UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056129 |
|---|---|
| Receipt number | R000064134 |
| Scientific Title | An intervention study to assess efficiency of a new asthma control questionnaire for elderly asthma |
| Date of disclosure of the study information | 2024/11/12 |
| Last modified on | 2024/11/12 14:05:27 |
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Basic information
Public title
An intervention study to assess efficiency of a new asthma control questionnaire for elderly asthma
Acronym
efficiency of a new asthma control questionnaire for elderly asthma
Scientific Title
An intervention study to assess efficiency of a new asthma control questionnaire for elderly asthma
Scientific Title:Acronym
efficiency of a new asthma control questionnaire for elderly asthma
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the validity and usefulness of a newly developed asthma questionnaire for the elderly in daily clinical practice, and to assess life functions, including physical activity and cognitive function, in elderly asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Asthma-related quality of life (AQLQ) before and after use of the new questionnaire
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
new questionnaire
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients shall meet all of the following criteria.
(1) Asthmatic patients aged 65 years or older who have been attending the study institution for at least one year
(2) Patients on GINA treatment steps 3, 4 and 5 at the time of enrolment
(3) Patients with information on treatment/medication in the last year prior to enrolment
(4) Patients with information on the number of acute asthma exacerbations, hospital admissions for asthma and unscheduled visits for asthma in the last year prior to registration
(5) Patients who have given their free written consent.
Key exclusion criteria
Patients who fall into any of the following categories shall not be included in the study.
(1) Patients with chronic respiratory diseases other than asthma/COPD
(2) Patients with a history of surgery/disease that would affect the physiological function tests
(3) Patients with psychiatric/neurological disorders or physical dysfunctions that may affect the questionnaire
(4) Other patients deemed inappropriate by the principal investigator/contributor.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
2048585
Address
3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan
TEL
+81-42-491-2111
fueta-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
2048585
Address
3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan
TEL
+81-42-491-2111
Homepage URL
fueta-tky@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency of Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organisation Nagoya Medical Center
Address
4-1-1, Sanomaru, Naka-ku, Nagoya, Aichi, Japan
Tel
+81-52-951-1111
311-rec@mail.hosp.go.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
| 2024 | Year | 11 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064134
