NCT04198584

Study of Telemedicine Stress Management and Lifestyle Group Intervention for HCV Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

A pilot feasibility study of a small randomized controlled trial (RCT) comparing a video-conferencing cognitive behavioral coping skills (VC-CBCS) group to standard of care (SC) for symptomatic patients previously diagnosed with chronic hepatitis C to evaluate feasibility, patient satisfaction and differences in symptoms, quality of life and liver markers.

Detailed description

This is a pilot feasibility study of a small randomized controlled trial (RCT) to evaluate a cognitive behavioral coping skills (CBCS) delivered via videoconferencing, referred to as the "VC-CBCS" compared to standard of care (SC). The study included a representative sample of 32 symptomatic patients who have/had chronic hepatitis C. Patients (n=32) were randomized in a 1:3 ratio to (1) standard of care (SC) or (2) to participate in 14, two hour VC-CBCS sessions. Four groups of patients were randomized and consisted of 7-9 patients each. The groups were as follows: * Group 1: 7 patients with 5 randomized to VC-CBCS and 2 to SC; * Group 2: 9 patients with 7 randomized to VC-CBCS and 2 to SC; * Groups 3 and 4: 8 patients each with 6 randomized to VC-CBCS and 2 to SC each group. Each wave of VC-CBCS patients formed a group to join the Group Facilitator via a WebEx platform on a weekly basis using iPads from their homes. The telehealth intervention provided group-based education, skills and practices involving stress management, coping with symptoms, and support for healthy lifestyle changes. The researchers examined: (1) the feasibility of delivering a group intervention via telehealth technology remotely using iPads, (2) participant satisfaction with the intervention, and (3) whether differences are observed in several outcomes between the two conditions on quality of life, physical and mental symptoms, and liver markers. Participants completed patient-reported outcome (PRO) surveys at four time points during the study, with main outcomes being change from pre-intervention to post-intervention.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
BEHAVIORAL	VC-CBCS	A 14-module stress management and lifestyle group-based intervention delivered via videoconferencing WebEx technology to participants who have/had chronic hepatitis C and experience symptoms, stress or lifestyle requirements to promote liver health.

Timeline

• Start date: 2020-04-10
• Primary completion: 2021-01-12
• Completion: 2021-02-24
• First posted: 2019-12-13
• Last updated: 2022-10-24
• Results posted: 2022-02-04

Locations

1 site across 1 country: United States