Trial Outcomes & Findings for Study of Telemedicine Stress Management and Lifestyle Group Intervention for HCV Patients (NCT NCT04198584)

NCT ID: NCT04198584

Last Updated: 2022-10-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: Six Months
• Results posted on: 2022-10-24

Participant Flow

53 participants were approached for study interest; 39 were consented and of those 32 were enrolled.

Participant milestones

Measure	VC-CBCS Intervention The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that include 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.	Standard of Care (SC) Participants randomized to Standard of Care (SC) received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians discretion.
Overall Study STARTED	24	8
Overall Study Randomized to Wave 1	5	2
Overall Study Randomized to Wave 2	7	2
Overall Study Randomized to Wave 3	6	2
Overall Study Randomized to Wave 4	6	2
Overall Study Total Randomized	24	8
Overall Study Actually Received Treatment	21	8
Overall Study COMPLETED	19	8
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	VC-CBCS Intervention n=24 Participants The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that included 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.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians discretion.	Total n=32 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 7.5 • n=5 Participants	56 years STANDARD_DEVIATION 11.4 • n=7 Participants	56 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	5 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants	8 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Six Months

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

Outcome measures

Measure	All Patients n=53 Participants All patients who were approached for the study.	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. Participants completed survey assessments four times during the study.
Percentage of Patients Consented Versus Approached	74 percentage of participants	—

PRIMARY outcome

Timeframe: Six Months

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

Outcome measures

Measure	All Patients n=39 Participants All patients who were approached for the study.	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. Participants completed survey assessments four times during the study.
Percentage of Participants Consented Versus Randomized	82 percentage of participants	—

PRIMARY outcome

Timeframe: Six Months

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).

Outcome measures

Measure	All Patients n=8 Participants All patients who were approached for the study.	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. Participants completed survey assessments four times during the study.
Percentage of Standard of Care Condition Participants Retained vs Enrolled	100 percentage of participants	—

PRIMARY outcome

Timeframe: Six Months

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.

Outcome measures

Measure	All Patients n=24 Participants All patients who were approached for the study.	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. Participants completed survey assessments four times during the study.
Percentage of VC-CBCS Intervention Condition Participants Retained vs Enrolled	79.2 percentage of participants	—

PRIMARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: Data collection rate is for those who completed the study - 8 Standard of Care and 19 VC-CBCS, total of 27 participants.

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).

Outcome measures

Measure	All Patients n=27 Participants All patients who were approached for the study.	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. Participants completed survey assessments four times during the study.
Percentage of Surveys Completed by Participants Who Completed the Study	99.4 percentage of surveys completed	—

PRIMARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

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.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Global Health Status Physical Health Mean T-Score Baseline (T1)	45.7 T-score Interval 27.3 to 64.1	41.8 T-score Interval 27.2 to 56.4
Global Health Status Physical Health Mean T-Score Week 14 (T4)	46.0 T-score Interval 31.7 to 60.3	48 T-score Interval 31.5 to 64.5

PRIMARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

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.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Global Health Status Mental Health Mean T-Score Baseline (T1)	46.7 T-score Interval 27.7 to 65.7	41.9 T-score Interval 26.0 to 57.8
Global Health Status Mental Health Mean T-Score Week 14 (T4)	49.3 T-score Interval 34.6 to 64.0	45.9 T-score Interval 31.0 to 60.8

PRIMARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

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.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Depression Mean T-score Baseline (T1)	52.3 T-score Interval 35.2 to 69.4	51.6 T-score Interval 31.0 to 72.2
Depression Mean T-score Week 14 (T4)	48.6 T-score Interval 35.1 to 62.1	49.0 T-score Interval 33.0 to 65.0

PRIMARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

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.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Anger Mean T-score Baseline (T1)	51.0 T-score Interval 31.8 to 70.2	52.3 T-score Interval 31.3 to 73.3
Anger Mean T-score Week 14 (T4)	46.5 T-score Interval 30.8 to 62.2	46.9 T-score Interval 26.8 to 67.0

PRIMARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

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.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Anxiety Mean T-score Baseline (T1)	52.7 T-score Interval 33.9 to 71.5	57.7 T-score Interval 42.0 to 73.4
Anxiety Mean T-score Week 14 (T4)	50.4 T-score Interval 34.7 to 66.1	51.2 T-score Interval 34.6 to 67.8

PRIMARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

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.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Fatigue Mean T-score Baseline (T1)	51.9 T-score Interval 30.4 to 73.4	50.4 T-score Interval 30.5 to 70.3
Fatigue Mean T-score Week 14 (T4)	48.6 T-score Interval 29.9 to 67.3	46.6 T-score Interval 26.6 to 66.6

PRIMARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

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.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Sleep Disturbance Mean T-score Baseline (T1)	52.0 T-score Interval 33.4 to 70.6	50.8 T-score Interval 37.6 to 64.0
Sleep Disturbance Mean T-score Week 14 (T4)	50.0 T-score Interval 36.6 to 63.4	46.0 T-score Interval 26.6 to 65.4

PRIMARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

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.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Pain Interference Mean T-score Baseline (T1)	53.5 T-score Interval 37.0 to 70.0	55.8 T-score Interval 39.9 to 71.7
Pain Interference Mean T-score Week 14 (T4)	52.0 T-score Interval 34.6 to 69.4	54.6 T-score Interval 37.5 to 71.7

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

The Perceived Stress Scale (PSS) is a widely used survey to measure stress perception. The scale includes 10 items, rated using a 5-point scale, from 0 (never) to 4 (very often) where patients report the frequency of stress symptoms in the past month. Items are summed with a minimum and maximum ranging from 0 to 40. Higher PSS scores reflect higher subjective stress.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Perceived Stress Mean Score Baseline (T1)	24.2 score on a scale Interval 20.8 to 27.7	23.9 score on a scale Interval 18.9 to 28.9
Perceived Stress Mean Score Week 14 (T4)	20.6 score on a scale Interval 17.9 to 23.4	21.8 score on a scale Interval 16.1 to 27.4

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

The Measure of Current Status (MOCS)-Part A measured participant confidence in performing multiple skills including stress awareness, relaxation, assertiveness, and coping skills. The scale contains 13 items rated on a scale from 0 = I cannot do this at all to 4 = I can do this extremely well. A Total Coping Skills score is created by taking the average of the 13 items. The Total Coping Skill score can range from a minimum of 0 to a maximum of 4.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Coping Skills Confidence Mean Score Baseline (T1)	2.18 score on a scale Interval 1.8 to 2.6	2.16 score on a scale Interval 1.7 to 2.6
Coping Skills Confidence Mean Score Week 14 (T4)	2.74 score on a scale Interval 2.4 to 3.1	2.38 score on a scale Interval 1.9 to 2.9

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: Participants randomized to Standard of Care received no intervention and did not complete survey.

After each VC-CBCS intervention session, participants completed a 14-item acceptability/satisfaction survey about their impressions with the current intervention session. Items are scored on a scale from 1= not at all to 5=extremely useful. Data across all VC-CBCS participants and all intervention sessions were averaged into a Total Patient Satisfaction score that could range from a minimum of 1 to a maximum of 5 with higher scores indicating greater satisfaction.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	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. Participants completed survey assessments four times during the study.
Participant Satisfaction With VC-CBCS Intervention Mean Score	4.23 score on a scale Standard Deviation 0.5	—

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: The analytic sample includes 4 females who completed the VC-CBCS intervention and 3 females in Standard of Care. Of these, 1 VC-CBCS Intervention participant had missing data at T4. Of the 3 females in Standard of Care, 2 had missing data at T1 and all 3 participants had missing data at T4.

Liver enzyme level (AST U/L). Reference range for females is 14-38 U/L. Numbers higher than these reference ranges are considered in the abnormal range and can suggest liver damage or inflammation. These comparisons were only made for participants who had already achieved viral cure at baseline and who were not on medical treatment for chronic hepatitis C at baseline.

Outcome measures

Measure	All Patients n=4 Participants All patients who were approached for the study.	Standard of Care (SC) n=1 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Aspartate Aminotransferase (AST) Mean Score for Females Baseline (T1)	28.0 U/L Standard Deviation 8.91	23.0 U/L Standard Deviation 0.0
Aspartate Aminotransferase (AST) Mean Score for Females Week 14 (T4)	31.0 U/L Standard Deviation 8.89	—

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: The analytic sample includes 14 males who completed the VC-CBCS intervention and 5 males in Standard of Care. Of these, 4 VC-CBCS Intervention participants had missing data at T1 and 5 at T4. Of the 5 males in Standard of Care, 1 had missing data at T1 and 2 had missing data at T4.

