UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036495 |
|---|---|
| Receipt number | R000041511 |
| Scientific Title | Development of a social activity program using ICT to prevent flail in rural |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2022/04/19 09:02:08 |
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Basic information
Public title
Development of a social activity program using ICT to prevent flail in rural
Acronym
Development of a social activity program using ICT to prevent flail in rural
Scientific Title
Development of a social activity program using ICT to prevent flail in rural
Scientific Title:Acronym
Development of a social activity program using ICT to prevent flail in rural
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to implement and test the effects of a social activity program for flail prevention among older adults living in rural areas using a collective social activity program and an interaction app.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Social flail evaluation items
Key secondary outcomes
Physical fare evaluation items
Psychological flare evaluation items
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
1. Implementation of social activity programs in monthly group activities
2. Use of a smartphone with an interaction app downloaded
Interventions/Control_2
Observation only
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Participants in community-based group activities for older
2. Obtained consent to participate in the study
Key exclusion criteria
Persons receiving outpatient treatment for dementia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Hirano |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
N12W5, Kita-ku, Sapporo 060-0812, Japan
TEL
011-706-3377
mihirano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Hirano |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
060812
Address
N12W5, Kita-ku, Sapporo 060-0812, Japan
TEL
011-706-3377
Homepage URL
mihirano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
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
Hokkaido University Ethics Committee
Address
N12W5, Kita-ku, Sapporo 060-0812, Japan
Tel
011-706-3316
shomu@hs.hokudai.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
| 2020 | Year | 12 | 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
19
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
| 2019 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 04 | Month | 13 | Day |
Last modified on
| 2022 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041511
