UMIN-CTR Clinical Trial

Basic information
Public title	The study of efficacy and feasibility of advanced case management for the patients with chronic diseases
Acronym	The study of efficacy and and feasibility of advanced case management
Scientific Title	The study of efficacy and feasibility of advanced case management for the patients with chronic diseases
Scientific Title:Acronym	The study of efficacy and and feasibility of advanced case management
Region	Japan

Condition
Condition	The patients with chronic diseases including lifestyle related diseases and malignant tumors
Classification by specialty	Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and feasibility of advanced case management for patients with chronic diseases
Basic objectives2	Others
Basic objectives -Others	feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Efficacy of model -Medical Economic Indicators: Medical costs and long-term care costs, and how the service were used -Physical indicators: blood pressure, respiration rate, and ADL -Clinical indicators: total protein, albumin, potassium, sodium, and CRP -Psychological indicators: QOL and PHQ9 scores 2.Contents of support -Details of advanced case management 3.Feasibility -Accurately extracting patiants that we should target -Appropriateness of positioning of advanced case managers -Change of the region
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-The insured of Kure-city and Osaki National Health Insurance, and the Late Elderly Health Insurance System living in Kure-city and Osaki.Age =>20 years old. A patients fall under any of the following criteria 1 to 7. 1.A patient whose medical expenses are more than 1 million yen per month per month 2.A patient had two or more hospital admissions due to disease exacerbation last year 3.A patient had access to an intensive care unit from emergency outpatient last year 4.A patients' general condition is stable, but he can not decide on the recuperation 5.A patient has consulted frequently more than 10 days a month for the past 3 months or more 6.A patient takes more than 10 types of internal medicine
Key exclusion criteria	-Age<20 -Acute illness -Accident injuries
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Michiko Middle name Last name Moriyama
Organization	Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name	Department of Nursing
Zip code	7348553
Address	Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL	0822575365
Email	morimch@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Kana Middle name Last name Kazawa
Organization	Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name	Department of Nursing
Zip code	7348553
Address	Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL	0822575382
Homepage URL
Email	kkazawa@hiroshima-u.ac.jp

Sponsor
Institute	Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization	Kure city insurer of NHI and LEHI
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics committee of Hiroshima University
Address	Kasumi 1-2-3, Minami-ku, Hiroshima
Tel	0822571576
Email	iryo-seisaku@office.hiroshima-u.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

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 10 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 02 Month 01 Day
Date of IRB	2016 Year 02 Month 10 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry	2020 Year 09 Month 30 Day
Date trial data considered complete	2020 Year 11 Month 30 Day
Date analysis concluded	2021 Year 01 Month 31 Day

Other

Other related information

Evaluation item 1.Basic attributes -Age,gender,names of diseases 2.Medical economic indicators -Where the patient is treating -Medical and long-term care costs -Medical and long-term care services -Level of long-term care required -Contents of informal services 3.Clinical indicators -Blood test results -Vital signs blood pressure, breathing 4.Physical activity evaluation indicators -ADL -Activities and social exchanges 5.Psychological indicators -QOL, depression 6.Number of advanced care planning support 7.Qualitative evaluation for case management

Management information
Registered date	2018 Year 10 Month 10 Day
Last modified on	2021 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039253