UMIN-CTR Clinical Trial

Basic information
Public title	A Study on ICT Utilization in the Life of Older Men
Acronym	A Study on ICT Utilization in the Life of Older Men
Scientific Title	A Study on ICT Utilization in the Life of Older Men
Scientific Title:Acronym	A Study on ICT Utilization in the Life of Older Men
Region	Japan

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

Objectives
Narrative objectives1	In the basic research on ICT for the senior generation, we clarified the needs of ICT of the older. We developed an app that enables older people to use ICT and interact with friends in a simple and timely manner (Interaction app). The interaction app is a tool to communicate through pedometers and photographs among friends. The aim of this study is to clarify the actual status of the interaction app and ICT use among older men and their effects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is the actual use of the interaction app, and an evaluation is 2 months after the start of the intervention. Outcome is as follows. Time of interaction app, number of posts, and number of replications
Key secondary outcomes

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	Lease smartphones with the interaction app downloaded to all participants for two months. Then, the utilization is requested. Data collection involve questionnaire surveys before and after the intervention, as well as interview surveys after the intervention. Actual usage of the interaction app is logged for each participants in the application server.
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
Key inclusion criteria	Inclusion criteria are as follows. 1. Participants in community-based group activities for older 2. Obtained consent to participate in the study
Key exclusion criteria	Exclusion criteria are as follows. 1. Persons receiving outpatient treatment for dementia
Target sample size	15

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	0600812
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	the ethical committee of the Faculty of Health Sciences, Hokkaido University
Address	N12W5, Kita-ku, Sapporo 060-0812, Japan
Tel	0117063316
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 02 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	2019 Year 01 Month 20 Day
Date of IRB	2019 Year 03 Month 26 Day
Anticipated trial start date	2019 Year 02 Month 10 Day
Last follow-up date	2020 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	2018 Year 12 Month 02 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=R000040015