UMIN-CTR Clinical Trial

Public title

Survey on Attitudes toward Home Care and Dying at Home in Mitsuse Village, Saga City

Acronym

Preference for home care and dying at home among older people.

Scientific Title

Factors influencing preference for receiving care and dying at home among older people: a cross-sectional study in a rural, depopulated, and super-aged area of Japan.

Scientific Title:Acronym

Preference for receiving care and dying at home among older people in a rural area of Japan

Region

Japan

Condition

gerontology

Classification by specialty

Geriatrics	Nursing	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The place where residents wish to spend a period of recuperation; At home, facilities or hospital.

Basic objectives2

Others

Basic objectives -Others

Get a hint of what the community or residents need to meet the wishes of residents.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The place where residents preference to die.

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

All residents aged 65 years or older living in Mitsuse Village, Saga City in February and June 2020.

Key exclusion criteria

Individuals who were hospitalized or institutionalized and those with moderate or severe cognitive impairment were excluded. Those that did not consent to this study were also excluded.

Target sample size

360

Name of lead principal investigator

1st name	Masaki
Middle name
Last name	Tago

Organization

Saga University Hospital

Division name

Department of General Medicine

Zip code

849-8501

Address

5-1-1 Nabeshima Saga, Saga, Japan

TEL

+81-952-34-3238

Email

tagomas@cc.saga-u.ac.jp

Name of contact person

1st name	Naoko
Middle name	E
Last name	Katsuki

Organization

Saga University Hospital

Division name

Department of General Medicine

Zip code

849-8501

Address

5-1-1 Nabeshima Saga, Saga, Japan

TEL

+81-952-34-3238

Homepage URL

Email

d4180@cc.saga-u.ac.jp

Institute

Saga University Hospital

Institute

Department

Personal name

Organization

The Yuumi Memorial Foundation for Home Health Care

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

CRINICAL RESEARCH CENTER, SAGA UNIVERSITY HOSPITAL

Address

5-1-1 Nabeshima, Saga, Saga, Japan

Tel

+81-952-34-3400

Email

kenkyu-shinsei@ml.cc.saga-u.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

2022

Year

05

Month

06

Day

URL releasing protocol

http://www.zaitakuiryo-yuumizaidan.com/data/file/data1_20220412121034.pdf

Publication of results

Published

URL related to results and publications

http://www.zaitakuiryo-yuumizaidan.com/data/file/data1_20220412121034.pdf

Number of participants that the trial has enrolled

211

Results

46.9% of residents preferred to die at home. Univariate analysis showed that Group H was significantly older (78 vs. 75 years, p=0.010) and included a higher proportion who used public transportation or did not use any transportation (20% vs. 8%, p=0.036). Multivariate analysis showed that male sex and not having a primary care physician were significantly associated with a preference to die at home (p=0.031 and 0.041)

Results date posted

2022

Year

05

Month

02

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The median age of included participants was 77 years (interquartile range: 71-84), and 44% were men. The median VAS score for health status was 32 (interquartile range: 19-52), and that of the LSNS-6 was 8 (interquartile range: 6-10) out of maximum score of 15.In total, 87% of participants reported that they used a vehicle that they drove themselves, such as a private car, motorcycle, or an electric cart. Thirteen percent of participants lived alone; the mean number of people in participants' household was 2 (interquartile range: 1-4). Sixty-four percent of participants regularly visited the clinic in the village. Five percent of participants did not have a primary care physician. The most popular type of public medical insurance was Insurance of Medical Care System for Senior Citizens aged 75 years or older requiring the policyholder to pay only 10% or 20% of the medical fee, accounting for 56%. A total of 54% of respondents had previously been hospitalized or institutionalized in a long-term care facility. Additionally, 32% had discussed with their family members how they would like to spend their final years of life. Concerning participants' involvement in the public long-term care insurance system of Japan, 13% were currently certified for long-term care, and 61% had knowledge about the system but were not certified. Concerning participants' involvement with the community comprehensive support center, 18% had used it, and 49% had knowledge about the center but had never used it.

Participant flow

A total of 360 individuals aged 65 or older were living in Mitsuse Village in January 2020. In the group surveys conducted in February 2020, we received responses from 55 people. Once we were prevented from attending meetings and conducting group surveys at the community center because of the COVID-19 pandemic, we changed to administering self-report surveys. We targeted 234 village residents, after excluding 43 who met the exclusion criteria; 168 people completed the surveys (response rate 72%). A total of 211 participants were finally included, after excluding 12 who gave invalid answers. The total study population from both the group and individual self-report surveys was 223 older village residents, with an overall response rate of 62%.

Adverse events

Nothing

Outcome measures

The proportion of participants currently receiving long-term care at home and being in an environment where such care was available if currently required was 14%. The median VAS score regarding the wish to remain at home in later life even without the ability to use the toilet independently was 65 (interquartile range: 44-87); the VAS score was 77 (interquartile range: 22-85) for the wish to remain at home with life expectancy less than 6 months. As for the preferred place to die, 46.9%, 16.6%, and 28.9% of participants reported that their preference was at home, a long-term care facility, and a hospital, respectively.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

11

Month

15

Day

Date of IRB

2019

Year

11

Month

20

Day

Anticipated trial start date

2020

Year

02

Month

01

Day

Last follow-up date

2020

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

In February 2020, residents 65 years of age and older living in Mitsuse Village will be surveyed on the following items:
age; sex; whether they were certified to receive support/long-term care; current deterioration of health condition; activities involving going out of the home; degree of social isolation; the usual means of transportation ; whether living with any family members; the number of people living with the participant; whether the participant regularly visits the clinic in the village; whether the participant has a primary care physician; type of public medical insurance; past experience of being hospitalized or institutionalized in a long-term care facility; whether the participant has discussed with family members how they would like to spend their later life years; involvement in the public long-term care insurance system of Japan and the community comprehensive support center; whether care was available for the participant/other family members even without the ability to use the toilet independently; whether end-of-life care was available for participants/other family members with a life expectancy less than 6 months; whether the participant wishes to remain at home during the final years of life or with a life expectancy less than 6 months; whether the participant wished to let other family members remain at home during the final years of life or with a life expectancy less than 6 months; and where the participant would like to die.

Registered date

2022

Year

05

Month

06

Day

Last modified on

2022

Year

05

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046404