UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000047803
Receipt number R000054495
Scientific Title A Survey on Advanced Care Planning (ACP) to Motivate Elderly People to Live in Special Nursing Homes for the Elderly
Date of disclosure of the study information 2022/06/15
Last modified on 2022/05/19 16:44:39

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Basic information

Public title

A Survey on Advanced Care Planning (ACP) to Motivate Elderly People to Live in Special Nursing Homes for the Elderly

Acronym

A Survey on Advanced Care Planning (ACP) to Motivate Elderly People to Live

Scientific Title

A Survey on Advanced Care Planning (ACP) to Motivate Elderly People to Live in Special Nursing Homes for the Elderly

Scientific Title:Acronym

A Survey on Advanced Care Planning (ACP) to Motivate Elderly People to Live in Special Nursing Homes for the Elderly

Region

Japan


Condition

Condition

Care staff (healthy people)

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to clarify the implementation status and facilitating factors of Advance Care Planning (ACP) to motivate the elderly to live in special nursing homes through a questionnaire survey targeting special nursing homes nationwide.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Basic attributes of respondents
2. Overview of the facility
3. Actual status of ACP
4. Items related to the organizational climate of the facility/ward
5. Decision-Making Support Scale for Elderly People with Dementia in Elderly Facilities

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

The following criteria are to be met by all the following persons.
[Questionnaire survey
1) Long-term care welfare facilities for the elderly (special nursing homes for the elderly) that are members of the National Council of Senior Citizens Welfare Facilities
2) Facilities that have obtained consent from the individual to participate in the study.
Interview survey
1) Respondents who agreed to be interviewed in the questionnaire survey and staff working at the facility (special nursing home for the elderly)
2) Respondents of the questionnaire survey are asked to select subjects from the nursing and care staff to determine
3) Three respondents (administrator), one nursing staff member, and one nursing staff member to respond to the questionnaire survey
4) People who are able to conduct the interview survey via ZOOM (people who have access to a computer or other mobile device)
5) Persons who can give consent to have their interviews recorded by ZOOM

Key exclusion criteria

Persons who meet any of the following criteria will not be included in this study.
[Questionnaire survey
1) Facilities that are not members of the National Council of Senior Citizens Welfare Facilities
2) Facilities other than long-term care welfare facilities for the elderly (special nursing homes for the elderly)
Interview survey
1) Staff not involved in ACP or direct care of residents
2) Persons other than administrators, caregivers, or nurses
3) Part-time or part-time workers
4) Those who are planning to take maternity leave or retire
5) Those who are coming off sick leave or maternity leave
6) Those who are on leave
7) Those who do not have access to a mobile device for interviews and surveys on ZOOM

Target sample size

200


Research contact person

Name of lead principal investigator

1st name mizue
Middle name
Last name suzuki

Organization

Faculty of Nursing

Division name

Faculty of Nursing

Zip code

431-3192

Address

1-20-1 Handayama

TEL

+81534352826

Email

mizuesuzuki@gmail.com


Public contact

Name of contact person

1st name mizue
Middle name
Last name suzuki

Organization

Hamamatsu University School of Medicine

Division name

Faculty of Nursing

Zip code

431-3192

Address

1-20-1 Handayama

TEL

+81534352826

Homepage URL


Email

mizuesuzuki@gmail.com


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hamamatsu University School of Medicine

Address

1-20-1 Handayama

Tel

+81534352826

Email

mizuesuzuki@gmail.com


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

2022 Year 06 Month 15 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


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

Enrolling by invitation

Date of protocol fixation

2021 Year 05 Month 05 Day

Date of IRB

2021 Year 06 Month 05 Day

Anticipated trial start date

2021 Year 07 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

[Questionnaire survey
There are 4,364 special nursing homes (as of February 2, 2021), and the target is 1,309 with a 30% response rate.
Interview survey
Target more than 30 persons to conduct more than 10 groups as subjects who agreed to be interviewed in the questionnaire survey.


Management information

Registered date

2022 Year 05 Month 19 Day

Last modified on

2022 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054495


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name