UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of a disease management program focused on acquisition of self-management skills in patients with chronic hepatitis B and C in China
Title of the study (Brief title)	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	Yingai Cui
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
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	Yingai Cui
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029154