UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000057440
Receipt number R000065630
Scientific Title Intervention study on constructing social activity maintenance measures using nudges for community-dwelling older adults
Date of disclosure of the study information 2025/03/31
Last modified on 2026/03/30 10:58:02

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Basic information

Public title

Intervention study on constructing social activity maintenance measures using nudges for community-dwelling older adults

Acronym

Intervention study on constructing social activity maintenance measures using nudges for community-dwelling older adults

Scientific Title

Intervention study on constructing social activity maintenance measures using nudges for community-dwelling older adults

Scientific Title:Acronym

Intervention study on constructing social activity maintenance measures using nudges for community-dwelling older adults

Region

Japan


Condition

Condition

Community-dwelling older adults who participate in social activities but feel reluctant

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine whether a social activity maintenance measures using nudges targeting community-dwelling older adults who participate in neighborhood association activities but feel reluctant to do so is effective in maintaining the frequency of participation in social activities.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number of participation in target neighborhood association activities
Frequency of social activities (Personal activities, Social activities, Learning Activities, Work)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Distributing information leaflets using nudges one month before the neighborhood association activity.
Provide information on social activities and hold group meetings during neighborhood association activities.
A questionnaire survey on social activities will be conducted at baseline and 2 and 4 months after baseline.

Interventions/Control_2

Control group
A questionnaire survey on social activities will be conducted at baseline and 2 and 4 months after baseline.

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

People who live in two districts (A and B) in one local city in Hokkaido
People who participate in neighborhood association activities
People who have not been certified as needing nursing care or assistance

Key exclusion criteria

People who do not live in one of the two districts (A and B districts) of a local city in Hokkaido
People who do not participate in neighborhood association activities
People who have been certified as needing nursing care or assistance

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Wakako
Middle name
Last name Mizuguchi

Organization

Asahikawa Medical University

Division name

School of Nursing, Faculty of Medicine

Zip code

078-8510

Address

2-1-1-1 Midorigaoka Higashi, Asahikawa City, Hokkaido

TEL

0166-68-2942

Email

mizu-w@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name Wakako
Middle name
Last name Mizuguchi

Organization

Asahikawa Medical University

Division name

School of Nursing, Faculty of Medicine

Zip code

078-8510

Address

2-1-1-1 Midorigaoka Higashi, Asahikawa City, Hokkaido

TEL

0166-68-2942

Homepage URL


Email

mizu-w@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee , Asahikawa Medical University

Address

2-1-1-1 Midorigaoka Higashi, Asahikawa City, Hokkaido

Tel

0166-68-2297

Email

rs-kp.g@asahikawa-med.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

2025 Year 03 Month 31 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

21

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

No longer recruiting

Date of protocol fixation

2025 Year 02 Month 21 Day

Date of IRB

2025 Year 04 Month 02 Day

Anticipated trial start date

2025 Year 10 Month 06 Day

Last follow-up date

2026 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 03 Month 28 Day

Last modified on

2026 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065630