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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036495
Receipt No. 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 2021/04/14

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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
Email 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
Email mihirano@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041511

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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