UMIN-CTR Clinical Trial

Basic information
Public title	The Impact of a Short-Term Online Multidisciplinary Intervention on Improving the Life Challenges of Elderly People Living in the Community
Acronym	The Impact of a Short-Term Online Multidisciplinary Intervention on Improving the Life Challenges of Elderly People Living in the Community
Scientific Title	The Impact of a Short-Term Online Multidisciplinary Intervention on Improving the Life Challenges of Elderly People Living in the Community
Scientific Title:Acronym	The Impact of a Short-Term Online Multidisciplinary Intervention on Improving the Life Challenges of Elderly People Living in the Community
Region	Japan

Condition
Condition	Elderly people living in the community
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine, for care support specialists, etc. engaged in home support, whether responding online using ICT to the life issues of users (elderly people living in the community) who have been consulted by care support specialists, etc. to occupational therapists leads to improvement of the users' life issues compared to the situation before the intervention.
Basic objectives2	Others
Basic objectives -Others	To verify the effectiveness of multidisciplinary cooperation in improving life issues
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Goal Attainment Scale
Key secondary outcomes	Japan Cardiovascular Health Study Aid for decision making of occupation choice pedometer

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom Other
Interventions/Control_1	For care support specialists, etc. engaged in in-home support, respond online using ICT to the lifestyle issues of users (elderly people living in the community) who have consulted with occupational therapists from care support specialists, etc.Each advisory session will last 15 to 20 minutes and will be conducted approximately three times during the first two to seven weeks of the study.
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 and Female
Key inclusion criteria	Those who need support 1 or 2 and those who are eligible for the project Those who have daily life issues that they would like to improve (e.g., shopping, cooking more easily, etc.)
Key exclusion criteria	Those who are currently receiving interventions by occupational therapists other than those in this study
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Taihei Middle name Last name Sakamoto
Organization	Tokyo Metropolitan University
Division name	Graduate School of Human Health Sciences, Department of Occupational Therapy Sciences, Pre-doctoral Program
Zip code	116-0012
Address	7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL	03-3819-1211
Email	heytaihey@gmail.com

Public contact
Name of contact person	1st name Taihei Middle name Last name Sakamoto
Organization	Tokyo Metropolitan University
Division name	Graduate School of Human Health Sciences, Department of Occupational Therapy Sciences, Pre-doctoral
Zip code	116-0012
Address	7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL	03-3819-1211
Homepage URL
Email	sakamoto-taihei1@ed.tmu.ac.jp

Sponsor
Institute	Tokyo Metropolitan University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee, Tokyo Metropolitan University Arakawa Campus
Address	7-2-10 Higashiogu, Arakawa-ku, Tokyo
Tel	03-3819-1211
Email	rinri-hs@tmu.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	2022 Year 04 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	Preinitiation
Date of protocol fixation	2022 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 04 Month 01 Day
Last follow-up date	2023 Year 01 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	2022 Year 03 Month 28 Day
Last modified on	2022 Year 04 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053949