Liver enzyme level (AST U/L). Reference range for males is 19-55 U/L. Numbers higher than these reference ranges are considered in the abnormal range and can suggest liver damage or inflammation. These comparisons were only made for participants who had already achieved viral cure at baseline and who were not on Hepatitis C Virus (HCV) treatment at baseline.

Outcome measures

Measure	All Patients n=11 Participants All patients who were approached for the study.	Standard of Care (SC) n=4 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Aspartate Aminotransferase (AST) Mean Score for Males Baseline (T1)	34.7 U/L Standard Deviation 11.2	36.5 U/L Standard Deviation 17.3
Aspartate Aminotransferase (AST) Mean Score for Males Week 14 (T4)	30.0 U/L Standard Deviation 8.39	45.3 U/L Standard Deviation 31.8

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: The analytic sample includes 4 females who completed the VC-CBCS intervention and 3 females in Standard of Care. Of these, 1 VC-CBCS Intervention participant had missing data at T4. Of the 3 females in Standard of Care, 2 had missing data at T1 and all 3 participants had missing data at T4.

Liver enzyme level (ALT U/L). Reference range for females is <35 U/L. Numbers higher than these reference ranges are considered in the abnormal range and can suggest liver damage or inflammation. These comparisons were only made for participants who had already achieved viral cure at baseline and who were not on HCV treatment at baseline.

Outcome measures

Measure	All Patients n=4 Participants All patients who were approached for the study.	Standard of Care (SC) n=1 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Alanine Aminotransferase (ALT) Mean Score for Females Baseline (T1)	22.0 U/L Standard Deviation 13.0	13.0 U/L Standard Deviation 0.0
Alanine Aminotransferase (ALT) Mean Score for Females Week 14 (T4)	28.3 U/L Standard Deviation 20.0	—

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: The analytic sample includes 14 males who completed the VC-CBCS intervention and 5 males in Standard of Care. Of these, 4 VC-CBCS Intervention participants had missing data at T1 and 5 at T4. Of the 5 males in Standard of Care, 1 had missing data at T1 and 2 had missing data at T4.

Liver enzyme level (ALT U/L). Reference range for males is <50 U/L. Numbers higher than these reference ranges are considered in the abnormal range and can suggest liver damage or inflammation. These comparisons were only made for participants who had already achieved viral cure at baseline and who were not on HCV treatment at baseline.

Outcome measures

Measure	All Patients n=11 Participants All patients who were approached for the study.	Standard of Care (SC) n=4 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Alanine Aminotransferase (ALT) Mean Score for Males Baseline (T1)	34.6 U/L Standard Deviation 23.0	33.0 U/L Standard Deviation 10.3
Alanine Aminotransferase (ALT) Mean Score for Males Week 14 (T4)	36.9 U/L Standard Deviation 24.1	28.0 U/L Standard Deviation 12.5

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: 1 Standard of Care participant missing data for this variable at T4

Item 9 from the Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality. All participants completed this measure at PRO time points T1 and T4 that covered 30 days prior to assessment. "During the past month, how would you rate your sleep quality overall?" The response set ranged from a minimum of 0 (Very Good) to a maximum of 3 (Very Bad). Higher scores indicated worse sleep quality.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Mean Score Baseline (T1)	1.32 score on a scale Standard Deviation 0.82	1.13 score on a scale Standard Deviation 0.64
Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Mean Score Week 14 (T4)	1.05 score on a scale Standard Deviation 0.52	0.71 score on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: 7 VC-CBCS Intervention participants were excluded from the analysis because they were not prescribed daily medications at Baseline (T1). Two of the 12 VC-CBCS participants and 4 of the Standard of Care participants were missing data for this variable at T4.

Medication Adherence Visual Analog Scales (VAS) was used to evaluate medication adherence for up to five daily medications for multiple comorbidities in the past 7 days in participants who were prescribed medications at baseline. Participants reported the average adherence over the course of 7 days for each medication on a scale from 0% to 100% adherence for each medication. The average percent adherence was created for all medications for each patient and could range from 0% to 100%. Overall medication adherence adherence was assessed at T1 and T4.

Outcome measures

Measure	All Patients n=12 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Overall Medication Adherence Baseline (T1)	85.2 percentage of medication adherence Interval 73.9 to 96.5	96.9 percentage of medication adherence Interval 94.7 to 99.1
Percentage of Overall Medication Adherence Week 14 (T4)	92.8 percentage of medication adherence Interval 85.4 to 100.3	89.8 percentage of medication adherence Interval 72.6 to 106.9

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: 1 VC-CBCS Intervention participant with missing data at T1.

