UMIN-CTR Clinical Trial

Basic information
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
Condition	gerontology
Classification by specialty	Geriatrics Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	The place where residents preference to die.
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	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

Research contact person
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

Public contact
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

Sponsor
Institute	Saga University Hospital
Institute
Department

Funding Source
Organization	The Yuumi Memorial Foundation for Home Health Care
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
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 05 Month 06 Day

Related information
URL releasing protocol	http://www.zaitakuiryo-yuumizaidan.com/data/file/data1_20220412121034.pdf
Publication of results	Published

Result
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

Progress
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

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.

Management information
Registered date	2022 Year 05 Month 06 Day
Last modified on	2022 Year 05 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046404