UMIN-CTR Clinical Trial

Public title

Research on a program to learn adaptive actions to go out

Acronym

Research on a learning program for going out

Scientific Title

Workshop program to learn adaptive actions for community mobility in older adults and people with physical impairments: Single arm feasibility studies

Scientific Title:Acronym

Research for workshop program for community mobility

Region

Japan

Condition

Older adults and people with physical impairments

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of the present study is to examine the feasibility and usability of a workshop program that encourages persons (older adults or people with physical impairments) to share the wisdom of adaptive behavior.

Basic objectives2

Others

Basic objectives -Others

Program feasibility (How much resources will be required to run the program? Can the workshop program promote behaviors and social interactions in the daily lives of the elderly and physically disabled?)

Program usability (Will the workshop program be acceptable to the elderly and physically challenged?)

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Percentage of program completion (the proportion of those who attended all 8 sessions)

Key secondary outcomes

< Outcomes related to going-out habits or community mobility>
Life space assessment [Backer, et al., 2003; Harada, et al., 2010]

A number of purposes for going out [Ono & Asakawa, 2021, Ono ,et al., 2023].

Primary indicators of intra-regional mobility [an original self-rated measurement based on our qualitative study].

Physical activity

<Psychological and social aspect>
Subjective well-being [OECD, 2023; WHO, n.d.]

Autonomy scale [Ono, et al, Under review]

<Outcomes related to useability and characteristics of program>
Participant's satisfaction

Net promoter scale

Resources required (especially time)

Subjects' and researchers' experiences during the program [collected by semi-structured interviews, video recordings during the sessions, and field notes].

Degree of spillover

Participant's hope to continue the program

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

A total of eight workshop programs will be conducted as an intervention. The program aims to expand going-out habits by sharing a repertoire of adaptive actions used when participants move in their communities. The program consists of 8 sessions and includes online group work (60 minutes) and field trips (up to 10 hours).

At the time of this registration, the learning goals, behavioral goals, settings, and main activities for each session have already been constructed. At the time of implementation, researchers will make progression charts describing the specific program contents for each session based on the knowledge of workshop design. The researchers will lead each session according to the charts as facilitators. However, the facilitator may change the contents of the program at any time at their discretion.

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

Age-lower limit

20

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

We assumed three major categories of participants in this study. While clear selection criteria will be established in the final clinical trial to verify the effectiveness of the program, this study, which is in the stage of examining feasibility and usability, will be divided into three major categories.

1. Community-dwelling healthy older adults (65-100 years old): This refers to older adults who are living at home without certification for long-term care or impairments.

2. Older adults with care-needs certification (65-100 years old): This refers to older adults who are certified as requiring support or care under the long-term care insurance system of Japan. Those who use long-term care insurance services as a part of comprehensive projects for long-term care prevention and daily life support are included in this category.

3. People with impairments (20-64 years old): This refers to persons with some kind of physical impairments. We mainly assume those who have physical impairments due to central nervous system diseases such as stroke or Parkinson's disease, who are often clients in the rehabilitation field. The possession of official certifications for impairments is not required.

Key exclusion criteria

Persons who require a lot of physical assistance (cases where the research team anticipates the need to provide a lot of physical assistance by researchers)

Those with significant cognitive decline.

Target sample size

20

Name of lead principal investigator

1st name	Takazumi
Middle name
Last name	ono

Organization

The University of Tokyo

Division name

Graduate School of Frontier Sciences

Zip code

277-8563

Address

Environment Building 374, 1-5-5, Kashiwanoha, Kashiwa-shi, Chiba

TEL

04-7136-5538

Email

takazumi-ono-ut@edu.k.u-tokyo.ac.jp

Name of contact person

1st name	Takazumi
Middle name
Last name	Ono

Organization

The University of Tokyo

Division name

Graduate School of Frontier Sciences

Zip code

277-8563

Address

Environment Building 374, 1-5-5, Kashiwanoha, Kashiwa-shi, Chiba

TEL

04-7136-5538

Homepage URL

Email

takazumi-ono-ut@edu.k.u-tokyo.ac.jp

Institute

The University of Tokyo

Institute

Department

Personal name

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Tokyo Metropolitan University

Name of secondary funder(s)

Organization

Office for life science research ethics and safety

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

Tel

080-7494-2644

Email

lifescience.adm@gs.mail.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

05

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

06

Month

01

Day

Date of IRB

Anticipated trial start date

2023

Year

06

Month

01

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

04

Month

19

Day

Last modified on

2024

Year

06

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057994