UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053212 |
|---|---|
| Receipt number | R000060728 |
| Scientific Title | Comparison of patients receiving home healthcare before and after the COVID-19 pandemic |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/12/25 11:48:50 |
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Basic information
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
Condition
Patients newly receiving home healthcare
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
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
Assessment
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.)
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
| 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
Research contact person
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
sunyu@md.tsukuba.ac.jp
Public contact
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
sunyu@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Yumi Memorial Foundation
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
University of Tsukuba
Address
1-1-1 Tenno-dai, Tsukuba, Ibaraki, Japan
Tel
029-853-3308
sien.ningenss@un.tsukuba.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
| 2023 | Year | 12 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
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
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.
Management information
Registered date
| 2023 | Year | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060728
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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