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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033474
Receipt No. R000038060
Scientific Title Study on effectiveness verification of promotion programs of health behavior utilizing broadcast media for community-dwelling elderly
Date of disclosure of the study information 2018/08/01
Last modified on 2018/07/30

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Basic information
Public title Study on effectiveness verification of promotion programs of health behavior utilizing broadcast media for community-dwelling elderly
Acronym Effectiveness verification of promotion programs of health behavior utilizing broadcast media
Scientific Title Study on effectiveness verification of promotion programs of health behavior utilizing broadcast media for community-dwelling elderly
Scientific Title:Acronym Effectiveness verification of promotion programs of health behavior utilizing broadcast media
Region
Japan

Condition
Condition Elderly individuals aged 65 years old or older
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of the promotion program of health behavior utilizing broadcast media for prevention of frailty and cognitive decline on health consciousness and action in community-dwelling elderly
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Health consciousness for 4 months
Key secondary outcomes The Activities of Daily Living (ADL), quality of life (QOL),the Geriatric Depression Scale (GDS-15), health literacy Survey Questionnaire(J-HLS-EU-Q47), physical functions(gait speed, balance ability, etc) and the cognitive functions (MoCA-J, trail making test, etc.) , before and after the intervention (4-month after).

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 Prevention
Type of intervention
Other
Interventions/Control_1 Broadcasting (cable TV) of promotion programs of health behavior for 4 months.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All elderly people living in Toyoyama-cho, over 65 years old

Those who understand the research content and obtained consent by writing
Key exclusion criteria Persons who do not have enough ability to fully agree on research participation
Persons who have received nursing care certification (nursing care 1 to 5 required)
Target sample size 2575

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Kuzuya
Organization Nagoya University
Division name Institute of innovation for future society (Department of community health & geriatrics graduate school of medicine)
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, japan
TEL 052-744-2364
Email kuzuya@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aiko Inoue
Organization Nagoya University
Division name Institute of innovation for future society (Department of community health & geriatrics graduate sch
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, japan
TEL 052-744-2364
Homepage URL
Email aiaiori@med.nagoya-ua.c.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Japan science and technology agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Toyoyama-cho, Nishikasugai-gun, Aichi Prefecture, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 08 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 23 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038060

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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