UMIN-CTR Clinical Trial

Basic information
Public title	The effect of community disaster prevention activities on the connection of older people and the prevention of isolation
Acronym	The effect of community disaster prevention activities on the connection of older people and the prevention of isolation
Scientific Title	The effect of community disaster prevention activities on the connection of older people and the prevention of isolation
Scientific Title:Acronym	The effect of community disaster prevention activities on the connection of older people and the prevention of isolation
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Nursing Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to implement the community disaster prevention activities and to clarify the following effects; Efforts to relationship between older people and prevent isolation in preparation for disasters.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Social support for subjects 1 month after intervention
Key secondary outcomes	Efforts to prevent isolation in preparation for disasters 1 month after intervention

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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	disaster prevention education
Interventions/Control_2	No intervention
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	Older people who don't need assistance in activities of daily living
Key exclusion criteria	People who do not agree to participate in the study
Target sample size	60

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	060-0812
Address	Japan. N12W5, Kita-ku, Sapporo
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	060-0812
Address	Japan. N12W5, Kita-ku, Sapporo
TEL	011-706-3377
Homepage URL
Email	mihirano@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Hokkaido 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	the Ethics Committee of Hokkaido University Faculty of Health Sciences
Address	Japan. N12W5, Kita-ku, Sapporo
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	2022 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	Main results already published
Date of protocol fixation	2020 Year 02 Month 01 Day
Date of IRB	2020 Year 03 Month 10 Day
Anticipated trial start date	2020 Year 03 Month 10 Day
Last follow-up date	2021 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	2020 Year 02 Month 01 Day
Last modified on	2022 Year 04 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044881