UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040045 |
|---|---|
| Receipt number | R000045646 |
| Scientific Title | Characteristics of the patients discharged to home; A prospective observational study in a local acute care hospital |
| Date of disclosure of the study information | 2020/04/03 |
| Last modified on | 2023/04/14 11:05:12 |
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Basic information
Public title
Research on practice of home medical care and home death with less burden for caregivers, patients and medical personnel
Acronym
Research on the practice of home death
Scientific Title
Characteristics of the patients discharged to home; A prospective observational study in a local acute care hospital
Scientific Title:Acronym
Characteristics of the patients discharged to home; A prospective observational study
Region
| Japan |
Condition
Condition
All adult inpatients over the age of 75
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Strength of will for discharge to home (VAS)
Basic objectives2
Others
Basic objectives -Others
Patient's age, gender, main disease of hospitalization, level of care required, attending physician, primary caregiver's mental and physical condition, time devoted to patient's care (hours/week), amount of money (yen), intensity of wish for discharge to home, home care or death at home (10 levels), patient's wish for discharge to home, home care or death at home (10 levels)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Living at home for most of the first month after discharge
Key secondary outcomes
Living at home or in care facilities for most of the first month after discharge
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who are 75 years old or older who are admitted to Yuaikai Oda Hospital, and their main caregivers
Key exclusion criteria
A patient whose consent was not obtained
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
TEL
81-952-34-3238
tagomas@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
TEL
81-952-34-3238
Homepage URL
tagomas@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Primary Care Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yuai-kai Foundation and Oda Hospital
Address
4306 Takatsuhara, Kashima, Saga 849-1311, Japan
Tel
0954-63-3275
renkei@yuai-hc.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
社会医療法人祐愛会織田病院(佐賀）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9883979/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9883979/
Number of participants that the trial has enrolled
285
Results
Total 285 patients agreed to participate. With adjustment by where the patient was admitted from, living alone, Cognitive function scores, and Barthel index, multivariable analysis for each factor following were associated with home discharge: being less informed about LTC insurance; cost of home-visit medical, nursing, or LTC services; shorter hospital stays; close proximity between patient and caregiver; main caregiver being female; and life expectancy of over 6 months (P<0.05).
Results date posted
| 2023 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 24 | Day |
Baseline Characteristics
The median age of patients was 86 (81-91) years; there were 158 women (58%). The median hospital stay was 13 (8-21) days, and the Home group comprised 191 patients (67%; Table 1).
Participant flow
During the study period, 5882 patients were admitted to the hospital; of them, 3 223 were aged 75 or over, and 312 consented to participate. After excluding 27 patients with no recorded outcome, we included 285 in this study.
Adverse events
None.
Outcome measures
We divided the patients into 2 groups according to the results of telephone inquiries performed over 30 days after discharge: those who had remained at home longer than they did elsewhere or had died at home by 30 days after discharge (the Home group); and others (the Other group).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Regarding the target patients, the following information is surveyed based on medical records or interviews: age, gender, living site before admission, family structure, level of care required, independence in elimination, the living site (home, facility, hospital) desired (at the time of admission, convalescence, and end of life) (VAS), whether the home is owned, length of living, barriers of discharge to the home (multiple choice plus one choice), and knowledge of home care services (home visits, nursing, rehearsal, nursing care, MSW, nursing care insurance, medical insurance, etc.) (four-step choice).
Regarding the primary caregivers (family members) of the target patients, the following information is surveyed using a self-described questionnaire: relationship with the patient, presence and frequency of the patient's dementia-related symptoms ( selective), distance from the patient's home, acceptable burden ( time, money) for the patient, experience in caregiving, presence or absence of a sub-caregiver, patients' living site (home, facility, hospital)( VAS) (at the time of admission, care period, end of life), barriers for patients discharge to home ( multiple-choice + selective), knowledge of home care services (home visits, nursing, rehearsal, nursing care, MSW, long-term care insurance, medical insurance, etc.) (4-choice), degree of health (SF-12v2), degree of burden of caregiving (BIC-11)
One month after discharge, a telephone survey will be conducted to investigate whether the patient is alive or dead, where ("home, facility, hospital") and how many days the patient slept and ate during the month.
Management information
Registered date
| 2020 | Year | 04 | Month | 03 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045646
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
| 2022/04/18 | 20210418 自宅退院UMIN登録用319.xlsx |
