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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025378
Receipt No. R000029154
Scientific Title Efficacy of a disease management program focused on acquisition of self-management skills in patients with chronic hepatitis B and C in China
Date of disclosure of the study information 2016/12/23
Last modified on 2017/06/27

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Basic information
Public title Efficacy of a disease management program focused on acquisition of self-management skills in patients with chronic hepatitis B and C in China
Acronym Efficacy of a self-management program for patients with hepatitis B and C in China
Scientific Title Efficacy of a disease management program focused on acquisition of self-management skills in patients with chronic hepatitis B and C in China
Scientific Title:Acronym Efficacy of a self-management program for patients with hepatitis B and C in China
Region
Asia(except Japan)

Condition
Condition Chronic hepatitis B and C
Classification by specialty
Hepato-biliary-pancreatic medicine Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We have developed the self-management education program for patients with chronic hepatitis B and C in China. The purpose of this study is to evaluate efficacy of our program in regard to improvement of self-management skills and QOL of the patients, and discuss that this program can be used for preventing recurrence of aggravation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Chronic Liver Disease Questionnaire(CLDQ,Chinese version)
Key secondary outcomes 1.Clinical indicators
2.Psychological indicators
3.Implemention status of self-management behaviors

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 The reseacher implements self-management education for patients 2 times when they are inhospitalized. After discharge, the researcher makes phone calls to them once evevry month for 6 months.
Interventions/Control_2 During hospitalization,the patients receive usual health education by staff nurses. The researcher provides the self-manangement textbook and a brief introduction to patients. Then, the patients study it by themselves.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who have been diagnosised as chronic hepatitis B or C.
2.Patients aged 18 years old and over.
3.No limitation on patient's treatment contents (including patients on Interferon treatment).
4.Patients who can be contacted by telephone after discharge.
5.No limitation on patient's economic condition.
6.No limitation on times of patient's hospitalization.
Key exclusion criteria 1.Patients having liver diseases other than chronic hepatiis B and C.
2.Patients who have diseases which affect on liver function, judged by primary physicians.
3.Patients having a diagnosis of depression.
4.Patients having cognitive impairments (MMSE <=27).
5.Patients whose primary physicians and/or research-in-charge physicians judge the patient is not appropriate for implimentation.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yingai Cui
Organization Hiroshima University
Division name Graduate School of Biomedical & Health Sciences
Zip code
Address Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL 090-2809-9032
Email d134308@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yingai Cui
Organization Hiroshima University
Division name Graduate School of Biomedical & Health Sciences
Zip code
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL 082-257-6336
Homepage URL
Email d134308@hiroshima-u.ac.hjp

Sponsor
Institute The second people's Hospital of Tianjin, China
Institute
Department

Funding Source
Organization No funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 天津市第二人民病院(天津市,中国)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 23 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 21 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 22 Day
Last follow-up date
2017 Year 05 Month 06 Day
Date of closure to data entry
2017 Year 05 Month 22 Day
Date trial data considered complete
Date analysis concluded
2017 Year 07 Month 10 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 22 Day
Last modified on
2017 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029154

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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