UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053477 |
|---|---|
| Receipt number | R000060143 |
| Scientific Title | Effects of Smart Senior Program for anxiety among the elderly |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2025/01/30 09:04:40 |
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Basic information
Public title
Effects of Smart Senior Program among the elderly
Acronym
Effects of Smart Senior Program
Scientific Title
Effects of Smart Senior Program for anxiety among the elderly
Scientific Title:Acronym
Effects of Smart Senior Program
Region
| Japan |
Condition
Condition
The elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal that the course relieve the elderly of anxiety of the future
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
anxiety of the future
State-Trait Anxiety Inventory
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Courses about health, economy, and disaster for the elderly
Interventions/Control_2
Take the course after all measurements are completed
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years of age or older
Able to communicate in language
High anxiety scale score
Key exclusion criteria
Receiving nursing care or support
Having a serious mental disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Fukase |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
Kitazato 1-15-1, Minami-ku, Sagamihara, JAPAN
TEL
0427788031
fukase@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Fukase |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
Kitazato 1-15-1, Minami-ku, Sagamihara, JAPAN
TEL
0427788031
Homepage URL
fukase@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI and Kitasato University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Allied Health Sciences institutional review board
Address
Kitazato 1-15-1, Minami-ku, Sagamihara, JAPAN
Tel
042-778-8896
a-soumu@kitasato-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
| 2024 | Year | 01 | Month | 31 | 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
34
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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060143
