UMIN-CTR Clinical Trial

Basic information
Public title	Study on effectiveness of multiple education / practice programs for community-dwelling older adults
Acronym	Effectiveness of multiple intervention programs for community-dwelling older adults
Scientific Title	Study on effectiveness of multiple education / practice programs for community-dwelling older adults
Scientific Title:Acronym	Effectiveness of multiple intervention programs for community-dwelling older adults
Region	Japan

Condition
Condition	Elderly individuals aged 60 years old or older
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effect of the multiple education / practice programs which is focused on the prevention of frailty for the physical and mental conditions of community-dwelling older adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	frailty index of before and after the intervention
Key secondary outcomes	The Activities of Daily Living(ADL),Oquality of life(QOL),the Geriatric Depression Scale(GDS-15),Apacy, health literacy Survey Questionnaire(J-HLS-EU-Q47),social network, physical functions(gait speed, balance ability, etc),cognitive functions (MMSE, MoCA-J, trail making test, etc.),and the Oral function, before and after the intervention (6-month after).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Participation in the multiple education / practice programs which is focused on the prevention of frailty for 6 months
Interventions/Control_2	Live as usual for 6 months
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All elderly people living in Toyoyama-cho, over 60 years old Those who understand the research content and obtained consent by writing
Key exclusion criteria	Individuals who do not have enough ability to fully agree on research participation Individuals who have received nursing care certification
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Kuzuya
Organization	Nagoya University
Division name	Institute of innovation for future society (Department of community health & geriatrics graduate school of medicine)
Zip code	4668550
Address	65 Tsurumai-cyo, Showa-ku, Nagoya, 466-8550, Japan
TEL	+81527442368
Email	aiaiori@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Aiko Middle name Last name Inoue
Organization	Nagoya University
Division name	Institute of innovation for future society (Department of community health & geriatrics graduate sch
Zip code	466-8550
Address	65 Tsurumai-cyo, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-744-2364
Homepage URL
Email	aiaiori@med.nagoya-u.ac.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	Nagoya University
Address	65 Tsurumai-cyo, Showa-ku, Nagoya, 466-8550, Japan
Tel	052-744-2368
Email	aiaiori@med.nagoya-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	2019 Year 09 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	No longer recruiting
Date of protocol fixation	2019 Year 08 Month 30 Day
Date of IRB	2019 Year 09 Month 17 Day
Anticipated trial start date	2019 Year 09 Month 25 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	2019 Year 07 Month 16 Day
Last modified on	2022 Year 07 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042616