UMIN-ICDS Clinical Trial

Public title

A study of communication strategies used by caregivers when talking with older adults with dementia

Acronym

Caregiver Conversation Study

Scientific Title

An observational study of communication skills used by caregivers in conversations with older adults with dementia

Scientific Title:Acronym

Formalization of Caregiver Communication Skills

Region

Japan

Condition

Dementia

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to identify, describe, and organize the communication strategies and skills used by caregivers when conversing with older adults with dementia. Semi-structured interviews will be conducted with caregivers to explore the points they consider important and the practical strategies they use during conversations. In addition, free conversations between caregivers and older adults with dementia will be recorded using video, audio, and eye-tracking measures. These data will be analyzed to exploratively characterize communication skills used in actual caregiving settings, including verbal content, timing of utterances, topic development, ways of ending conversations, and gaze behavior.

Basic objectives2

Others

Basic objectives -Others

Exploratory description of communication skills used by caregivers in conversations with older adults with dementia

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Components of communication skills used by caregivers during conversations with older adults with dementia. Semi-structured interviews and video and audio recordings of free conversations lasting up to 30 minutes will be analyzed to describe and classify caregivers' communication strategies, including points they consciously consider during conversations, verbal content, timing of utterances, topic development, and ways of ending conversations.

Key secondary outcomes

Caregivers' gaze data will be recorded using an eye-tracking system during free conversations lasting up to 30 minutes. Gaze targets, temporal characteristics of gaze behavior, and their relationships with caregiver utterances and the behavior of older adults with dementia will be analyzed.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Caregivers working at the participating facility who provide care for older adults with dementia and who provide informed consent to participate in the study.

2. Older adults with dementia using the participating facility who are able to engage in conversation to the extent required for the study and for whom consent to participate is obtained from the participant or a legally authorized representative. Independence level 1-3 according to the Japanese criteria for independence in daily living of older adults with dementia will be used as a reference. However, participants will not be excluded solely on this basis if facility staff familiar with the individual judge that the person is able to engage in the required conversation.

Key exclusion criteria

Individuals who are considered to be at substantial health risk from participation in the study or who are unable to engage in conversation to the extent required for the study.

Target sample size

10

Name of lead principal investigator

1st name	Shota
Middle name
Last name	Okabe

Organization

Chiba University

Division name

Graduate School of Global and Transdisciplinary Studies

Zip code

263-8522

Address

1-33, Yayoi-cho, Inage-ku, Chiba city, 263-8522, Japan

TEL

043-290-3628

Email

sokabe@chiba-u.jp

Name of contact person

1st name	Shota
Middle name
Last name	Okabe

Organization

Chiba University

Division name

Graduate School of Global and Transdisciplinary Studies

Zip code

263-8522

Address

1-33, Yayoi-cho, Inage-ku, Chiba city, 263-8522, Japan

TEL

043-290-3628

Homepage URL

Email

sokabe@chiba-u.jp

Institute

Chiba University

Institute

Department

Personal name

Organization

Ministry of Economy, Trade and Industry

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

The Harmony Inc.

Name of secondary funder(s)

Departmental Research Funds

Organization

Research Ethics Committee, Graduate School of Global and Transdisciplinary Studies, Chiba University

Address

1-33, Yayoi-cho, Inage-ku, Chiba city, 263-8522, Japan

Tel

043-290-2917

Email

nishi-rinri@chiba-u.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

2026

Year

09

Month

10

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

2026

Year

08

Month

07

Day

Date of IRB

2026

Year

08

Month

07

Day

Anticipated trial start date

2026

Year

09

Month

17

Day

Last follow-up date

2030

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a prospective, exploratory, cross-sectional observational study of communication between caregivers and older adults with dementia.

Participants will include caregivers working at the participating facility and older adults with dementia using the facility who meet the eligibility criteria and provide consent to participate in the study. Participants will not be randomly sampled. Potential participants will be informed about the study at the participating facility, and those who express willingness to participate and meet the eligibility criteria will be enrolled. For older adults with dementia, their ability to engage in the conversations required for the study will be determined in consultation with facility staff who are familiar with their condition.

Caregivers will participate in semi-structured interviews lasting up to approximately 30 minutes to explore the points they consider important and the practical strategies they use when communicating with older adults with dementia. In addition, one-to-one free conversations between caregivers and older adults with dementia will be recorded for up to 30 minutes. The researchers will not specify particular conversation topics or conversational styles.

Data collected will include caregivers' age, sex, years of caregiving experience, and indicators of caregiving skills; older adults' age, sex, and level of independence in daily living for older adults with dementia; audio recordings and transcripts of the semi-structured interviews; video and audio recordings of the conversations; and caregivers' gaze data obtained using an eye-tracking system.

These data will be analyzed qualitatively and quantitatively to exploratively describe and organize communication strategies, verbal behaviors, and gaze behaviors used by caregivers when communicating with older adults with dementia.

Registered date

2026

Year

09

Month

04

Day

Last modified on

2026

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071855