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

NCT ID: NCT04198584

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-10
• Study Completion Date: 2021-02-24

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VC-CBCS Intervention

The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that involved group-based psychoeducation, cognitive and behavioral skills training, stress management, relaxation practice and healthy lifestyle habits to support overall health and liver health. Intervention materials included a hard copy Patient Workbook and audio-recorded relaxation techniques.

Group Type: EXPERIMENTAL

VC-CBCS

Intervention Type: BEHAVIORAL

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.

Standard of Care (SC)

Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians discretion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 21 and older;
• Medically cleared by hepatology
• Patients who are currently or were previously diagnosed with chronic Hepatitis C Viral (HCV) infection;
• Evidence of ongoing symptoms, stress, or unhealthy lifestyle habits, defined as a score of greater than or equal to 4 on a scale 0(none) - 10 (severe) on two or more numeric rating scale questions (see Screening Form 1);
• Able to read and speak English.

Exclusion Criteria

• Decompensated liver disease (Childs Pugh C) judged by hepatologist or recorded in patient medical record;
• Life expectancy of <12 months estimated by hepatologist;
• Has had a liver transplant or is on the wait list for a transplant
• Severe alcohol or substance use disorder, psychiatric disorder or cognitive impairment that is likely to interfere with the ability to participate in telehealth groups and follow guidelines about group participation as judged by the Hepatology provider or research staff;
• Lack of private, quiet space in home in which to participate in VC-CBCS sessions
• Unwilling to have intervention sessions audio-recorded

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna M. Evon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21NR017908-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-2197

Identifier Type: -

Identifier Source: org_study_id