Tokyo, Feb. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060546) titled 'Evaluation of the Effectiveness and Efficiency of Inhalation Instruction Videos' on Feb. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - TOYOTA REGIONAL MEDICAL CENTER
Condition:
Condition - bronchial asthma,Chronic obstructive pulmonary disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - video viewing
Interventions/Control_2 - no video viewing
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 Size - 30
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069249
Disclaimer: Curated by HT Syndication.
