Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
8000 participants
OBSERVATIONAL
2021-11-15
2023-12-31
Brief Summary
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Detailed Description
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1. APP self-management group (APP only, N=1000): Patients would register on the APP and visit the clinics according to the routine practice and guidelines. During the study, the APP would regularly send messages including the follow-up reminder (manually set up by the patients on the APP), medication reminder, health education knowledge, etc.
2. APP intelligent-management group (APP and online interaction, N=3000): Patients would register on the APP and visit the clinics according to the routine practice and guidelines. During the study, the APP would regularly send messages including the follow-up reminder (automatically set up by the APP), medication reminder, health education knowledge, etc. The doctors will evaluate their disease progression every six months through the APP and guide patients' clinical practice accordingly.
Patients in these two groups would be followed up for 2 years after enrollment. Besides, history data of another 4000 Patients who have been on the platform of China Registry of Hepatitis B (CR-Hep B) and been diagnosed as compensatory hepatitis B cirrhosis would be extracted and serve as the control group (No APP and No online interaction, N=4000).
The compliance to the standardized follow-up and clinical management (every six months) under the three clinical management modes would be evaluated.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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APP self-management group
Patients would register on the APP and visit the clinics according to the routine practice and guidelines. During the study, the APP would regularly send messages including the follow-up reminder (manually set up by the patients on the APP), medication reminder, health education knowledge, etc.
Use of mobile health application
The APP would regularly send messages including the medication reminder, health education knowledge, etc.
Self follow-up reminders
The APP would regularly send messages including the follow-up reminder (manually set up by the patient on the APP)
APP intelligent-management group
Patients would register on the APP and visit the clinics according to the routine practice and guidelines. During the study, the APP would regularly send messages including the follow-up reminder (automatically set up by the APP), medication reminder, health education knowledge, etc. The doctors will evaluate their disease progression every six months through the APP and guide patients' clinical practice accordingly.
Use of mobile health application
The APP would regularly send messages including the medication reminder, health education knowledge, etc.
Online interaction
The patients would be able to upload their examination results in the APP and then the doctors will evaluate their disease progression every six months through the APP and guide patients' clinical practice accordingly.
Intelligent follow-up reminders
The APP would regularly send messages including the follow-up reminder (automatically set up by the APP)
Control group
History data of another 4000 Patients who have been on the platform of China Registry of Hepatitis B (CR-Hep B) and been diagnosed as compensatory hepatitis B cirrhosis would be extracted and serve as the control group (No APP, no follow-up reminders, no online interaction).
No interventions assigned to this group
Interventions
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Use of mobile health application
The APP would regularly send messages including the medication reminder, health education knowledge, etc.
Online interaction
The patients would be able to upload their examination results in the APP and then the doctors will evaluate their disease progression every six months through the APP and guide patients' clinical practice accordingly.
Self follow-up reminders
The APP would regularly send messages including the follow-up reminder (manually set up by the patient on the APP)
Intelligent follow-up reminders
The APP would regularly send messages including the follow-up reminder (automatically set up by the APP)
Eligibility Criteria
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Inclusion Criteria
* Requiring or receiving antiviral therapy using nucleoside (acid) analogues (recommended as the first-line therapy in the 2019 Chinese Guidelines for Chronic Hepatitis B Prevention and Treatment )
* Diagnosed as compensatory hepatitis B cirrhosis, with the diagnostic criteria fitting any of the following criteria:
1. Diagnosis of Liver cirrhosis by histology;
2. Varicose veins in Esophageal and/or gastric fundus indicated by endoscopy;
3. Diagnosis of Liver cirrhosis by Imaging examination (abdominal ultrasound, CT, MRI) ;
4. Liver elasticity measurement \>12.0 kpa (ALT\<5×ULN)
5. Platelet PLT lower than the lower limit of normal value, and Serum albumin (ALB) lower than 35 g/L or international standardized ratio (INR) \>1.3.
* Completing the informed consent form
Exclusion Criteria
* With any malignant tumor;
* With serious illness on any vital organs and systems, including heart, lungs, kidneys, and blood;
* Unsuitable for participating the study deemed by researchers;
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Jidong Jia
Director of Liver Research Center
Principal Investigators
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Jidong Jia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Central Contacts
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References
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Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
Yang B, Zhang B, Xu Y, Wang W, Shen Y, Zhang A, Xu Z. Prospective study of early detection for primary liver cancer. J Cancer Res Clin Oncol. 1997;123(6):357-60. doi: 10.1007/BF01438313.
Singal AG, Pillai A, Tiro J. Early detection, curative treatment, and survival rates for hepatocellular carcinoma surveillance in patients with cirrhosis: a meta-analysis. PLoS Med. 2014 Apr 1;11(4):e1001624. doi: 10.1371/journal.pmed.1001624. eCollection 2014 Apr.
Marrero JA, Kulik LM, Sirlin CB, Zhu AX, Finn RS, Abecassis MM, Roberts LR, Heimbach JK. Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2018 Aug;68(2):723-750. doi: 10.1002/hep.29913. No abstract available.
European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. J Hepatol. 2018 Jul;69(1):154-181. doi: 10.1016/j.jhep.2018.03.018. Epub 2018 Apr 5. No abstract available.
Other Identifiers
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YYYXYJ-2021-182
Identifier Type: -
Identifier Source: org_study_id