UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034440 |
|---|---|
| Receipt number | R000039253 |
| Scientific Title | The study of efficacy 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 | 2021/12/06 11:52:57 |
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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
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
kkazawa@hiroshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
