UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of an inhalation instruction support system for inhalation therapy
Title of the study (Brief title)	Development of an inhalation instruction support system
Region	Japan

Condition
Condition	Bronchial asthma Chronic obstructive pulmonary disease(COPD)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We find that inhalation instruction using a tablet terminal reduces the burden on medical staff or acquires inhalation techniques in a patient.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time required for medication instruction(first time, 1 month, 2 months, 3 months later).
Key secondary outcomes	1) Peak flow rate 2) Pulmonary function test 3) Asthma control test(ACT) 4) COPD assessment test(CAT) 5) Evaluation of inhalation techniques (first time, 1 month, 2 months, 3 months later)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Use a tablet terminal for medication instruction. The patient will see a video of the inhalation techniques in the waiting time at the pharmacy and do not demonstrate the pharmacist with the first instruction. The frequency of intervention is once a month and the period is three months per case. The type of inhalation medicine and the dosage regimen will be in accordance with what was decided by usual clinical practice.
Interventions/Control_2	Do not use tablet terminals for medication instruction. The patient does nothing at the waiting time at the pharmacy, and he does the same medication instruction as before (the pharmacist performs a demonstration). The frequency of intervention is once a month and the period is three months per case. The type of inhalation medicine and the dosage regimen will be in accordance with what was decided by usual clinical practice.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients diagnosed with bronchial asthma or COPD. 2) Patients prescribed new or modified inhalation medications. 3) Outpatient 4) Patients unnecessary to change pharmacies when receiving prescription medication.
Key exclusion criteria	1) Patients who can not use tablets. 2) Patients judged inappropriate for judgment by doctor's judgment.
Target sample size	36

Research contact person
Name of lead principal investigator	Kunio Dobasi
Organization	Gunma University Graduate School
Division name	Health Sciences
Address	3-39-22 Showa-machi, Maebashi, Gunma, 371-8511 Japan
TEL	027-220-8132
Email	dobashik@gunma-u.ac.jp

Public contact
Name of contact person	Kunio Dobashi
Organization	Gunma University Hospital
Division name	Department of Respiratory and Allergy
Address	3-39-15 Showa-machi, Maebashi, Gunma, 371-8511 Japan
TEL	027-220-8132
Homepage URL
Email	dobashik@gunma-u.ac.jp

Sponsor
Institute	Gunma Society of Inhalation Therapy
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	群馬大学医学部附属病院（群馬県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 05 Month 05 Day
Anticipated trial start date	2017 Year 05 Month 08 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 05 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031214