UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025378 |
|---|---|
| Receipt number | 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 09:27:21 |
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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
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
d134308@hiroshima-u.ac.hjp
Sponsor or person
Institute
The second people's Hospital of Tianjin, China
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029154
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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