UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022579 |
|---|---|
| Receipt number | R000026013 |
| Scientific Title | Development of an integrated care pathway (ICP) for end-of-life care in long term care facilities in Japan |
| Date of disclosure of the study information | 2016/07/31 |
| Last modified on | 2022/05/30 13:32:13 |
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Basic information
Public title
Development of an integrated care pathway (ICP) for end-of-life care in long term care facilities in Japan
Acronym
Development of an integrated care pathway (ICP) for end-of-life care in long term care facilities in Japan
Scientific Title
Development of an integrated care pathway (ICP) for end-of-life care in long term care facilities in Japan
Scientific Title:Acronym
Development of an integrated care pathway (ICP) for end-of-life care in long term care facilities in Japan
Region
| Japan |
Condition
Condition
Nurses and care workers in a private nursing home in Japan
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine feasibility and efficacy of an integrated care pathway for end-of-life care in a private nursing home in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Attitude of nurses and care workers toward end-of-life care;
Nurse's attitude scale on end-of-life care towards older adults and Frommelt Attitude TowardCare Of Dying scale - Form B, Japanese version
Key secondary outcomes
1.Efficacy and feasibility of ICP evaluated by semi-structured interview to nurse and care worker
2. Interdisciplinary team practice of nurses and care workers:Assessment Scale of Health Care Professionals' Recognition of a Successful Interdisciplinary Team Approach in Health Care Facilities for the Elderly
3.Efficacy and feasibility of ICP evaluated by items developed for this project
4. Efficacy and feasibility of ICP evaluated by semi-structured interview to managers
5. Feasibility of ICP evaluated by semi-structured interview to residents, families, and bereaved family
6. Administrative data of the nursing home including the number of urgent hospitalization and mortality in the institution
7. Description in daily record of nurses and care workers and in checklist including number of conferences and description in conferences
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
An complex intervention for nurses and care workers using an integrated care pathway that is developed by the authors for Japanese private nursing homes
The ICP has 5 components;
(1) Education regarding procedure of the ICP for staffs
(2) Education regarding quality EOL care for staffs
(3) Standardized multidisciplinary checklist of EOL care process
(4) Regular interdisciplinary conference
(5) Audit of description of checklist by administrator and educators in the institution
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses and care workers in the facility.
Key exclusion criteria
Staff who cannot communicate in Japanese
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Fukahori |
Organization
Faculty of Nursing and Medical Care, KEIO UNIVERSITY
Division name
Devision of Gerontological nursing
Zip code
252-0883
Address
4411 Endo, Fujisawa-shi, Kanagawa
TEL
0466-49-6206
fukahori@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Yamagata |
Organization
The Jikei University
Division name
School Of Nursing
Zip code
182-8570
Address
8-3-1 Kokuryo-cho Choufu,Tokyo
TEL
03-3480-8686
Homepage URL
yamagata.chihiro@jikei.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Nursing and Medical Care, KEIO UNIVERSITY
Address
4411 Endo, Fujisawa-shi, Kanagawa
Tel
0466-49-6200
nmc-hm@adst.keio.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
松戸ニッセイエデンの園（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2227-9032/9/9/1194
Number of participants that the trial has enrolled
79
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
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 02 | Day |
Last modified on
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026013
