# Pilot feasibility testing of a small randomized controlled trial to evaluate a telemedicine stress management and lifestyle group intervention for patients with symptomatic chronic hepatitis C

> **NIH NIH R21** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $120,156

## Abstract

PROJECT SUMMARY
The overarching long-term goal of this scientific research program is to develop, test, and implement psychosocial
interventions to enhance the overall health and well-being of the chronic liver disease population using innovative
telehealth technology. The goal of these interventions is to provide secondary prevention health promotion strategies to
improve patient outcomes and prevent liver disease progression by targeting mechanisms associated with poor health.
Psychosocial interventions have demonstrated clinical efficacy in improving health outcomes in other chronic diseases,
but none have been developed for chronic liver disease. It behooves liver researchers to determine if similar health
benefits may be conferred on liver disease patients, particularly those who have been infected with chronic hepatitis C
virus (HCV) and who remain symptomatic and at-risk. Given significant barriers to care, telehealth interventions
delivered directly to patients in their homes are innovative, cost-efficient, scalable, and patient-centered options that
warrant investigation. During her NIDDK-funded career development award, the PI developed and evaluated an in-
person cognitive behavioral coping skills intervention (CBCS-HCV) with patients with HCV. Patient enthusiasm was
high and improvements in patient-reported outcomes (PROs) were observed; yet in-person sessions were impractical.
The current R21 application is a logical extension of this prior work. We propose a pilot feasibility study of a mini-
randomized controlled trial (RCT) to evaluate the CBCS delivered via multipoint videoconferencing technology (VC-
CBCS) to evaluate feasibility, patient acceptability, improvements in patient outcomes (health status, symptoms, liver
disease markers). In this pilot, a representative sample of 32 symptomatic patients who have been infected with HCV
will be randomized to VC-CBCS or standard of care (SC). Participants will be assigned by 3:1 randomization. We will
recruit patients in 4 cohorts of 8. Within each 8-patient cohort, 6 will be randomized to VC-CBCS and 2 to SC. The
specific aims are to evaluate: (1) the feasibility of conducting a RCT of the VC- CBCS; (2) the feasibility of
intervention delivery via VC; (3) patient acceptability; and (4) change in patient outcomes, mediators and intervention
targets, as well as temporal associations and strength of associations among variables in a preliminary conceptual
model. Patients will be recruited from a single liver center. Patients in the VC- CBCS will participate in 14 weekly
group sessions that provide didactic information, motivational enhancement, and practice of cognitive-behavioral skills,
stress management and lifestyle modification. Tentative mediators include psychological and physical stress, lifestyle
changes, medication adherence. Feasibility tests will examine the proportion of patients screened, recruited, retained;
sessions attended; missing data; and technical difficulties. Part...

## Key facts

- **NIH application ID:** 9928121
- **Project number:** 5R21NR017908-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Donna Marie Evon
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $120,156
- **Award type:** 5
- **Project period:** 2019-06-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9928121

## Citation

> US National Institutes of Health, RePORTER application 9928121, Pilot feasibility testing of a small randomized controlled trial to evaluate a telemedicine stress management and lifestyle group intervention for patients with symptomatic chronic hepatitis C (5R21NR017908-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9928121. Licensed CC0.

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