UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058848 |
|---|---|
| Receipt number | R000067290 |
| Scientific Title | A study to verify the effectiveness of a nursing intervention program using digital storytelling for people with alcohol use disorders living in the community |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/20 12:00:05 |
* 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
A study to verify the effectiveness of a nursing intervention program using digital storytelling for people with alcohol use disorders living in the community
Acronym
A study to verify the effectiveness of a nursing intervention program using digital storytelling for people with alcohol use disorders living in the community
Scientific Title
A study to verify the effectiveness of a nursing intervention program using digital storytelling for people with alcohol use disorders living in the community
Scientific Title:Acronym
A study to verify the effectiveness of a nursing intervention program using digital storytelling for people with alcohol use disorders living in the community
Region
| Japan |
Condition
Condition
Alcohol use disorder
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Evaluate the effectiveness of the program by measuring changes in metacognition, self-esteem, self-efficacy, and recovery before and after the intervention.
2. Identify issues and areas for improvement in program implementation based on program appropriateness and satisfaction level evaluations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metacognitions Questionnaire; MCQ-30 :Evaluate before intervention, after intervention and one month after intervention
Key secondary outcomes
Recovery Assessment Scale; RAS :Evaluate before intervention, after intervention and one month after intervention
Rosenberg`s Self Esteem Scale; RSES :Evaluate before intervention, after intervention and one month after intervention
General Self-Efficacy Scale; GSES :Evaluate before intervention, after intervention and one month after intervention
Alcohol Use Disorders Identification Test; AUDIT :Evaluate before intervention, after intervention and one month after intervention
Program appropriateness, satisfaction :Evaluated after intervention
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
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Intervention Details: A nursing intervention program will be conducted using an online conferencing system.
Intervention period: Five weeks
Intervention frequency: Once a week
Number of interventions: Five times
Intervention Duration: One hour per session
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Diagnosed with alcohol use disorder
(2) Living at home
(3) Has been informed about the content of the study and has agreed to participate in the study
(4) Access to a computer and the internet
Key exclusion criteria
Patients who are deemed incapable of giving consent due to dementia or other conditions
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Graduate School of Nursing
Zip code
260-8672
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2434
23nd1006@student.gs.chiba-u.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Graduate School of Nursing
Zip code
260-8672
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2434
Homepage URL
23nd1006@student.gs.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
The Ethics Review Committee, Graduate School of Nursing, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-226-2462
kango-rinri@chiba-u.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 | 08 | Month | 20 | 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 | 08 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | 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
Management information
Registered date
| 2025 | Year | 08 | Month | 20 | Day |
Last modified on
| 2025 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067290