Three items from the Substance Abuse and Mental Illness Symptoms Screener (SAMISS) Survey was administered at baseline (T1) and Week 14 (T4) to evaluate self-reported alcohol use in all participants. The three items evaluated frequency, amount of alcohol consumption, and binge drinking. Individual scores could range from 0 to 4, with higher scores indicating higher consumption.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Alcohol Total Mean Score Baseline (T1)	1.39 score on a scale Standard Deviation 2.43	0.13 score on a scale Standard Deviation 0.35
Alcohol Total Mean Score Week 14 (T4)	0.95 score on a scale Standard Deviation 2.27	0.25 score on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: 1 Standard of Care participant missing data for this variable

Behavioral Risk Factor Surveillance System (BRFSS) items assessed fruit intake as a health behavior - "Over the past 12 months, how often did you eat fruits?" Original 8-point response scale ranged from "1 time per month" to "2 or more times/day." Recoded 8 categories into 4 categories, ranging from "Daily consumption" to "Less than weekly". The percentage shown is the number of participants who improved by 1 or more categories based on the 4 category levels from T1 to T4.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=7 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Participants Who Improved Fruit Consumption by One or More Categories	47.0 percentage of patients	43.0 percentage of patients

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: 1 Standard of Care participant missing data for this variable

Behavioral Risk Factor Surveillance System (BRFSS) items measured vegetable intake as a health behavior - "Over the past 12 months, how often did you eat vegetables?" Original 8-point response scale ranged from "1 time per month" to "2 or more times/day." Recoded 8 categories into 4 categories, ranging from "Daily consumption" to "Less than weekly". The percentage is the number of participants who improved by 1 or more categories on the 4 category levels from T1 to T4.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=7 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Participants Who Improved Vegetable Consumption by One or More Categories	16 percentage of participants	14 percentage of participants

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: 1 VC-CBCS Intervention participant with missing data at T1.

Behavioral Risk Factor Surveillance System (BRFSS) items measured moderate activity as a health behavior in all participants at T1 (baseline) and T4 (week 14) and will cover 30 days prior to assessment. BRFSS item asks "Do you do moderate activity for at least 10 minutes at a time"? Response options: Yes/No. Percentage is participants who indicate "Yes" to doing moderate activity for at least 10 minutes at a time

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Participants Who Complete Moderate Activity for at Least 10 Minutes at a Time Baseline (T1)	73.7 percentage of participants	50.0 percentage of participants
Percentage of Participants Who Complete Moderate Activity for at Least 10 Minutes at a Time Week 14 (T4)	78.9 percentage of participants	87.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline (T1) , Week 14 (T4)

Population: 5 participants with missing data for this variable (4 VC-CBCS intervention participants, 1 Standard of Care)

Behavioral Risk Factor Surveillance System (BRFSS) items measured moderate activity as a health behavior by combining two BRFSS items: "If yes, how many days per week do you do these moderate activities for at least 10 minutes at a time" and "If yes, how much total time per day do you spend doing these activities?" Total number of minutes of moderate activity per week calculated as number of days x number of minutes.

Outcome measures

Measure	All Patients n=15 Participants All patients who were approached for the study.	Standard of Care (SC) n=7 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Mean Number of Minutes of Moderate Activity Per Week Baseline (T1)	314 minutes Standard Deviation 556	87.9 minutes Standard Deviation 120
Mean Number of Minutes of Moderate Activity Per Week Week 14 (T4)	528 minutes Standard Deviation 808	170 minutes Standard Deviation 257

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: 1 VC-CBCS Intervention participant missing data for this variable

Behavioral Risk Factor Surveillance System (BRFSS) items measured vigorous activity as a health behavior - BRFSS Item "Do you do vigorous activity for at least 10 minutes at a time?" Response option: Yes/No. Percentage is participants who indicate "Yes" to doing vigorous activity for at least 10 minutes at a time

Outcome measures

Measure	All Patients n=18 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Participants Who Complete Vigorous Activity for at Least 10 Minutes at a Time Baseline (T1)	42.1 percentage of participants	50.0 percentage of participants
Percentage of Participants Who Complete Vigorous Activity for at Least 10 Minutes at a Time Week 14 (T4)	47.4 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: 2 participants missing data for this variable (1 VC-CBCS Intervention, 1 Standard of Care)

Behavioral Risk Factor Surveillance System (BRFSS) items measured vigorous activity as a health behavior by combining two BRFSS items: "If yes, How many days per week do you do these vigorous activities for at least 10 minutes at a time" and "If yes, how much total time per day do you spend doing these activities?" Total number of minutes of vigorous activity per week calculated as number of days x number of minutes.

