UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055536 |
|---|---|
| Receipt number | R000063469 |
| Scientific Title | Evaluation of Treatment Adherence Using a Mobile Application for Asthma Self-Management Support: An Exploratory Study |
| Date of disclosure of the study information | 2024/09/19 |
| Last modified on | 2024/09/18 22:46:30 |
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Basic information
Public title
Evaluation of Treatment Adherence Using a Mobile Application for Asthma Self-Management Support: An Exploratory Study
Acronym
Evaluation of Treatment Adherence Using a Mobile Application for Asthma Self-Management Support
Scientific Title
Evaluation of Treatment Adherence Using a Mobile Application for Asthma Self-Management Support: An Exploratory Study
Scientific Title:Acronym
Evaluation of Treatment Adherence Using a Mobile Application for Asthma Self-Management Support
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the impact of short-term implementation of support via a mobile application on treatment adherence in patients with asthma, and to explore the relationship between treatment adherence and both asthma control status and quality of life (QOL).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ASK-12
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Individuals aged 18 or older at the time of consent acquisition.
2.Individuals with experience using a smartphone.
3.Individuals who have experienced a shortage of prescribed inhaled medications necessary for the interval between medical visits.
4.Individuals within two months of their initial consultation.
5.Individuals who have experienced asthma-related symptoms (such as increased sputum production or shortness of breath during walking) within the past six months.
6.Individuals who have had an asthma attack within the past six months.
7.Individuals who have demonstrated airflow obstruction on spirometry or expiratory flow limitation in the flow-volume curve within the past six months.
8.Individuals who, after receiving a thorough explanation regarding participation in this study, have provided written informed consent of their own free will, having fully understood the study's details.
Individuals who meet all of the inclusion criteria 1, 2, and 8, and also meet any of the criteria from 3 to 7.
Key exclusion criteria
1.Individuals who have received asthma-related self-management education or rehabilitation within the past six months.
2.Individuals who have experienced an exacerbation within the past month.
3.Individuals with comorbid chronic respiratory diseases such as COPD or interstitial pneumonia.
4.Individuals with comorbid conditions such as chronic heart failure or unstable hypertension.
5.Individuals with comorbid dementia.
6.Individuals with visual or field of vision impairments that make it difficult to identify a smartphone screen.
7.Individuals otherwise deemed ineligible by the study investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Ueki |
Organization
Juntendo University Graduate School of Health Care and Nursing
Division name
Clinical Research Unit of Respiratory Pathophysiology
Zip code
279-0023
Address
2-5-1, Takasu, Urayasu City, Chiba
TEL
0473553111
junueki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Ueki |
Organization
Juntendo University Graduate School of Health Care and Nursing
Division name
Clinical Research Unit of Respiratory Pathophysiology
Zip code
279-0023
Address
2-5-1, Takasu, Urayasu City, Chiba
TEL
0473553111
Homepage URL
junueki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1 Hongo Bunkyo-ku Tokyo
Tel
0338133111
junueki@juntendo.ac.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
| 2024 | Year | 09 | Month | 19 | 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
| 2024 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Following consent, self-management support using a mobile application installed on a smartphone will be implemented for a period of three months. The study will examine the impact of this support on treatment adherence, as well as the relationship between treatment adherence and both asthma control status and quality of life (QOL).
Management information
Registered date
| 2024 | Year | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063469
