UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effectiveness an interprofessional collaboration manual for end-of-life care of patients at home
Title of the study (Brief title)	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	Sakiko Fukui
Organization	Japanese Red Cross College of Nursing
Division name	Community Health Nursing
Address	4-1-3 Hiroo,Shibuya-ku,Tokyo
TEL	03-3409-0533
Email	sfukui@redcross.ac.jp

Public contact
Name of contact person	Sakiko Fukui
Organization	Japanese Red Cross College of Nursing
Division name	Community Health Nursing
Address	4-1-3 Hiroo,Shibuya-ku,Tokyo
TEL	03-3409-0533
Homepage URL
Email	sfukui@redcross.ac.jp

Sponsor
Institute	Japanese Red Cross College of Nursing, Community Health Nursing
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026244