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. Participants will complete PROs pre-, mid-, and post- intervention and salivary cortisol pre-post intervention. Mediators will be measured after each session. This R21provides the investigators the necessary time and resources to thoroughly evaluate, de-bug, and refine all aspects of the intervention and study design in preparation for an efficient, rigorous and successful efficacy trial.
PROJECT RELEVANCE Chronic hepatitis C viral (HCV) infection is a multi-faceted systemic disease that can lead to cirrhosis, liver cancer, extra-hepatic disorders (EHDs), somatic and neuropsychiatric symptoms, and poor quality of life, coupled with multiple comorbidities, life stress, and unhealthy lifestyle behaviors, all of which coalesce into tremendous patient and public health burden. This pilot feasibility study of a small randomized controlled trial will evaluate a group-based stress management, coping skills, and lifestyle intervention tailored for patients with symptomatic chronic HCV delivered via multipoint videoconferencing technology to evaluate feasibility, patient acceptability, and improvements in several subjective and objective patient outcomes. If successful, these pilot data will be used to support a future efficacy trial of the VC-CBCS which has the potential to substantially decrease barriers to care, increase access to an effective intervention, and improve multiple patient outcomes.
