UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022772 |
|---|---|
| Receipt number | R000026244 |
| Scientific Title | Evaluation of the effectiveness an interprofessional collaboration manual for end-of-life care of patients at home |
| Date of disclosure of the study information | 2016/06/17 |
| Last modified on | 2017/04/06 22:03:15 |
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Basic information
Public title
Evaluation of the effectiveness an interprofessional collaboration manual for end-of-life care of patients at home
Acronym
Evaluation of the effectiveness an interprofessional collaboration manual for end-of-life care of patients at home
Scientific Title
Evaluation of the effectiveness an interprofessional collaboration manual for end-of-life care of patients at home
Scientific Title:Acronym
Evaluation of the effectiveness an interprofessional collaboration manual for end-of-life care of patients at home
Region
| Japan |
Condition
Condition
home-visit nurses, care managers, managers of home helpers, family caregivers
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the created "Interprofessional collaboration manual for end-of-life care of patients at home"
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Knowledge, attitude, practice in team collaboration (before the intervention, at 7 months)
Key secondary outcomes
Job satisfaction, patient condition, evaluation of care by family caregivers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The intervention group of home-visit nurses, care managers, and managers of home helpers take 1-day training based on the "Interprofessional collaboration manual for end-of-life care of patients at home."
Interventions/Control_2
7 months after the intervention group take the training, the control group take the same training.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Home-visit nurses, care managers, and managers of home helpers who provide end-of-life care for patients at home
2) Home-visit nurses, care managers, and managers of home helpers who agreed to participate in this study
Home-visit nurses, care managers, and home-visit care managers providing terminal care in the community
Family caregivers of patients received care from the above professionals
Key exclusion criteria
We don't have any exclusion criteria.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakiko Fukui |
Organization
Japanese Red Cross College of Nursing
Division name
Community Health Nursing
Zip code
Address
4-1-3 Hiroo,Shibuya-ku,Tokyo
TEL
03-3409-0533
sfukui@redcross.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakiko Fukui |
Organization
Japanese Red Cross College of Nursing
Division name
Community Health Nursing
Zip code
Address
4-1-3 Hiroo,Shibuya-ku,Tokyo
TEL
03-3409-0533
Homepage URL
sfukui@redcross.ac.jp
Sponsor or person
Institute
Japanese Red Cross College of Nursing, Community Health Nursing
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Address
Tel
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
日本赤十字看護大学（東京都）Japanese Red Cross College of Nursing(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 17 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | 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 | 17 | Day |
Last modified on
| 2017 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026244
| 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 |
