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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040045
Receipt No. 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 2020/04/03

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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
Email 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
Email tagomas@cc.saga-u.ac.jp

Sponsor
Institute Saga University Hospital
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 118
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 No longer recruiting
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
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045646

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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