UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045808 |
|---|---|
| Receipt number | R000052271 |
| Scientific Title | Doctor's current practice and perspectives on delivering bad news in ALS. : an international survey in Asian and Oceanian countries. |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2025/05/07 11:47:39 |
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Basic information
Public title
Doctor's current practice and perspectives on delivering bad news in ALS. : an international survey in Asian and Oceanian countries.
Acronym
Doctor's current practice and perspectives on delivering bad news in ALS. : an international survey in Asian and Oceanian countries.
Scientific Title
Doctor's current practice and perspectives on delivering bad news in ALS. : an international survey in Asian and Oceanian countries.
Scientific Title:Acronym
Doctor's current practice and perspectives on delivering bad news in ALS. : an international survey in Asian and Oceanian countries.
Region
| Japan | Asia(except Japan) | Australia |
Condition
Condition
Amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine the current practice and the tasks of neurologists in breaking the news of an ALS diagnosis in Asian and Oceanian countries.
Basic objectives2
Others
Basic objectives -Others
Assess the neurologists' educational and training needs related to breaking bad news.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
(a)Representative value and distributions of the question items composed according to international guideline for delivering diagnosis in ALS.
Key secondary outcomes
Representative value, distributions, and group differences of items related following aspects.
(b)Profile of neurologists.
(c)Current practice of treating ALS cases.
(d)The neurologists' educational and training needs related to breaking ALS diagnosis.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Doctors who apply all following criterion:
(a)are / have been working in Asian or Oceanian countries as doctors.
(b)have ever experienced delivering ALS diagnosis.
(c)consent to participate to this study.
Key exclusion criteria
(c)Those who do not apply all of the key inclusion criterion.
(d)Those who were judged as not appropriate participants.
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Kazumoto |
| Middle name | |
| Last name | Shibuya |
Organization
Chiba university hospital
Division name
Department of Neurology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi
TEL
432262738
ojou19900117@gmail.com
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Yoshitake |
Organization
National
Division name
Integrative Brain Imaging Center
Zip code
042-341-2711
Address
4 Chome-1-1 Ogawahigashicho, Kodaira, Tokyo 187-8551
TEL
042-341-2711
Homepage URL
https://www.m.chiba-u.ac.jp/dept/neurol/
ojou19900117@gmail.com
Sponsor or person
Institute
Department of neurology,Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The university of Sydney
Name of secondary funder(s)
Ministry of Health, Labour Standards
IRB Contact (For public release)
Organization
Chiba university Graduate School of Medicine
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi
Tel
043-226-2496
inohana-kyodo@chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
M10059
Org. issuing International ID_1
Chiba university Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
424
Results
474 answers were collected from doctors in Asian and Oceanian countriesvalid response rate=67.3%, Male=273, Average years of clinical experience=18.2 SD=10.8) . Multiple regression analysis showed that the level of the Health Care and Access Quality Index independently associated with the achievement level of guideline areas of the time and place, providing information on the latest treatments, ventilators, life-prolonging treatments (p < .05).
Results date posted
| 2025 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Difficulty when delivering the diagnosis of ALS, the stress, clinical experience of ALS, religions, Health care access quality index
Plan to share IPD
None
IPD sharing Plan description
Not applicable
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Online questionnaire survey will be conducted.The questionnaire will be advertised in Pan-Asian Consortium for Treatment and Research in ALS:PACTALS mainly via e-mail etc.
Management information
Registered date
| 2021 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052271
