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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035769
Receipt No. R000040712
Official scientific title of the study Questionnaire survey for perspectives of patients and doctors on diagnosis and treatment in Parkinson's disease; PD voice study
Date of disclosure of the study information 2019/02/10
Last modified on 2019/02/12

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Basic information
Official scientific title of the study Questionnaire survey for perspectives of patients and doctors on diagnosis and treatment in Parkinson's disease; PD voice study
Title of the study (Brief title) 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
Name of lead principal investigator Masahiro Nomoto
Organization The Social Welfare Organization Imperial Gift Foundation Inc,
Saiseikai Imabari Center for Health and Welfare
Division name Department of Neurology
Address 7-6-1 Kitamura, Imabari, Ehime
TEL 0898-47-2500
Email m-nomoto@imabari.saiseikai.or.jp

Public contact
Name of contact person Takayuki Ishida
Organization Takeda Pharmaceutical Company Limited
Division name Japan Medical Affairs
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 02 Month 01 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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 02 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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