# Optimizing Measures for Clinical Trials in Covert Hepatic Encephalopathy

> **NIH NIH K23** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2020 · $193,720

## Abstract

Optimizing Measures for Clinical Trials in Covert Hepatic Encephalopathy
PI: Elliot B. Tapper, MD
Among all complications of cirrhosis, none is more devastating than hepatic encephalopathy (HE). Although it
will afflict up to 40% of patients with cirrhosis, HE has few dedicated researchers. A spectrum of
neuropsychiatric disability, HE ranges in severity from covert (deficits in executive function) to overt (confusion,
even coma). Even covert HE – the earliest stage – is independently associated with repeated hospitalization,
falls, motor vehicle accidents and death. Unfortunately, strategies to prevent the development HE are limited.
Furthermore, investigations of potential therapies are complicated by limited knowledge of both the clinical
predictors of HE and impact on patient well-being and daily functions. This grant proposes to close these gaps.
The training program aims to prepare the applicant for a career vested in identifying risk factors for HE, and in
designing interventions to prevent HE and to improve patient well-being. A master's degree in clinical
investigation with targeted additional courses will provide training in clinical trial design, calibration of patient
reported measures for clinical trials, and longitudinal data analysis to develop clinical predictive models. The
mentorship team assembled is diverse and talented, including Dr. Anna Lok (a clinical trialist and content
expert), Dr. Jasmohan Bajaj (an authority on HE and clinical trials), Dr. Noelle Carlozzi (a neuropsychologist
with expertise in mixed-methodology), and Dr. Susan Murphy (a trialist with a focus on interventions for frail
patients). In research aim 1, we will determine the most important domains of health related quality of life
(HRQOL) for patients with covert HE. In Aim 2, we will analyze a cohort of 300 cirrhosis patients without HE
followed for up to 4 years to determine the modifiable risk factors for HE and to develop predictive models for
HE and falls. In Aim 3, we will launch a pilot intervention aimed at the improvement of HRQOL and prevention
of falls in patients with covert HE using a web-based platform that co-ordinates a combination of text-message,
email and interactive-voice response to deliver structured encouragement to meet nutritional and exercise
goals aimed at improving sarcopenia. By the conclusion of the K23, the applicant will be positioned for
academic success with a niche in an important complication of cirrhosis and providing necessary preliminary
data for an R01 supporting a larger, randomized trial.

## Key facts

- **NIH application ID:** 9853786
- **Project number:** 5K23DK117055-02
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Elliot Tapper
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $193,720
- **Award type:** 5
- **Project period:** 2019-07-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9853786

## Citation

> US National Institutes of Health, RePORTER application 9853786, Optimizing Measures for Clinical Trials in Covert Hepatic Encephalopathy (5K23DK117055-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9853786. Licensed CC0.

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