UMIN-CTR Clinical Trial

Public title

The 'Ready to Talk' intervention to enhance readiness for advance care planning for community-dwelling frail older adults in Japan: A feasibility study

Acronym

The 'Ready to Talk' intervention to enhance readiness for advance care planning for community-dwelling frail older adults in Japan: A feasibility study

Scientific Title

The 'Ready to Talk' intervention to enhance readiness for advance care planning for community-dwelling frail older adults in Japan: A feasibility study

Scientific Title:Acronym

The 'Ready to Talk' intervention to enhance readiness for advance care planning for community-dwelling frail older adults in Japan: A feasibility study

Region

Japan

Condition

Frailty

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the feasibility, acceptability, and fidelity of an intervention 'Ready to Talk' to empower community-dwelling frail older adults' readiness to engage with advance care planning in Japan.

Basic objectives2

Others

Basic objectives -Others

[Stage 1: Training for home care managers]
1. To examine if the training improves understanding of the concept of ACP and the content of the intervention 'Ready to Talk'
2. To explore what ways the training motivates home care managers to conduct the 'Ready to Talk' intervention
3. To explore what ways the training is helpful for home care managers to conduct 'Ready to Talk' intervention

[Stage 2: Intervention of 'Ready to Talk']
1. To evaluate the feasibility of home care managers using the 'Ready to Talk' intervention.
2. To explore the acceptability of the 'Ready to Talk' intervention for older adults, family carers, and home care managers.
3. To evaluate the process of how the 'Ready to Talk' intervention can support individuals' readiness for ACP.
4. To identify opportunities to strengthen the 'Ready to Talk' intervention and refine the intervention logic model.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Feasibility: The number of older adults and family members approached by care managers, the number who provided consent, and reasons for declining participation. The time required to conduct the intervention. The potential impact of training and the 'Ready to Talk' intervention on readiness for ACP.
Fidelity: The extent to which care managers could deliver the planned intervention content.
Acceptability: Whether the intervention was helpful for older adults, family members, and care managers.

The principal investigator will conduct follow-up meetings with one representative from each home care support office every two weeks, with content recorded in field notes.
Within five days after the intervention, an interview survey will be conducted with older adults and family members, and a questionnaire will be conducted with care managers.

Key secondary outcomes

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

Other

Interventions/Control_1

Stage 1: Training for care managers
Providing training consisting of:
(1) What is advance care planning for frail older adults?; (2) Introduction to the intervention Ready to Talk; (3) Practice of the intervention through role-play;
(4) Instruction on the overview of the feasibility study

Stage 2: Conducting 'Ready to Talk'
Conducting the intervention 'Ready to Talk' with 6 steps:
(1) Normalising the topic; (2) Gaining permission to continue the conversation; (3) Asking "what matters most to you?"; (4) Exploring why it is important; (5) Identifying when they wish to have conversations on this topic

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

[Older adults]
1. Aged 65 and over
2. Residing at home in Izumisano City, Osaka, Japan
3. Receiving long-term home care services through the long-term care insurance system
4. Identified as pre-frail or frail (Clinical Frailty Scale: score 4 to 8)
5. Demonstrates decisional capacity to consent and participate in an intervention and individual interview, assessed using Mental Capacity Act criteria

[Family carers]
1. Aged 18 and over
2. Supporting a community-dwelling frail older adult as an informal carer
3. Includes all types of family members, regardless of relationship with the older adult, as well as close friends
4. Demonstrates decisional capacity to consent and participate in an individual interview, assessed using Mental Capacity Act criteria

[Home care managers]
1. Aged 18 and over
2. Providing home care services for frail older adults

Key exclusion criteria

[Frail older adults]
Frail older adults who are hospitalised or institutionalised

Target sample size

45

Name of lead principal investigator

1st name	Miki
Middle name
Last name	Fujimoto

Organization

King's College London

Division name

Cicely Saunders Institute

Zip code

SE5 9PJ

Address

Bessemer Road, London, UK SE5 9PJ

TEL

+44(0)2078485516

Email

miki.fujimoto@kcl.ac.uk

Name of contact person

1st name	Miki
Middle name
Last name	Fujimoto

Organization

King's College London

Division name

Cicely Saunders Institute

Zip code

SE5 9PJ

Address

Bessemer Road, London, UK SE5 9PJ

TEL

07091038115

Homepage URL

Email

miki.fujimoto@kcl.ac.uk

Institute

King's College London

Institute

Department

Personal name

Organization

Osakagasgroup Welfare Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Office, King's College London

Address

3rd Floor, 5-11 Lavington Street, London, UK, SE1 0NZ

Tel

+44 (0)20 7836 5454

Email

rec@kcl.ac.uk

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

2024

Year

11

Month

07

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

Open public recruiting

Date of protocol fixation

2024

Year

09

Month

17

Day

Date of IRB

2024

Year

08

Month

15

Day

Anticipated trial start date

2024

Year

11

Month

06

Day

Last follow-up date

2025

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

11

Month

06

Day

Last modified on

2024

Year

11

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064070