UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035105
Receipt number R000040015
Scientific Title A Study on ICT Utilization in the Life of Older Men
Date of disclosure of the study information 2020/02/01
Last modified on 2022/04/19 09:01:35

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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 or person

Institute

Hokkaido University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040015


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name