UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060920 |
|---|---|
| Receipt number | R000069720 |
| Scientific Title | A Prospective Single-Arm Interventional Study Evaluating the Impact of a Video-Based Educational Tool on Attitudes Toward Long-Acting Injectable Antipsychotics in Patients With Schizophrenia |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/17 21:43:44 |
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Basic information
Public title
Impact of a Video-Based Educational Tool on Attitudes Toward Long-Acting Injectable Antipsychotics in Patients With Schizophrenia: A Prospective Interventional Study
Acronym
LAI-VIDEO Study
Scientific Title
A Prospective Single-Arm Interventional Study Evaluating the Impact of a Video-Based Educational Tool on Attitudes Toward Long-Acting Injectable Antipsychotics in Patients With Schizophrenia
Scientific Title:Acronym
LAI-VIDEO
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether viewing a video-based educational tool explaining long-acting injectable antipsychotics (LAIs) influences willingness to initiate LAI treatment among patients with schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the NRS score for willingness to try LAI treatment if recommended by a physician (Q4), assessed before video viewing, after video (I), and after video (II).
Key secondary outcomes
As secondary outcomes, the associations between willingness to initiate LAI treatment assessed by a Numerical Rating Scale (NRS) and Ten Item Personality Inventory Japanese version (TIPI-J) scores, Positive and Negative Syndrome Scale scores, age, sex, and duration of illness will be examined.
In addition, changes in the NRS scores for three questionnaire items will be examined across three time points: before video viewing, after viewing video (I), and after viewing video (II). The items are (Q1) "LAI treatment is effective in preventing relapse", (Q2) "Receiving LAI treatment is expected to stabilize daily life", and (Q3) "I feel reassured about receiving intramuscular injections".
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
| Behavior,custom |
Interventions/Control_1
In this study, participants will receive an educational video intervention about long acting injectable antipsychotics (LAI). The video lasts approximately 5 minutes and consists of two sections.
Video (I) explains the effectiveness of antipsychotic medications for schizophrenia, the importance of medication adherence, the available formulations of antipsychotics, the potential role of LAI treatment in preventing relapse, and the possibility of injection related pain as a specific adverse effect of LAI treatment.
Video (II) explains that injection site pain associated with LAI administration may be reduced by using a cooling pack before the injection.
Participants will complete questionnaires at three time points: before video viewing, after viewing video (I), and after viewing video (II).
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age 18 years or older
Diagnosis of schizophrenia
Outpatients receiving treatment at Aichi Medical University Hospital, Kasadera Seichiryo Hospital, or Shoin Hospital
Key exclusion criteria
Visual or hearing impairment that makes it difficult to watch the educational video or complete the questionnaire
Previous treatment with long acting injectable antipsychotics (LAIs)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University
Division name
Neuropsychiatric Department
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
fujita.kouhei.077@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University
Division name
Neuropsychiatric Department
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
fujita.kouhei.077@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical 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
Research Support Division, Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan
Tel
0561-62-3311
kenshi@aichi-med-u.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
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069720
