UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056849 |
|---|---|
| Receipt number | R000064971 |
| Scientific Title | Investigation of the Effect of Self-reported Medication Adherence Tracking Using Common Messaging Applications on Medication Adherence |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2026/02/06 12:10:28 |
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Basic information
Public title
Investigation of the Effect of Self-reported Medication Adherence Tracking Using Common Messaging Applications on Medication Adherence
Acronym
Investigation of the Effect of Self-reported Medication Adherence Tracking Using Common Messaging Applications on Medication Adherence
Scientific Title
Investigation of the Effect of Self-reported Medication Adherence Tracking Using Common Messaging Applications on Medication Adherence
Scientific Title:Acronym
Investigation of the Effect of Self-reported Medication Adherence Tracking Using Common Messaging Applications on Medication Adherence
Region
| Japan |
Condition
Condition
chronic mental illness
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the impact of self-reported medication counting using commercially available messaging applications on medication adherence among outpatients with chronic psychiatric disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement in Medication Adherence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention in this study involves providing a therapeutic application in the form of a LINE-based messaging app to patients with chronic psychiatric disorders who are receiving outpatient pharmacological treatment. This application features an AI chatbot designed to conduct symptom assessments.
The study period extends from the date of research approval until December 31, 2025. Individual patients will use the application continuously from the time of consent until the study end date. The symptom assessment through the AI chatbot can be initiated at any time by the patient sending a message to the chat. Additionally, one message prompting conversation initiation will be sent daily.
It should be noted that routine medical care (including medication regimens and consultation frequency) will remain unchanged, with the application use being the only additional intervention implemented.
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
The study participants include adult patients (aged 18 or older) with chronic psychiatric disorders who are receiving treatment at our hospital and who can fully understand the study protocol and provide consent independently.
Key exclusion criteria
Patients who cannot fully understand the research content and those deemed inappropriate for study participation by the researchers will be excluded. The study participation will also be terminated if a participant withdraws their consent after enrollment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Matsumoto |
Organization
Medical Corporation Kokokara
Division name
Psychiatry
Zip code
6340804
Address
Medical Corporation Kokokara Nara Kokoro to Karada no Clinic M.I. Building 4F, 1-1-44 Naizen-cho, Kashihara City, Nara Prefecture
TEL
0744-47-2100
rmatsumoto@kokokara.or.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Matsumoto |
Organization
Medical Corporation Kokokara
Division name
Psychiatry
Zip code
6340804
Address
Medical Corporation Kokokara Nara Kokoro to Karada no Clinic M.I. Building 4F, 1-1-44 Naizen-cho, Ka
TEL
0744-47-2100
Homepage URL
rmatsumoto@kokokara.or.jp
Sponsor or person
Institute
Medical Corporation Kokokara
Institute
Department
Personal name
Funding Source
Organization
Medical Corporation Kokokara
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Kokokara
Address
Medical Corporation Kokokara Nara Kokoro to Karada no Clinic M.I. Building 4F, 1-1-44 Naizen-cho, Kashihara City, Nara Prefecture
Tel
0744-47-2100
rmatsumoto@kokokara.or.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
| 2025 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064971
