UMIN-CTR Clinical Trial

Public title

Comparison of patients receiving home healthcare before and after the COVID-19 pandemic

Acronym

Comparison of patients receiving home healthcare before and after the COVID-19 pandemic

Scientific Title

Comparison of patients receiving home healthcare before and after the COVID-19 pandemic

Scientific Title:Acronym

Comparison of patients receiving home healthcare before and after the COVID-19 pandemic

Region

Japan

Condition

Patients newly receiving home healthcare

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Determine changes in the number and characteristics of home healthcare recipients before and after the COVID-19 pandemic.

Basic objectives2

Others

Basic objectives -Others

This study will use medical record data from seven medical institutions providing home healthcare in Ibaraki Prefecture to identify changes in the profile of patients who newly initiated home healthcare before and after the pandemic.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Number of patients newly initiating home visits, number of patients wishing to receive end-of-life care at home

Key secondary outcomes

Patient profile (underlying disease, level of care required, care services used, number of house calls and outcomes, etc.)

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who newly started home healthcare in seven clinics/hospitals in Ibaraki prefecture (Yamato Clinic, Central General Clinic, Kitaibaraki Municipal Hospital Affiliated Family Medicine Center, Hitachi-Ota Family Medicine Clinic, Kasama City Hospital, Kamisu Saiseikai Hospital, and Saiseikai Doai Clinic) during April 1, 2019 and March 31, 2023.

Key exclusion criteria

Those who have viewed the opt-out and have informed us that they do not wish to participate in this study

Target sample size

2000

Name of lead principal investigator

1st name	YU
Middle name
Last name	SUN

Organization

University of Tsukuba

Division name

Institute of Medicine

Zip code

3058575

Address

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

TEL

029-853-3189

Email

sunyu@md.tsukuba.ac.jp

Name of contact person

1st name	YU
Middle name
Last name	SUN

Organization

University of Tsukuba

Division name

Institute of Medicine

Zip code

305-8575

Address

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

TEL

029-853-3189

Homepage URL

Email

sunyu@md.tsukuba.ac.jp

Institute

University of Tsukuba

Institute

Department

Personal name

Organization

Yumi Memorial Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

029-853-3308

Email

sien.ningenss@un.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

2023

Year

12

Month

25

Day

URL releasing protocol

https://pmc.ncbi.nlm.nih.gov/articles/PMC12276426/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/40673480/

Number of participants that the trial has enrolled

1922

Results

A total of 1,922 patients were included. After the onset of the COVID-19 pandemic, the number of patients initiating physician-led home visit care increased slightly, and the proportion of patients with cancer increased. Home death within 1 month increased during the pandemic. In the interaction model, the pandemic alone was not associated with home death, whereas the interaction between cancer and the pandemic was strongly associated. Similar results were observed at 3 and 6 months.

Results date posted

2026

Year

06

Month

28

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2025

Year

07

Month

17

Day

Baseline Characteristics

In both periods (pre- and during the COVID-19 pandemic), the most common demographics included patients aged 85 to 94 years, those with care need levels 4 and 5, spouses as primary caregivers, and 2-generation households.

Participant flow

This study was a multicenter retrospective analysis utilizing medical records from 6 enhanced Home Care Support Clinics/Hospitals (HCSCs) in the Ibaraki prefecture. The study participants were patients who initiated physician-led home visits between April 2019 and March 2023. Exclusion criteria encompassed patients under 18 years of age, those residing in facilities, and patients who received only end-of-life home visits without prior care. In this study, we extracted data only for patients who met all inclusion and exclusion criteria at the time of data extraction. Therefore, there was no stepwise selection process during the analysis, and the final study population reflects the total number of eligible patients. The participants were followed up until March 2024.

Adverse events

Nose

Outcome measures

We extracted the duration of physician-led home visit care and the clinical outcome. The duration of home visits was calculated from the start and end dates of home visits and categorized as <1 month, 2 to 3 months, 4 to 6 months, 7 to 12 months, or >1 year. Clinical outcomes were classified as died at home, hospitalization, continue, or other/unknown. The "other/unknown" category included cases such as transitioning back to outpatient care, transfer to another clinic or hospital, admission to a facility, or death outside the home.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2023

Year

12

Month

25

Day

Date of IRB

2024

Year

01

Month

19

Day

Anticipated trial start date

2024

Year

02

Month

01

Day

Last follow-up date

2024

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The following information will be extracted from the medical records, and a descriptive analysis and split time-series analysis will be conducted on the changes before and after the COVID-19 pandemic.
<Basic information at the start of the home visit>
Age, gender, place of residence (home or facility), underlying disease, family structure, relation with the main caregiver, level of care required, care services used, history of consultation (whether the patient was referred from the hospital or not), the reason for introducing home healthcare (whether the main purpose is end-of-life care at home), etc.
<Information after the start of home medical care>
Number of house calls up to September 30, 2023, chief complaint of the house call, whether the patient was hospitalized or not, cause of hospitalization, presence or absence of COVID-19 infection, and place of care to infection (continued home care, hospitalization), duration of continued home care, outcome (hospitalization, death (including cause and place of death), admission to institution), etc.

Registered date

2023

Year

12

Month

25

Day

Last modified on

2026

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060728