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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027249
Receipt No. R000031214
Scientific Title Development of an inhalation instruction support system for inhalation therapy
Date of disclosure of the study information 2017/05/08
Last modified on 2018/05/31

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Basic information
Public title Development of an inhalation instruction support system for inhalation therapy
Acronym Development of an inhalation instruction support system
Scientific Title Development of an inhalation instruction support system for inhalation therapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Kunio Dobasi
Organization Gunma University Graduate School
Division name Health Sciences
Zip code
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
1st name
Middle name
Last name Kunio Dobashi
Organization Gunma University Hospital
Division name Department of Respiratory and Allergy
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000031214

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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