UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047306
Receipt number R000053949
Scientific Title The Impact of a Short-Term Online Multidisciplinary Intervention on Improving the Life Challenges of Elderly People Living in the Community
Date of disclosure of the study information 2022/04/01
Last modified on 2022/04/05 20:58:56

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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 or person

Institute

Tokyo Metropolitan University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053949


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name