Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT05094869
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).
Detailed Description:
Standardized follow-up and clinical management in the population of compensatory hepatitis B cirrhosis is important in the prevention of liver cancer. In the clinical practice, follow-up every six months are usually recommended. This prospective cohort study is initiated to evaluate the compliance improvement to the standardized follow-up and clinical management with a health management application (APP). 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. They were divided into two groups according to whether they use the APP and whether there is online interaction between doctors and patients:
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.
Study:
NCT05094869
Study Brief:
Protocol Section:
NCT05094869