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

NCT04198584 | Completed Results

• 2 other identifiers: 19-21971R21NR017908-01A1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (13)

• Percentage of Patients Consented Versus Approached

  One feasibility measure was to evaluate the percentage of patients consented compared to those approached for participation in the study.

  Six Months

• Percentage of Participants Consented Versus Randomized

  One feasibility measure was to evaluate the percentage of participants randomized for the study compared to those consented.

  Six Months

• Percentage of Standard of Care Condition Participants Retained vs Enrolled

  Percentage of standard of care condition participants retained in the study compared to those enrolled. Retention is defined as participants who submitted PRO assessments up through T4 (end of study).

  Six Months

• Percentage of VC-CBCS Intervention Condition Participants Retained vs Enrolled

  Percentage of VC-CBCS Intervention participants retained in the study compared to those enrolled. Retention is defined as participants who completed at least 3 intervention sessions.

  Six Months

• Percentage of Surveys Completed by Participants Who Completed the Study

  Percentage of surveys over time completed by participants who completed the study. Surveys included 12 patient-reported primary and secondary outcome measures. Completion was defined as submission of each of the 12 surveys at Time 1 (T1) through Time 4 (T4).

  Baseline (T1) to Week 14 (T4)

• Global Health Status Physical Health Mean T-Score

  The Patient Reported Outcome Measurement Information System (PROMIS) Global Health Status measure is a 10-item short form that was used to measure an individual's physical, mental, and social health. Item responses range from 5 = None to 1 = Very Severe. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 16.2 to 67.7. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation better (more healthy) than the general population.

  Baseline (T1), Week 14 (T4)

• Global Health Status Mental Health Mean T-Score

  The PROMIS Global Health Status measure is a 10-item short form that was used to measure an individual's physical, mental, and social health. Item responses range from 5 = None to 1 = Very Severe. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 21.2 to 67.7. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation better (more healthy) than the general population.

  Baseline (T1), Week 14 (T4)

• Depression Mean T-score

  The PROMIS Depression measure is an 8-item short form that was used to measure patient-reported depression. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 41.0 to 79.4. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more (more Depression) than the general population.

  Baseline (T1), Week 14 (T4)

• Anger Mean T-score

  The PROMIS Anger measure is a 5-item short form that was used to measure patient-reported anger. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 32.9 to 82.9. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Anger and T-score=40 is 1 standard deviation less Anger than the general population.

  Baseline (T1), Week 14 (T4)

• Anxiety Mean T-score

  The PROMIS Anxiety measure is a 4-item short form that was used to measure patient-reported anxiety. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 40.3 to 81.6. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Anxiety and T-score=40 is 1 standard deviation less Anxiety than the general population. The Anxiety T-score can range from 40.3 - 81.6.

  Baseline (T1), Week 14 (T4)

• Fatigue Mean T-score

  The PROMIS Fatigue measure is a 7-item short form that was used to measure patient-reported fatigue. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 29.4 to 83.2. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Fatigue and T-score=40 is 1 standard deviation less Fatigue than the general population.

  Baseline (T1), Week 14 (T4)

• Sleep Disturbance Mean T-score

  The PROMIS Sleep Disturbance measure is an 8-item short form that was used to measure patient-reported sleep disturbance. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 32.0 to 73.3. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Sleep Disturbance and T-score=40 is 1 standard deviation less Sleep Disturbance than the general population.

  Baseline (T1), Week 14 (T4)

• Pain Interference Mean T-score

  The PROMIS Pain Interference measure is an 8-item short form that was used to measure patient-reported pain interference. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 41.6 to 75.6. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Pain Interference and T-score=40 is 1 standard deviation less Pain Interference than the general population.

  Baseline (T1), Week 14 (T4)

Secondary Outcomes (30)

• Perceived Stress Mean Score

  Baseline (T1), Week 14 (T4)

• Coping Skills Confidence Mean Score

  Baseline (T1), Week 14 (T4)

• Participant Satisfaction With VC-CBCS Intervention Mean Score

  Baseline (T1) to Week 14 (T4)

• Aspartate Aminotransferase (AST) Mean Score for Females

  Baseline (T1), Week 14 (T4)

• Aspartate Aminotransferase (AST) Mean Score for Males

  Baseline (T1), Week 14 (T4)

Other Outcomes (2)

• Salivary Cortisol Area Under the Curve With Respect to Ground (AUC-G)

  Baseline (T1), Week 14 (T4)

• Participant Satisfaction With VC-CBCS Telehealth Session Mean Score

  Baseline (T1) to Week 14 (T4)

Study Arms (2)

VC-CBCS Intervention

EXPERIMENTAL

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.

Behavioral: VC-CBCS

Standard of Care (SC)

NO INTERVENTION

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

Interventions

VC-CBCS 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.

VC-CBCS Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Duke University: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Donna Evon, PhD
• Organization: University of North Carolina at Chapel Hill

donna_evon@med.unc.edu

919-966-6732

Study Officials

• Donna M. Evon, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: April 10, 2020
• Primary Completion: January 12, 2021
• Study Completion: February 24, 2021
• Last Updated: October 24, 2022
• Results First Posted: February 4, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)