UMIN-CTR Clinical Trial

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
Institute	Hamamatsu University School of Medicine
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_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

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