UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035769 |
|---|---|
| Receipt number | R000040712 |
| Scientific Title | 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 | 2019/05/15 15:00:11 |
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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
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
m-nomoto@imabari.saiseikai.or.jp
Public contact
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
takayuki.ishida@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company, Limited
Japan Medical Affairs
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040712
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
