UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effectiveness of information technology-based health promotion programs for community dwelling older adults
Acronym	The effectiveness of information technology-based health promotion programs
Scientific Title	Study on the effectiveness of information technology-based health promotion programs for community dwelling older adults
Scientific Title:Acronym	The effectiveness of information technology-based health promotion programs
Region	Japan

Condition
Condition	older adults
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of a tablet-based education program about geriatric syndrome on the health and mental status of community-dwelling older adults, and to compare the effects with those of conventional projects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Health consciousness of before and after the intervention.
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),the Lubben Social Network Scale, ICT usage status, the cognitive functions (MoCA-J, trail making test, etc), nutritional status.

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Received 4 months of IT-based health education and no intervention after 1 month of wash out period.
Interventions/Control_2	After a one-month wash-out period without intervention for four months, receive four months of IT-based health education.
Interventions/Control_3	Participate in face-to-face health classes in addition to traditional health classes.
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 older adults living in Minamichita-cho, over 65 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	150

Research contact person
Name of lead principal investigator	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 school of medicine)
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-744-2368
Email	chiharu83724@coi.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Chiharu Middle name Last name Uno
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-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-744-2368
Homepage URL
Email	chiharu83724@coi.nagoya-u.ac.jp

Sponsor
Institute	Nagoya university Institute of innovation for future society (Department of community health & geriatrics graduate school of medicine)
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	Minamichita-cho, Chita-gun, Aichi Prefecture, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Etics Committee of the Nagoya University Graduate School of Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
Tel	052-744-2973
Email	ethics@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	2021 Year 06 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	110
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	2021 Year 05 Month 20 Day
Date of IRB	2021 Year 05 Month 28 Day
Anticipated trial start date	2021 Year 06 Month 01 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	2021 Year 04 Month 25 Day
Last modified on	2022 Year 11 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050159