UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027249 |
|---|---|
| Receipt number | 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 19:28:31 |
* 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
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
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
dobashik@gunma-u.ac.jp
Sponsor or person
Institute
Gunma Society of Inhalation Therapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031214
