UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035053 |
|---|---|
| Receipt number | R000039964 |
| Scientific Title | Study to promote employment and enrollment support of patients with bronchial asthma and their carers |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2024/12/02 12:42:12 |
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Basic information
Public title
Study to promote employment and enrollment support of patients with bronchial asthma and their carers
Acronym
Research on employment and school attendance of family members of asthma patients
Scientific Title
Study to promote employment and enrollment support of patients with bronchial asthma and their carers
Scientific Title:Acronym
Research on employment and school attendance of family members of asthma patients
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is to investigate the current situation of bronchial asthma on the employment and enrollment of patients and caregivers, to propose and disseminate its support system.
Basic objectives2
Others
Basic objectives -Others
Preparation of support manuals for patients / caregivers, workplaces, schools
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survey on difficult situation on employment and enrollment in patients with bronchial asthma.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Questionnaire survey
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. A patient whose principal or his / her family is diagnosed with bronchial asthma.
2. Patient who can answer questionnaire survey.
3 Patients over the age of 15.
4. Patient who got consent of the person concerned about participation in research.
Key exclusion criteria
1. Patients who are unable to obtain written informed consent for participation in this study.
2. Patient who can not respond to questionnaire due to dementia.
3. Patient judged to be inapplicable by research doctor.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Takayama |
Organization
Kyoto Prefectural University of Medicine
Division name
respiratory medecine
Zip code
602-8566
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL
075-251-5513
kaneko-y@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Kaneko |
Organization
Kyoto Prefectural University of Medicine
Division name
respiratory medecine
Zip code
602-8566
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL
075-251-5513
Homepage URL
kaneko-y@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
Tel
075-251-5337
rinri@koto.kpu-m.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://kpu.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=2914
Publication of results
Unpublished
Result
URL related to results and publications
https://kpu.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=2914
Number of participants that the trial has enrolled
113
Results
Approximately 10% of employed patients had a history of taking breaks, arriving late, or leaving early due to poor health caused by asthma within the past week. The rate of absenteeism and work restrictions due to illness were related to the disease control status, and improving disease control was considered to be the top priority in balancing illness and work.
Results date posted
| 2024 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A survey was conducted on 113 adult asthma patients and their caregivers who were visiting hospitals and clinics in each region, and the results were analyzed. Approximately 10% of employed patients had a history of taking breaks, arriving late, or leaving early due to poor health caused by asthma within the past week. The rate of absenteeism and work restrictions due to illness were related to the disease control status, and improving disease control was considered to be the top priority in balancing illness and work.
Participant flow
A survey was conducted on 113 adult asthma patients and their caregivers who were visiting hospitals and clinics in each region, and the results were analyzed. Approximately 10% of employed patients had a history of taking breaks, arriving late, or leaving early due to poor health caused by asthma within the past week. The rate of absenteeism and work restrictions due to illness were related to the disease control status, and improving disease control was considered to be the top priority in balancing illness and work.
Adverse events
non
Outcome measures
A survey was conducted on 113 adult asthma patients and their caregivers who were visiting hospitals and clinics in each region, and the results were analyzed. Approximately 10% of employed patients had a history of taking breaks, arriving late, or leaving early due to poor health caused by asthma within the past week. The rate of absenteeism and work restrictions due to illness were related to the disease control status, and improving disease control was considered to be the top priority in balancing illness and work.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039964
