UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060546 |
|---|---|
| Receipt number | R000069249 |
| Scientific Title | Evaluation of the Effectiveness and Efficiency of Inhalation Instruction Videos |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/02/01 20:36:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the Effectiveness and Efficiency of Inhalation Instruction Videos
Acronym
Evaluation of the Effectiveness and Efficiency of Inhalation Instruction Videos
Scientific Title
Evaluation of the Effectiveness and Efficiency of Inhalation Instruction Videos
Scientific Title:Acronym
Evaluation of the Effectiveness and Efficiency of Inhalation Instruction Videos
Region
| Japan |
Condition
Condition
bronchial asthma,Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inhaled medications constitute the first-line therapy for bronchial asthma and chronic obstructive pulmonary disease (COPD). Unlike oral pharmacologic agents, inhaled drugs fail to achieve their intended therapeutic effects unless patients perform the inhalation procedure correctly. To ensure comprehensive and accurate patient education, instructional videos have been developed and made publicly available for each type of inhaler device.
The objective of this clinical study is to evaluate whether viewing these instructional videos enables patients to acquire inhalation techniques with greater accuracy and efficiency. Patients who are using an inhaler for the first time will be randomized into two groups one with access to the instructional video and one without and the time required for inhalation technique instruction as well as the level of comprehension will be compared between the groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total time required for instruction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
video viewing
Interventions/Control_2
no video viewing
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients who have received sufficient explanation about this study and have provided written informed consent based on adequate understanding and of their own free will
2 Patients diagnosed with bronchial asthma or COPD according to established diagnostic criteria
3Patients who are using the specified inhalation device for the first time
4 Patients who are 20 years of age or older at the time of consent
Key exclusion criteria
1 Patients with tuberculosis-related diseases or respiratory infections who are deemed unsuitable for participation in the study by the investigator
2 Patients with a history of severe asthma exacerbation within the past three months
3 Patients with infections for which no effective antimicrobial agents exist, those suspected of having latent fungal infections, or those with non-respiratory infections who are deemed unsuitable for participation in the study by the investigator
4 Patients with poorly controlled diabetes, hypertension, heart disease, or hyperthyroidism who are deemed unsuitable for participation in the study by the investigator
5 Any other patients judged to be inappropriate for participation by the principal investigator or sub-investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Horiguchi |
Organization
TOYOTA REGIONAL MEDICAL CENTER
Division name
Respiratory internal medicine
Zip code
471-0062
Address
3-30-1 Nishiyama-cho,Toyota City,Aichi Prefecture,Japan
TEL
0565-34-3000
ta-hori@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Kato |
Organization
TOYOTA REGIONAL MEDICAL CENTER
Division name
Respiratory internal medicine
Zip code
471-0062
Address
3-30-1 Nishiyama-cho,Toyota City,Aichi Prefecture,Japan
TEL
0565-34-3000
Homepage URL
kenichi.kato@toyotachiiki-mc.or.jp
Sponsor or person
Institute
TOYOTA REGIONAL MEDICAL CENTER
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TOYOTA REGIONAL MEDICAL CENTER
Address
3-30-1 Nishiyama-cho,Toyota City,Aichi Prefecture,Japan
Tel
0565-34-3000
kenichi.kato@toyotachiiki-mc.or.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
| 2026 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 01 | Day |
Last modified on
| 2026 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069249