Outcome measures

Measure	All Patients n=18 Participants All patients who were approached for the study.	Standard of Care (SC) n=7 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Mean Number of Minutes of Vigorous Activity Per Week Week 14 (T4)	235 total minutes in a week Standard Deviation 513	17.1 total minutes in a week Standard Deviation 34.0
Mean Number of Minutes of Vigorous Activity Per Week Baseline (T1)	241 total minutes in a week Standard Deviation 457	55.7 total minutes in a week Standard Deviation 74.4

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: 1 Standard of Care participant missing data for this variable

Behavioral Risk Factor Surveillance System (BRFSS) items measured sedentarism as a health behavior - BRFSS item "What is the total number of hours you spend siting on a weekday?" The mean can range from a minimum of 0 to maximum of 24 hours. Average numbers of hours spent sitting on the weekday was assessed at T1 to T4.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=7 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Mean Time Spent Sitting on the Weekdays Baseline (T1)	8.95 hours Standard Deviation 3.44	6.57 hours Standard Deviation 4.08
Mean Time Spent Sitting on the Weekdays Week 14 (T4)	7.0 hours Standard Deviation 2.28	7.0 hours Standard Deviation 2.31

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Behavioral Risk Factor Surveillance System (BRFSS) items measured sedentarism as a health behavior - BRFSS Item "What is the total number of hours you spend sitting on a weekend day?" Mean ranges from a minimum of 0 to maximum of 24 hours. Average numbers of hours spent sitting on the weekends assessed at T1 and T4.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Mean Time Spent Sitting on the Weekends Week 14 (T4)	4.22 hours Standard Deviation 2.26	6.43 hours Standard Deviation 3.10
Mean Time Spent Sitting on the Weekends Baseline (T1)	7.68 hours Standard Deviation 3.53	6.0 hours Standard Deviation 3.66

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: 3 participants missing data for this variable (2 VC-CBCS Intervention participants, 1 Standard of Care participant)

Behavioral Risk Factor Surveillance System (BRFSS) items measured soda intake as a health behavior - BRFSS item "During the past 30 days, how often did you drink regular soda or pop that contains sugar? Do not include diet soda or diet pop." Original 9-point response scale ranged from "Never" to "6 more more per day." Recoded 9 categories into 5 categories, ranging from "Never" to Daily." The percentage is the number of participants who improved (consumed less) by 1 or more categories on the 5 category levels from T1 to T4.

Outcome measures

Measure	All Patients n=17 Participants All patients who were approached for the study.	Standard of Care (SC) n=7 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Participants Who Reduced Regular Soda Intake by One or More Categories	35 percentage of participants	14 percentage of participants

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: 2 Standard of Care participants missing data for this variable

Behavioral Risk Factor Surveillance System (BRFSS) items measured diet soda intake as a health behavior - BRFSS item "During the past 30 days, how often did you drink diet soda or diet pop that contains an artificial sweeter?" Original 9-point response scale ranged from "Never" to "6 or more per day." Recoded 9 categories into 5, ranging from "Never" to Daily." The percentage is the number of patients who improved (consumed less) by 1 or more categories on the 5 recoded category level from T1 to T4.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=6 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Participants Who Reduced Diet Soda Intake by One or More Categories	5 percentage of participants	17 percentage of participants

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: 1 Standard of Care participant missing data for this variable

Behavioral Risk Factor Surveillance System (BRFSS) items measured fruit juice intake as a health behavior - BRFSS item "During the past month, how many times per day, week or month did you drink 100% pure fruit juices? Original 9-point response scale ranged from "Never" to "6 or more per day." Recoded 9 categories into 5, ranging from "Never" to Daily." The percentage is the number of participants who improved (consumed less) by 1 or more categories on the 5 recoded category levels from T1 to T4.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=7 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Participants Who Reduced Fruit Juice Intake by One or More Categories	16 percentage of participants	29 percentage of participants

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: 3 participants were missing data for this variable (1 VC-CBCS Intervention participant, 2 Standard of Care participants)

Behavioral Risk Factor Surveillance System (BRFSS) items measured fast food intake as a health behavior - BRFSS item "In a typical week, how many of your own meals come from fast food restaurants?" Original 9-point response scale ranged from "Never" to "6 or more per day." Recoded 9 categories into 5, ranging from "Never" to Daily." The percentage is the number of participants who improved (reduced) by 1 or more categories on the 5 recoded category levels from T1 to T4.

