-1 Kitamura, Imabari, Ehime
TEL	0898-47-2500
Email	m-nomoto@imabari.saiseikai.or.jp

Public contact
1st name of contact person	1st name Middle name Last name Takayuki Ishida
Organization	Takeda Pharmaceutical Company Limited
Division name	Japan Medical Affairs
Zip code
Address	12-10, Nihonbashi 2-chome, Chuo-ku, Tokyo 103-8668
TEL	03-3278-1256
Homepage URL
Email	takayuki.ishida@takeda.com

Sponsor
Institute	Takeda Pharmaceutical Company, Limited Japan Medical Affairs
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company, Limited Japan Medical Affairs
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
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	株式会社マクロミルケアネット (MACROMILL CARENET,INC.)

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 10 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	Completed
Date of protocol fixation	2019 Year 02 Month 01 Day
Date of IRB	2019 Year 02 Month 15 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 22 Day
Date of closure to data entry	2019 Year 03 Month 26 Day
Date trial data considered complete	2019 Year 03 Month 26 Day
Date analysis concluded	2019 Year 04 Month 22 Day

Other
Other related information	This observational study will be performed in a cross-sectional, non-interventional, single-country format. This research will be conducted as a web-based questionnaire survey. The data obtained in this survey is anonymized, preventing identification of participants.

Management information
Registered date	2019 Year 02 Month 04 Day
Last modified on	2019 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040712