- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04241575
Identification of Fatty Liver With Advanced Fibrosis in Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages
Identification of Fatty Liver With Advanced Fibrosis in Patients With Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
This will be a parallel group, randomized controlled trial. Patients fulfilling the inclusion and exclusion criteria above will be randomized 1:1 to two groups. Randomization will be carried out through the use of computer-generated list of random numbers in variable blocks of 4 to 10. Concealment of group allocation will be achieved through putting the group allocation cards in consecutively-numbered and sealed envelopes. The patients and physicians will know that the patients are in the intervention group if they see the reminder messages. When they do not see a reminder message, there will not be a specific indicator of whether the patient is in the control group or in the intervention group but having low fibrosis scores. Furthermore, the outcome assessors will be blinded to the group assignment.
For patients in the intervention group, we will calculate the fibrosis scores. For patients with increased fibrosis scores, we will type the following pop-up message in our electronic clinical management system:
"This patient has high Fibrosis-4 index (and/or AST-to-platelet ratio index) of xxx suggestive of significant liver fibrosis. Please consider referring the patient to the hepatology clinic or arranging further test such as FibroScan."
The reminder message will pop up when physicians see the patient at the clinic and use the electronic clinical management system. The message will remain active for one year. Although the message is entered manually at this stage, the arrangement mimics an automated computer system. If the study results are positive, the next step is to modify the system to automate the process.
Patients in the control group will undergo the same assessments as patients in the intervention group. Although physicians will have access to the raw liver biochemistry results and platelet count, the fibrosis score results will not be specifically shown, and there will be no electronic reminder messages regardless of the fibrosis scores. This is to mimic usual care when there is no dedicated care model for case identification.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-70 years
- Having type 2 diabetes
- Provided informed written consent
Exclusion Criteria:
- Type 1 diabetes
- Already receiving specialist care by gastroenterologists or hepatologists
- Current or past history of hepatocellular carcinoma or liver decompensation
- Active malignancies other than hepatocellular carcinoma, unless in complete remission for more than 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
For patients in the intervention group, we will calculate the fibrosis scores. For patients with increased fibrosis scores, we will type the following pop-up message in our electronic clinical management system: "This patient has high Fibrosis-4 index (and/or AST-to-platelet ratio index) of xxx suggestive of significant liver fibrosis. Please consider referring the patient to the hepatology clinic or arranging further test such as FibroScan." The reminder message will pop up when physicians see the patient at the clinic and use the electronic clinical management system. The message will remain active for one year. Although the message is entered manually at this stage, the arrangement mimics an automated computer system. If the study results are positive, the next step is to modify the system to automate the process. |
For patients in the intervention group, we will calculate the fibrosis scores. For patients with increased fibrosis scores, we will type the following pop-up message in our electronic clinical management system: "This patient has high Fibrosis-4 index (and/or AST-to-platelet ratio index) of xxx suggestive of significant liver fibrosis. Please consider referring the patient to the hepatology clinic or arranging further test such as FibroScan." The reminder message will pop up when physicians see the patient at the clinic and use the electronic clinical management system. The message will remain active for one year. Although the message is entered manually at this stage, the arrangement mimics an automated computer system. If the study results are positive, the next step is to modify the system to automate the process. |
No Intervention: Control group
Patients in the control group will undergo the same assessments as patients in the intervention group.
Although physicians will have access to the raw liver biochemistry results and platelet count, the fibrosis score results will not be specifically shown, and there will be no electronic reminder messages regardless of the fibrosis scores.
This is to mimic usual care when there is no dedicated care model for case identification.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Action on suspected advanced liver fibrosis
Time Frame: Within 1 year of the baseline visit
|
Proportion of patients with high fibrosis scores who are referred for specialist care or further liver assessments
|
Within 1 year of the baseline visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Referral for specialist care
Time Frame: Within 1 year of the baseline visit
|
The proportion of patients referred for specialist care or further liver assessments, regardless of fibrosis score results
|
Within 1 year of the baseline visit
|
Inappropriate referral for specialist care
Time Frame: Within 1 year of the baseline visit
|
The proportion of patients with low fibrosis scores who are referred for specialist care.
Because NAFLD is highly prevalent and only a minority of patients have advanced fibrosis, referral of patients who will unlikely develop liver-related complications to specialists represents inefficient use of precious healthcare resource and should be minimized.
This notion has major resource implications, and the current study will provide important information to guide healthcare policy.
We recognize that physicians may have other reasons to refer patients for specialist care (e.g.
newly diagnosed viral hepatitis).
The reasons for referral will be recorded and reported.
|
Within 1 year of the baseline visit
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Confirmed diagnosis of advanced liver fibrosis
Time Frame: Within 1 year of the baseline visit
|
The proportion of patients confirmed to have advanced fibrosis.
In this study, a patient is considered to have confirmed advanced fibrosis if (1) liver stiffness measurement by transient elastography is >15 kPa, (2) a liver biopsy shows bridging fibrosis (F3) or cirrhosis (F4), (3) unequivocal radiological features of cirrhosis (cirrhosis with nodular appearance, splenomegaly, ascites or varices), or (4) clinical, radiological or endoscopic evidence of portal hypertension.
In case of discrepant results, liver biopsy and unequivocal evidence of cirrhosis and/or portal hypertension will override the liver stiffness measurement results.
|
Within 1 year of the baseline visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent Wong, MD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAFLD-NIT-RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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