N/A N=32 Randomized Treatment

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

Chronic Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT04198584 ↗

Enrolled (actual)

Serious AEs

3.5%

Results posted

Feb 2022

Primary outcome: Primary: Percentage of Patients Consented Versus Approached — 74 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: VC-CBCS (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients Consented Versus Approached	74	—
PRIMARY Percentage of Participants Consented Versus Randomized	82	—
PRIMARY Percentage of Standard of Care Condition Participants Retained vs Enrolled	100	—
PRIMARY Percentage of VC-CBCS Intervention Condition Participants Retained vs Enrolled	79.2	—
PRIMARY Percentage of Surveys Completed by Participants Who Completed the Study	99.4	—
PRIMARY Global Health Status Physical Health Mean T-Score	45.7; 41.8; 46.0; 48	—
PRIMARY Global Health Status Mental Health Mean T-Score	46.7; 41.9; 49.3; 45.9	—
PRIMARY Depression Mean T-score	52.3; 51.6; 48.6; 49.0	—
PRIMARY Anger Mean T-score	51.0; 52.3; 46.5; 46.9	—
PRIMARY Anxiety Mean T-score	52.7; 57.7; 50.4; 51.2	—
PRIMARY Fatigue Mean T-score	51.9; 50.4; 48.6; 46.6	—
PRIMARY Sleep Disturbance Mean T-score	52.0; 50.8; 50.0; 46.0	—
PRIMARY Pain Interference Mean T-score	53.5; 55.8; 52.0; 54.6	—
SECONDARY Perceived Stress Mean Score	24.2; 23.9; 20.6; 21.8	—
SECONDARY Coping Skills Confidence Mean Score	2.18; 2.16; 2.74; 2.38	—
SECONDARY Participant Satisfaction With VC-CBCS Intervention Mean Score	4.23	—
SECONDARY Aspartate Aminotransferase (AST) Mean Score for Females	28.0; 23.0; 31.0	—
SECONDARY Aspartate Aminotransferase (AST) Mean Score for Males	34.7; 36.5; 30.0; 45.3	—
SECONDARY Alanine Aminotransferase (ALT) Mean Score for Females	22.0; 13.0; 28.3	—
SECONDARY Alanine Aminotransferase (ALT) Mean Score for Males	34.6; 33.0; 36.9; 28.0	—
SECONDARY Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Mean Score	1.32; 1.13; 1.05; 0.71	—
SECONDARY Percentage of Overall Medication Adherence	85.2; 96.9; 92.8; 89.8	—
SECONDARY Alcohol Total Mean Score	1.39; 0.13; 0.95; 0.25	—
SECONDARY Percentage of Participants Who Improved Fruit Consumption by One or More Categories	47.0; 43.0	—
SECONDARY Percentage of Participants Who Improved Vegetable Consumption by One or More Categories	16; 14	—
SECONDARY Percentage of Participants Who Complete Moderate Activity for at Least 10 Minutes at a Time	73.7; 50.0; 78.9; 87.5	—
SECONDARY Mean Number of Minutes of Moderate Activity Per Week	314; 87.9; 528; 170	—
SECONDARY Percentage of Participants Who Complete Vigorous Activity for at Least 10 Minutes at a Time	42.1; 50.0; 47.4; 25.0	—
SECONDARY Mean Number of Minutes of Vigorous Activity Per Week	241; 55.7; 235; 17.1	—
SECONDARY Mean Time Spent Sitting on the Weekdays	8.95; 6.57; 7.0; 7.0	—
SECONDARY Mean Time Spent Sitting on the Weekends	7.68; 6.0; 4.22; 6.43	—
SECONDARY Percentage of Participants Who Reduced Regular Soda Intake by One or More Categories	35; 14	—
SECONDARY Percentage of Participants Who Reduced Diet Soda Intake by One or More Categories	5; 17	—
SECONDARY Percentage of Participants Who Reduced Fruit Juice Intake by One or More Categories	16; 29	—
SECONDARY Percentage of Participants Who Reduced Meals From Fast Food Restaurants by One or More Categories	39; 17	—
SECONDARY Percentage of Participants Who Increased Dinners Prepared at Home by 1 or More Days	35; 0	—
SECONDARY Change in Weight (Lbs)	-2.67; 0.0	—
SECONDARY Change in Percent Weight Change	0.91; -0.23	—
SECONDARY Change in Body Mass Index (BMI)	-0.53; 0.23	—
SECONDARY Prescription Drug Misuse Total Mean Score	0.11; 0.0; 0.11; 0.0	—
SECONDARY Non-prescription Street Drug Use Total Mean Score	1.37; 0.88; 0.95; 0.13	—
SECONDARY Pittsburgh Sleep Quality Index (PSQI) Sleep Efficiency Composite Mean Score	1.05; 1.38; 1.26; 0.75	—
SECONDARY Healthy Sleep Behaviors Mean Score	1.37; 2.13; 2.42; 2.17	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04198584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.