UMIN-CTR Clinical Trial

Public title

Research on values and social factors in the final stage of life

Acronym

Research on values and social factors in the final stage of life

Scientific Title

Research on values and social factors in the final stage of life

Scientific Title:Acronym

Research on values and social factors in the final stage of life

Region

Japan

Condition

Targeting all disease

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this study, we will conduct research on values in the final stage of life and related social factors by randomly sampling local residents with the cooperation of Mito City.

Basic objectives2

Others

Basic objectives -Others

In this study, we will conduct research on values in the final stage of life and related social factors by randomly sampling local residents with the cooperation of Mito City.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The values of the final stage of life, such as where they would like to spend their final days, what discussions they have had about this, and whether they would like to live longer, are to be ascertained. Next, in addition to socioeconomic status and health status, social factors such as social capital, family relationships, loneliness, and living environment are examined for their association with such values.

Key secondary outcomes

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

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Mito City residents aged 65 or older in FY2024 who are not certified as requiring long-term care

Key exclusion criteria

not applicable

Target sample size

3000

Name of lead principal investigator

1st name	Tetsuhiro
Middle name
Last name	Maeno

Organization

University of Tsukuba

Division name

Institute of Medicine

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan

TEL

029-853-3101

Email

maenote@md.tsukuba.ac.jp

Name of contact person

1st name	Takami
Middle name
Last name	Maeno

Organization

University of Tsukuba

Division name

Institute of Medicine

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan

TEL

029-853-3101

Homepage URL

Email

takami-m@md.tsukuba.ac.jp

Institute

University of Tsukuba

Institute

Department

Personal name

Organization

Mito City

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

University of Tsukuba

Address

1-1-1 Tenno-dai, Tsukuba, Ibaraki, Japan

Tel

029-853-3101

Email

takami-m@md.tsukuba.ac.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

2024

Year

10

Month

01

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

2024

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2024

Year

11

Month

01

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Data analysis:
Self-administered questionnaire survey data
- Survey method: A self-administered questionnaire on the above items will be sent by mail. Two weeks after the start of the survey, postcards will be mailed to the target respondents reminding them to respond to the survey. The survey will be explained using the self-administered questionnaire, which will be returned only if consent is obtained, and analyzed. The survey will be conducted by a survey company that has signed a contract with Mito City regarding the handling of personal information. The survey company will compile the data, and the University of Tsukuba will receive the data with the personal information removed and analyze it. The data received will include personal identifiers necessary for matching with receipts, which will be used to match with the receipt data to be analyzed as described below.
Data provided by Mito City
- Data provided to the University of Tsukuba based on an agreement between Mito City and the University of Tsukuba, and for which the consent of the research participants has been obtained, will be used as secondary data for this study.
- The data to be used for the analysis include medical and dental receipts (National Health Insurance and Late-Stage Senior Citizen's Health Care System), health checkup data, nursing care receipts, and administrative survey data from April 2017 to March 2024 in Mito City. These data will be used for analysis as health-related outcomes, such as utilization of medical and nursing care services and understanding of diseases using disease names, medical practices, and drugs administered.

Registered date

2024

Year

07

Month

31

Day

Last modified on

2024

Year

07

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062977