Flicker App for Minimal Hepatic Encephalopathy

• Conditions: Hepatic Encephalopathy

• Registration Number: NCT04415294
• Lead Sponsor: University of Washington

Brief Summary

There is a great unmet clinical need for improved screening for MHE in patients with cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize the protocol, software, and hardware of the Flicker-App to create a product appropriate for production and distribution to patients

Detailed Description

SA 1. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App in clinic supervised by a research assistant and calculate the level of agreement between the CFF determined by the Flicker-App, the CFF determined by the "gold-standard" FFS device, and the test scores on the EncephalApp Stroop test.

SA 2. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App at home, including daily measurements over 1 week and weekly measurements over 6 weeks, and calculate the adherence to this protocol and the variability of these CFF measurements.

SA3. Make any necessary software or hardware adjustments to the Flicker-App to facilitate and simplify its self-administration by patients based on structured interview-questionnaires with the study participants and with clinical Gastroenterologists/Hepatologists

Study Timeline

• Study Start: 2019-10-22
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Cirrhosis (standard criteria)
• Chronic liver disease

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Exclusion Criteria

• Grade III or IV hepatic encephalopathy
• Mini-mental state examination score ≤25 (suggestive of dementia)
• alcohol or illicit drug use within 3 months
• current use of benzodiazepines
• antiepileptics or psychotropic drugs
• color blindness
• severe vision impairment (blindness, macular degeneration).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CFF Agreement	1 day	Level of agreement between Flicker App CFF and gold-standard device

Trial Locations

Locations (1)

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States