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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034440
Receipt No. R000039253
Scientific Title The study of effectiveness and feasibility of advanced case management for the patients with chronic diseases
Date of disclosure of the study information 2018/10/10
Last modified on 2019/08/09

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Basic information
Public title The study of effectiveness and feasibility of advanced case management for the patients with chronic diseases
Acronym The study of effectiveness and and feasibility of advanced case management
Scientific Title The study of effectiveness and feasibility of advanced case management for the patients with chronic diseases
Scientific Title:Acronym The study of effectiveness 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 effectiveness 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.Effectiveness 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 multiple medical institutions for three consecutive months or more(excluding minor departments of ophthalmology, dermatology etc.)
6.A patient has consulted frequently more than 10 days a month for the past 3 months or more
7.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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

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
2019 Year 08 Month 09 Day


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

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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