Outcome measures

Measure	All Patients n=18 Participants All patients who were approached for the study.	Standard of Care (SC) n=6 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Participants Who Reduced Meals From Fast Food Restaurants by One or More Categories	39 percentage of participants	17 percentage of participants

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: Three participants were missing data for this variable (2 VC-CBCS Intervention participants, 1 Standard of Care participant)

Behavioral Risk Factor Surveillance System (BRFSS) items measured food prepared at home as a health behavior - BRFSS item "On how many days per week do you usually eat a dinner that is prepared at home?" 7-point response scale ranged from 0 to 7 days. The percentage is the number of patients who improved (increased) by 1 or more days from T1 to T4.

Outcome measures

Measure	All Patients n=17 Participants All patients who were approached for the study.	Standard of Care (SC) n=7 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Percentage of Participants Who Increased Dinners Prepared at Home by 1 or More Days	35 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: 8 participants had missing data for this variable (4 VC-CBCS Intervention, 4 Standard of Care)

Change in weight (lbs) among those who had pre-intervention BMI > 24.9 (obese and above) from T1 to T4.

Outcome measures

Measure	All Patients n=15 Participants All patients who were approached for the study.	Standard of Care (SC) n=4 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Change in Weight (Lbs)	-2.67 pounds Standard Deviation 13.7	0.0 pounds Standard Deviation 3.56

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: 8 participants had missing data for this variable (4 VC-CBCS Intervention, 4 Standard of Care)

Change in percent weight (lbs) among those who had pre-intervention BMI > 24.9 (obese and above) from T1 to T4.

Outcome measures

Measure	All Patients n=15 Participants All patients who were approached for the study.	Standard of Care (SC) n=4 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Change in Percent Weight Change	0.91 percent of weight change Standard Deviation 5.65	-0.23 percent of weight change Standard Deviation 1.91

SECONDARY outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: 8 participants had missing data for this variable (4 VC-CBCS Intervention, 4 Standard of Care)

Change in Body Mass Index (BMI) among those who had pre-intervention BMI > 24.9 (obese and above) from T1 to T4.

Outcome measures

Measure	All Patients n=15 Participants All patients who were approached for the study.	Standard of Care (SC) n=4 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Change in Body Mass Index (BMI)	-0.53 kg/m^2 Standard Deviation 2.28	0.23 kg/m^2 Standard Deviation 0.83

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Surveys administered at baseline (T1) and Week 14 (T4) evaluated self-reported prescription drug misuse in all participants. One item from the Substance Abuse and Mental Illness Symptoms Screener (SAMISS) Survey evaluated misuse of prescription drugs in the last year. The response options ranged from a minimum of 0="Never" to a maximum of 4="Daily/Almost Daily". Higher scores indicate higher consumption.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Prescription Drug Misuse Total Mean Score Baseline (T1)	0.11 score on a scale Standard Deviation 0.32	0.0 score on a scale Standard Deviation 0.0
Prescription Drug Misuse Total Mean Score Week 14 (T4)	0.11 score on a scale Standard Deviation 0.32	0.0 score on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Surveys administered at baseline (T1) and Week 14 (T4) evaluated self-reported non-prescription street drug use in all participants. One item from the Substance Abuse and Mental Illness Symptoms Screener (SAMISS) Survey evaluated non-prescription street drug use in the last year. The response options ranged from a minimum of 0="Never" to a maximum of 4="Daily/Almost Daily". Higher scores indicate higher consumption.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Non-prescription Street Drug Use Total Mean Score Baseline (T1)	1.37 score on a scale Standard Deviation 1.71	0.88 score on a scale Standard Deviation 1.36
Non-prescription Street Drug Use Total Mean Score Week 14 (T4)	0.95 score on a scale Standard Deviation 1.47	0.13 score on a scale Standard Deviation 0.35

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Items 1, 3 and 4 from the Pittsburgh Sleep Quality Index (PSQI) were used to create a Sleep Efficiency composite score. All participants completed this measure at T1 and T4 that covered 30 days prior to assessment. The sleep efficiency score = (# hours slept/# hours in bed) X 100% .The sleep efficiency composite score ranged from: 0 = >85% efficiency,

