UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042330
Receipt number R000048318
Scientific Title Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care
Date of disclosure of the study information 2020/11/02
Last modified on 2023/03/07 10:23:43

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Basic information

Public title

Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care

Acronym

Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care

Scientific Title

Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care

Scientific Title:Acronym

Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care

Region

Japan


Condition

Condition

Deterioration of living function, depression, social isolation,loneliness

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the extent to which behavioral changes, such as social participation, will occur by creating communities that encourage people to participate using IoT and other technologies, and to estimate the extent to which these changes will improve health (intermediate) outcomes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

depression

Key secondary outcomes

Self-rated health, instrumental activities of daily living, physical function (locomotive function, history of fall etc), psychological function (happiness etc), social function (including inside and outside the internet social network, social support, social participation etc), oral function, sleep condition, eating habits, cognitive function, risk assessment scales for needed long-term care, frail, status of ICT use, number of steps, frequency of going out , social isolation,loneliness etc.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Locations using IoT and PHR(21 hours per 3 weeks , 3 Cool)

Interventions/Control_2

Locations without using IoT and PHR

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

Community-dwelling older adults (living in municipalities of Japan listed as follows: Matsudo, Sakai)

Key exclusion criteria

Needed Long-Term Care , Loss of independence in activities of daily living

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Katsunori
Middle name
Last name Kondo

Organization

Chiba University/National Center for Geriatrics and Gerontology

Division name

Center for Preventive Medical Sciences/Center for Gerontology and Social Science

Zip code

263-8522/474-8511

Address

1-33 Yayoicho, Inage Ward, Chiba City, Chiba Prefecture 263-8522 Japan/7-430 Morioka-ch o, Obu City, Aichi Prefecture 474-8511 Japan

TEL

043-290-3177

Email

umin-ctr@jages.net


Public contact

Name of contact person

1st name Katsunori
Middle name
Last name Kondo

Organization

Chiba University

Division name

Center for Preventive Medical Sciences/Center for Gerontology and Social Science

Zip code

263-8522

Address

1-33 Yayoicho, Inage Ward, Chiba City, Chiba Prefecture 263-8522 Japan

TEL

043-290-3177

Homepage URL


Email

umin-ctr@jages.net


Sponsor or person

Institute

Chiba University, National Center for Geriatrics and Gerontology

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Center for Geriatrics and Gerontology, Matsudo City, Sakai City

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research ethics committee of the graduate school of medicine, Chiba university

Address

1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefect ure 260-8670 Japan

Tel

043-226-2501

Email

igaku-rinri@office.chiba-u.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 11 Month 02 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

Open public recruiting

Date of protocol fixation

2020 Year 11 Month 05 Day

Date of IRB

2020 Year 09 Month 15 Day

Anticipated trial start date

2020 Year 11 Month 13 Day

Last follow-up date

2024 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

2020 Year 11 Month 02 Day

Last modified on

2023 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name