Liver CirrhosisNCT05094869

Prevention of HCC Using Mobile Phone Applications

An observational study of Liver Cirrhosis and Hepatitis B, run by Beijing Friendship Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Liver Cirrhosis, Hepatitis B
What is being tested?: Use of mobile health application, Online interaction and Self follow-up reminders
Type of treatment: Lifestyle or therapy programme
How many people: 8,000 participants
Where: No sites listed yet
Study dates: 15 Nov 2021to 31 Dec 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 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.

Who may be able to join

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) ;

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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

Who cannot join

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;

Trial locations and contacts

No sites are listed yet.

Yuanyuan Kong, PhD contact

86-10-63139364

kongyy@ccmu.edu.cn

Jidong Jia, MD, PhD contact

86-13501378269

jia_jd@ccmu.edu.cn

About this study

Official title: Prevention of HCC Using Mobile Phone Applications: A Disease Management Project Based on CR-HepB Platform

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).

Read the 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:

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.
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: Liver Cirrhosis, Hepatitis B
Being tested: Use of mobile health application, Online interaction, Self follow-up reminders, Intelligent follow-up reminders
Keywords: Compensatory hepatitis B cirrhosis, Health management, Mobile health application, Compliance
Medical subject headings: Liver Cirrhosis, Hepatitis B, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Use of mobile health applicationBehavioural
The APP would regularly send messages including the medication reminder, health education knowledge, etc.
Online interactionBehavioural
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 remindersBehavioural
The APP would regularly send messages including the follow-up reminder (manually set up by the patient on the APP)
Intelligent follow-up remindersBehavioural
The APP would regularly send messages including the follow-up reminder (automatically set up by the APP)

Study groups in NCT05094869
Study group	Role	What they receive
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. Receives: Behavioral: Use of mobile health application; Behavioral: Self follow-up reminders
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. Receives: Behavioral: Use of mobile health application; Behavioral: Online interaction; Behavioral: Intelligent follow-up reminders
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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0 to 2 years

Secondary outcomes (2)

Applicability of mobile phone application
Applicability of mobile phone application is defined as cumulative minutes of APP use over the study period, which is recorded by APP itself.
Measured: 0 to 2 years
Clinical performance on HCC of the three clinical management modes
Clinical performance on HCC is defined as the proportion of early stage HCC among all detected HCC. The event of HCC is measured with self-reported HCC and the stage on the mobile phone application by patients.
Measured: 0 to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202131 Dec 2023

First posted26 Oct 2021
Study start15 Nov 2021 (estimated)
Primary completion31 Dec 2023 (estimated)
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Liver CirrhosisStudies of the same condition, open and under way.
More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 8,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05094869
Sponsor's protocol ID: YYYXYJ-2021-182
Status last verified: Oct 2021
First submitted: 22 Sep 2021
Last updated: 26 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 31248666
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.
PubMed 9222303
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.
PubMed 24691105
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.
PubMed 29624699
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.
PubMed 29628280

Want to know more?

Yuanyuan Kong, PhD

86-10-63139364

kongyy@ccmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of HCC Using Mobile Phone Applications: A Disease Management Project Based on CR-HepB Platform
ClinicalTrials.gov ID: NCT05094869
Acronym / sponsor ID: YYYXYJ-2021-182
Conditions: Liver Cirrhosis, Hepatitis B
Keywords: Compensatory hepatitis B cirrhosis, Health management, Mobile health application, Compliance
Study type: Observational
Recruitment status: Unknown status
Enrolment: 8,000 participants (estimated)
Lead sponsor: Beijing Friendship HospitalUniversity, hospital or other
Study start: 15 Nov 2021 (estimated)
Primary completion: 31 Dec 2023 (estimated)
Study completion: 31 Dec 2023 (estimated)
First posted: 26 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.
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.

The compliance to the standardized follow-up and clinical management (every six months) under the three clinical management modes would be evaluated.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
APP self-management group	–	Behavioral: Use of mobile health application, Behavioral: Self follow-up remindersPatients 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	–	Behavioral: Use of mobile health application, Behavioral: Online interaction, Behavioral: Intelligent follow-up remindersPatients 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).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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.

Key inclusion criteria (9 listed)

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:
Completing the informed consent form

Key exclusion criteria (4 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Use of mobile health applicationThe APP would regularly send messages including the medication reminder, health education knowledge, etc.	Behavioural	APP intelligent-management group, APP self-management group
Online interactionThe 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.	Behavioural	APP intelligent-management group
Self follow-up remindersThe APP would regularly send messages including the follow-up reminder (manually set up by the patient on the APP)	Behavioural	APP self-management group
Intelligent follow-up remindersThe APP would regularly send messages including the follow-up reminder (automatically set up by the APP)	Behavioural	APP intelligent-management group

Primary outcome

Patient compliance to the standardized semi-annual follow-up
Time frame: 0 to 2 years
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.

2 secondary outcomes

Applicability of mobile phone application
Time frame: 0 to 2 years
Clinical performance on HCC of the three clinical management modes
Time frame: 0 to 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
Background: PubMed 31248666Zhou 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.
Background: PubMed 9222303Yang 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.
Background: PubMed 24691105Singal 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.
Background: PubMed 29624699Marrero 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.
Background: PubMed 29628280European 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuanyuan Kong, PhD contact

86-10-63139364

kongyy@ccmu.edu.cn

Jidong Jia, MD, PhD contact

86-13501378269

jia_jd@ccmu.edu.cn

Jidong Jia, MD, PhD principal investigator

Beijing Friendship Hospital

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cirrhosis and Hepatitis B, run by Beijing Friendship Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuanyuan Kong, PhD (86-10-63139364, kongyy@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient compliance to the standardized semi-annual follow-up (time frame: 0 to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05094869, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.