1 = 75-84% efficiency, 2= 65-74% efficiency, and 3= <65%. Lower scores indicate better sleep efficiency.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Pittsburgh Sleep Quality Index (PSQI) Sleep Efficiency Composite Mean Score Baseline (T1)	1.05 score on a scale Standard Deviation 1.22	1.38 score on a scale Standard Deviation 1.30
Pittsburgh Sleep Quality Index (PSQI) Sleep Efficiency Composite Mean Score Week 14 (T4)	1.26 score on a scale Standard Deviation 1.37	0.75 score on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: 2 Standard of Care participants were missing data for this variable at T4

One item "In the last month, how often did you engage in healthy sleep behaviors before bedtime?" evaluated healthy sleep behaviors. All participants completed this measure at T1 and T4. The response set ranged from 0 (not at all) to 4 (almost every night). Higher scores indicated better sleep behaviors.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	Standard of Care (SC) n=8 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Healthy Sleep Behaviors Mean Score Baseline (T1)	1.37 score on a scale Standard Deviation 1.26	2.13 score on a scale Standard Deviation 0.99
Healthy Sleep Behaviors Mean Score Week 14 (T4)	2.42 score on a scale Standard Deviation 0.84	2.17 score on a scale Standard Deviation 1.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (T1), Week 14 (T4)

Population: T1: Data from 1 Standard of Care participant were excluded due to nontraditional sleep schedule. Data from 5 VC-CBCS Intervention participants were excluded due to missing data, nontraditional sleep schedules, and/or noncompliance with sample collection instructions. T4: Data from 2 Standard of Care participants and 7 VC-CBCS Intervention participants were excluded due to missing data, nontraditional sleep schedules, and/or noncompliance with sample collection instructions.

Participants in both conditions collected saliva samples at Baseline (T1) and Week 14 (T4). Participants were instructed to collect four saliva samples at each timepoint; 1) immediately upon awakening 2) 30 minutes after awakening 3) late afternoon 4) before bedtime. The mean AUC-G was then obtained at T1 and T4. Mean AUC-G scores could range from 0.195 to 2.29.

Outcome measures

Measure	All Patients n=14 Participants All patients who were approached for the study.	Standard of Care (SC) n=7 Participants Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians' discretion. Participants completed survey assessments four times during the study.
Salivary Cortisol Area Under the Curve With Respect to Ground (AUC-G) Baseline (T1)	1.01 ug/dL Standard Deviation 0.54	1.18 ug/dL Standard Deviation 0.65
Salivary Cortisol Area Under the Curve With Respect to Ground (AUC-G) Week 14 (T4)	0.71 ug/dL Standard Deviation 0.23	0.83 ug/dL Standard Deviation 0.46

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (T1) to Week 14 (T4)

Population: Participants randomized to Standard of Care received no intervention and did not complete survey.

After intervention week 1 and week 14, participants in the VC-CBCS intervention completed a 15-item acceptability/satisfaction survey about their satisfaction with using telehealth sessions. Items were scored on a scale from 1= strongly disagree to 5=strongly agree. The average Total Telehealth Satisfaction score from week 1 and week 14 was created, which ranged from 1 to 5 with higher scores indicating greater satisfaction. A previously developed Telehealth Patient Satisfaction Questionnaire was modified for this study.

Outcome measures

Measure	All Patients n=19 Participants All patients who were approached for the study.	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. Participants completed survey assessments four times during the study.
Participant Satisfaction With VC-CBCS Telehealth Session Mean Score Week 1	3.91 score on a scale Standard Deviation 0.68	—
Participant Satisfaction With VC-CBCS Telehealth Session Mean Score Week 14	4.5 score on a scale Standard Deviation 0.38	—

Adverse Events

VC-CBCS Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care (SC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	VC-CBCS Intervention n=21 participants at risk The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that included 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.	Standard of Care (SC) n=8 participants at risk Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians discretion.
Vascular disorders Transient Ischemic Attack (TIA)	4.8% 1/21 • Number of events 1 • From the time of first intervention session through the last intervention session, an approximate total of 14 weeks.	0.00% 0/8 • From the time of first intervention session through the last intervention session, an approximate total of 14 weeks.

Other adverse events

Adverse event data not reported

Additional Information

Donna Evon, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-6732

Email: donna_evon@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place