Prevention of HCC Using Mobile Phone Applications
1 other identifier
observational
8,000
0 countries
N/A
Brief Summary
This prospective cohort study is initiated to evaluate the compliance improvement to the standardized follow-up and clinical management in the population of compensatory hepatitis B cirrhosis with a mobile health application (APP). Patients were enrolled and divided into APP self-management group (APP only ) and APP intelligent-management group (APP and online interaction). The compliance to the standardized follow-up and clinical management (every six months) under the two clinical management modes would be evaluated and compared with the history data extracted from the platform of China Registry of Hepatitis B (CR-Hep B).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedStudy Start
First participant enrolled
November 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 26, 2021
October 1, 2021
2.1 years
September 22, 2021
October 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient compliance to the standardized semi-annual follow-up
Total follow-up times with the three clinical management modes. The event of follow-up is defined as self-reported clinic visit for liver cirrhosis assessment on the mobile phone application by patients.
0 to 2 years
Secondary Outcomes (2)
Applicability of mobile phone application
0 to 2 years
Clinical performance on HCC of the three clinical management modes
0 to 2 years
Study Arms (3)
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.
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.
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).
Interventions
The APP would regularly send messages including the medication reminder, health education knowledge, etc.
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.
The APP would regularly send messages including the follow-up reminder (manually set up by the patient on the APP)
The APP would regularly send messages including the follow-up reminder (automatically set up by the APP)
Eligibility Criteria
4000 patients who have registered on the platform of China Registry of Hepatitis B (CR-Hep B) and been diagnosed as compensatory hepatitis B cirrhosis would be recruited in the study. 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.
You may qualify if:
- Registered on the CR-HepB platform
- 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:
- Diagnosis of Liver cirrhosis by histology;
- Varicose veins in Esophageal and/or gastric fundus indicated by endoscopy;
- Diagnosis of Liver cirrhosis by Imaging examination (abdominal ultrasound, CT, MRI) ;
- Liver elasticity measurement \>12.0 kpa (ALT\<5×ULN)
- 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
You may not qualify if:
- With any decompensated cirrhosis events, such as esophagogastric variceal rupture and bleeding, ascites, and hepatic encephalopathy;
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
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.
PMID: 31248666BACKGROUNDYang 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.
PMID: 9222303BACKGROUNDSingal 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.
PMID: 24691105BACKGROUNDMarrero 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.
PMID: 29624699BACKGROUNDEuropean 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.
PMID: 29628280BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jidong Jia, MD, PhD
Beijing Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Liver Research Center
Study Record Dates
First Submitted
September 22, 2021
First Posted
October 26, 2021
Study Start
November 15, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
October 26, 2021
Record last verified: 2021-10