UMIN-ICDS Clinical Trial

Public title

A Study of the Making Meaning Game to Support Personally Important Activities Among Community-Dwelling Older Adults

Acronym

MMG Study Supporting Personally Important Activities in Older Adults

Scientific Title

Evaluation of a Novel Preventive Care Approach Incorporating Meaningful Activities into Home Programs for Older Adults

Scientific Title:Acronym

Preventive Care Study Focusing on Meaningful Activities in Older Adults

Region

Japan

Condition

Difficulties in performing personally important occupations among community-dwelling older adults

Classification by specialty

Geriatrics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine changes in self-rated performance of and satisfaction with personally important occupations selected by community-dwelling older adults from baseline to approximately two months after the Making Meaning Game (MMG). A secondary, exploratory objective is to examine whether these changes differ according to physical frailty status.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change from baseline to approximately two months after MMG in self-rated performance of the single target occupation selected during MMG, assessed using a 10-point scale.

Key secondary outcomes

1.Change from baseline to approximately two months after MMG in self-rated satisfaction with performance of the same target occupation, assessed using a 10-point scale.
2.Numbers and proportions of participants with an increase of at least two points in performance and satisfaction, respectively, over the same period, reported as supplementary descriptive measures.

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

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Participants receive one approximately 40-minute Making Meaning Game (MMG) session in groups of approximately four, facilitated by one occupational therapist or occupational therapy student. Participants sort 38 activity cards by importance, select five important activities, and then choose one activity that is important but not currently performed adequately. They identify barriers and share experiences and practical strategies for engaging in the activity. Each participant specifies what to do, when, where, and how much, and records an activity goal on a worksheet. Participants are encouraged to pursue the goal in daily life for approximately two months, after which performance of and satisfaction with the same activity are reassessed.

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

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Community-dwelling adults aged 65 years or older attending community gathering places.
2.Able to understand and respond to the study questionnaires and assessments.
3.Provided written informed consent after receiving an explanation of the study.

Key exclusion criteria

1.Unable to provide responses personally, either in writing or through an interview.
2.Certified as requiring long-term care under Japan's long-term care insurance system. Individuals certified as requiring support only are not excluded.

Target sample size

34

Name of lead principal investigator

1st name	Dai
Middle name
Last name	Segawa

Organization

Kyoto Koka University

Division name

Occupational Therapy Program, Department of Welfare and Rehabilitation, Faculty of Nursing, Welfare and Rehabilitation

Zip code

615-0882

Address

38 Nishikyogoku Kadono-cho, Ukyo-ku, Kyoto, Japan

TEL

075-874-7952

Email

d-segawa@mail.koka.ac.jp

Name of contact person

1st name	Dai
Middle name
Last name	Segawa

Organization

Kyoto Koka University

Division name

Occupational Therapy Program

Zip code

615-0882

Address

38 Nishikyogoku Kadono-cho, Ukyo-ku, Kyoto, Japan

TEL

075-874-7952

Homepage URL

Email

d-segawa@mail.koka.ac.jp

Institute

Kyoto Koka University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto Koka University Research Ethics Committee

Address

38 Nishikyogoku Kadono-cho, Ukyo-ku, Kyoto, Japan

Tel

075-325-5312

Email

js@mail.koka.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

山手地区公民館（大阪府）、健都ライブラリー（大阪府）、京都光華大学（京都府）

Date of disclosure of the study information

2026

Year

10

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

100

Results

Among 82 participants with paired assessments, adjusted performance increased from 3.89 to 4.74 (difference 0.85, 95% CI 0.32 to 1.39; p=.002), and satisfaction increased from 4.22 to 4.93 (difference 0.71, 95% CI 0.15 to 1.26; p=.013). Time-by-frailty interactions were not statistically significant.

Results date posted

2026

Year

10

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The 82 analyzed participants had a mean age of 77.12 years (SD 4.52); 22 were men and 60 were women. Forty lived with others and 42 lived alone. The mean MoCA-J score was 25.38 (SD 2.10). According to the revised J-CHS criteria, 42 were robust, 32 prefrail, and 8 frail. These characteristics describe the analyzed sample.

Participant flow

Of 104 potential participants, four were excluded: two had difficulty providing responses and two were certified as requiring long-term care. One hundred participated. Eighteen did not complete follow-up because they discontinued attendance at community gathering places. The final analysis included 82 participants with baseline and follow-up assessments.

Adverse events

No adverse events were observed.

Outcome measures

The primary outcome was change in self-rated performance of the target occupation, assessed on a 10-point scale, from baseline to approximately two months after MMG. Secondary outcomes were change in satisfaction with performance of the same occupation and the numbers and proportions with increases of at least two points in each score. The latter were supplementary descriptive measures.

Plan to share IPD

Data sharing is subject to conditions.

IPD sharing Plan description

De-identified individual participant data may be provided by the principal investigator upon reasonable request, subject to participant consent, ethical requirements, and institutional approval.

Recruitment status

Completed

Date of protocol fixation

2026

Year

02

Month

04

Day

Date of IRB

2026

Year

03

Month

06

Day

Anticipated trial start date

2026

Year

03

Month

21

Day

Last follow-up date

2026

Year

09

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

10

Month

19

Day

Last modified on

2026

Year

10

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072490