Clinical trial NCT04198584: Study of Telemedicine Stress Management and Lifestyle Group Intervention for HCV Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis C
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Duke University
name: National Institute of Nursing Research (NINR)
First posted: 2019-12-13
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants (n=32) were assigned by 3:1 randomization to VC-CBCS or SC. Participants were recruited in 4 cohorts (Wave 1: n=7, Wave 2: n=9, Waves 3, 4: n=8 each). In Wave 1, 5 participants were randomized to VC-CBCS and 2 to SC. In Wave 2, 7 participants were randomized to VC-CBCS and 2 to SC. In Waves 3 and 4, 6 participants were randomized to VC-CBCS and 2 to SC.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Patients Consented Versus Approached
timeFrame: Six Months
measure: Percentage of Participants Consented Versus Randomized
timeFrame: Six Months
measure: Percentage of Standard of Care Condition Participants Retained vs Enrolled
timeFrame: Six Months
measure: Percentage of VC-CBCS Intervention Condition Participants Retained vs Enrolled
timeFrame: Six Months
measure: Percentage of Surveys Completed by Participants Who Completed the Study
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Global Health Status Physical Health Mean T-Score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Global Health Status Mental Health Mean T-Score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Depression Mean T-score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Anger Mean T-score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Anxiety Mean T-score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Fatigue Mean T-score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Sleep Disturbance Mean T-score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Pain Interference Mean T-score
timeFrame: Baseline (T1), Week 14 (T4)
Secondary outcomes:
measure: Perceived Stress Mean Score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Coping Skills Confidence Mean Score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Participant Satisfaction With VC-CBCS Intervention Mean Score
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Aspartate Aminotransferase (AST) Mean Score for Females
timeFrame: Baseline (T1), Week 14 (T4)
measure: Aspartate Aminotransferase (AST) Mean Score for Males
timeFrame: Baseline (T1), Week 14 (T4)
measure: Alanine Aminotransferase (ALT) Mean Score for Females
timeFrame: Baseline (T1), Week 14 (T4)
measure: Alanine Aminotransferase (ALT) Mean Score for Males
timeFrame: Baseline (T1), Week 14 (T4)
measure: Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Mean Score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Percentage of Overall Medication Adherence
timeFrame: Baseline (T1), Week 14 (T4)
measure: Alcohol Total Mean Score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Percentage of Participants Who Improved Fruit Consumption by One or More Categories
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Percentage of Participants Who Improved Vegetable Consumption by One or More Categories
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Percentage of Participants Who Complete Moderate Activity for at Least 10 Minutes at a Time
timeFrame: Baseline (T1), Week 14 (T4)
measure: Mean Number of Minutes of Moderate Activity Per Week
timeFrame: Baseline (T1) , Week 14 (T4)
measure: Percentage of Participants Who Complete Vigorous Activity for at Least 10 Minutes at a Time
timeFrame: Baseline (T1), Week 14 (T4)
measure: Mean Number of Minutes of Vigorous Activity Per Week
timeFrame: Baseline (T1), Week 14 (T4)
measure: Mean Time Spent Sitting on the Weekdays
timeFrame: Baseline (T1), Week 14 (T4)
measure: Mean Time Spent Sitting on the Weekends
timeFrame: Baseline (T1), Week 14 (T4)
measure: Percentage of Participants Who Reduced Regular Soda Intake by One or More Categories
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Percentage of Participants Who Reduced Diet Soda Intake by One or More Categories
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Percentage of Participants Who Reduced Fruit Juice Intake by One or More Categories
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Percentage of Participants Who Reduced Meals From Fast Food Restaurants by One or More Categories
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Percentage of Participants Who Increased Dinners Prepared at Home by 1 or More Days
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Change in Weight (Lbs)
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Change in Percent Weight Change
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline (T1) to Week 14 (T4)
measure: Prescription Drug Misuse Total Mean Score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Non-prescription Street Drug Use Total Mean Score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Pittsburgh Sleep Quality Index (PSQI) Sleep Efficiency Composite Mean Score
timeFrame: Baseline (T1), Week 14 (T4)
measure: Healthy Sleep Behaviors Mean Score
timeFrame: Baseline (T1), Week 14 (T4)
Other outcomes:
measure: Salivary Cortisol Area Under the Curve With Respect to Ground (AUC-G)
timeFrame: Baseline (T1), Week 14 (T4)
measure: Participant Satisfaction With VC-CBCS Telehealth Session Mean Score
timeFrame: Baseline (T1) to Week 14 (T4)
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Donna M. Evon, PhD
role: PRINCIPAL_INVESTIGATOR
References: