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Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C

Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01707030
Enrollment
138
Registered
2012-10-15
Start date
2015-03-01
Completion date
2018-06-29
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse, Hepatitis C

Keywords

clinical trial, veteran, substance use disorder

Brief summary

Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous for them than it is for a non-infected person. In this VA study, such individuals will be screened and given feedback on their drinking using an Internet-based program which has been shown to reduce drinking in other populations. The research team will evaluate whether the program helps Veterans drink less over time and thereby improve their health.

Detailed description

As many as 80% of Veterans with the hepatitis C virus (HCV) engage in harmful drinking. This is a major health challenge given that even light and moderate alcohol consumption can worsen the course and consequences of HCV and can be a barrier to receiving antiviral therapy. In response, the VA Uniform Mental Health Services Package has made it a priority that HCV and other ambulatory clinics provide evidence-based mental health services to all Veterans engaging in harmful drinking within two week (but preferably the same day as the clinic visit). The investigators' CREATE partners, the VA Office of Mental Health Services, VA Operations (10N), and the VA Office of Public Health, are strongly committed to achieving this standard throughout the Veterans Health Administration (VHA). However, the cost and organizational challenges to meeting this mandate in HCV clinics are enormous, but may be surmountable through the use of self-directed technology that minimizes demands on scarce staff time. The primary objective of this study is to implement and evaluate a web-based brief alcohol intervention (BAI) for treating Veterans with HCV and seeking care at two VA HCV clinics - Veterans Affairs Palo Alto Health Care System (VAPAHCS) and San Francisco Veterans Affairs Medical Center (SFVAMC). This study will have three aims: First (Aim 1), the investigators plan to assess patient, provider, and system factors that may impact the initial adoption of this intervention in two VA HCV clinics. These data will result in the development of a protocol for the initial implementation of the web-based BAI at the investigators' two study sites. A secondary aim will involve obtaining patient and provider feedback on an existing web-based BAI (see www.bmi-aft.org, VA Intranet Only) to help inform its redesign for use with this population. Second (Aim 2), the investigators will implement and examine the effectiveness of a web-based BAI in two HCV clinics to reduce alcohol consumption in Veterans with HCV at three- and six-months post-treatment. Third (Aim 3), the investigators will conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and the trajectory of health care spending for study participants. This mixed-methods study will utilize qualitative and quantitative methods to achieve its three primary aims. To address aim 1, qualitative interviews will be used to collect data that will inform the initial implementation and re-versioning of a web-based BAI for use in two HCV clinics located at the Palo Alto and San Francisco. To address aim 2, the investigators will use a randomized, hybrid (type 1) design with patient level clinical outcome data and formative evaluation data collected to examine the effectiveness of the web-based BAI. Hybrid designs also integrate formative evaluation into experimental designs to identify factors that impact the effectiveness of implementation efforts. Formative evaluation (e.g., site visits, clinic observation, and interviews with staff and patients) will be used to improve the adoption of the web-based BAI at both sites and to provide evidence-based guidance to the investigators' CREATE operational partners for nationwide implementation. To address aim 3, the investigators will conduct a budget impact analysis to estimate the short-term costs (1-3 years) of adoption and diffusion of the web-based BAI and the trajectory of health care spending for study participants. The investigators plan to collect several types of utilization data, including outpatient, inpatient, and pharmacy utilization, and calculate total dollars.

Interventions

OTHERWeb-Based Brief Alcohol Intervention

Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.

OTHERUsual Care

All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Must be a US military veteran. * Over the age of 17 with liver disease. * Must be receiving care at a VA liver clinic.

Exclusion criteria

* Those with no current or historical use of alcohol.

Design outcomes

Primary

MeasureTime frameDescription
Change in Drinking DaysBaseline, 3 months, and 6 monthsThe number of days on which alcohol was consumed at any level in the last 30 days.
Change in Days of Unhealthy Alcohol ConsumptionBaseline, 3 months, and 6 monthsThe number of days on which alcohol was consumed beyond recommended levels in the last 30 days.

Secondary

MeasureTime frameDescription
Change in Symptoms of Psychological Distress (PHQ-9)Baseline, 3 months, and 6 monthsSymptoms of psychological distress will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 provides an assessment of depression severity. The minimum value is 0 and the maximum value is 27. Lower scores are better. The reliability, validity, and clinical utility of the PHQ-9 instrument are well-established.
Change in Additional CareBaseline and 12 monthsTotal costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.
Change in SF-12 Physical Health CompositeBaseline, 3 months, and 6 monthsThe Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population . The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the physical health component of the SF-12. Scores range from 0-100 and higher scores are better.
Change in Drinks Per Drinking DayBaseline, 3 months, and 6 monthsThe number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.

Other

MeasureTime frameDescription
Change in SF-12 Mental Health CompositeBaseline, 3 months, and 6 monthsThe Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population. The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the mental health component of the SF-12. Scores range from 0-100 and higher scores are better.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention: Computer-Based Brief Alcohol Intervention
Receiving a web-based brief intervention for alcohol problems Web-Based Brief Alcohol Intervention: Participants report their alcohol use and problems on line and receive feedback comparing them to national norms. Intervention participants will also receive usual care. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.
67
Control: Treatment as Usual
In usual care, Hepatitis C clinic staff will sometimes discuss alcohol use with patients, and this will be the experience of some of the controls Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.
71
Total138

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath11
Overall StudyLost to Follow-up813
Overall StudyWithdrawal by Subject23

Baseline characteristics

CharacteristicIntervention: Computer-Based Brief Alcohol InterventionControl: Treatment as UsualTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
25 Participants31 Participants56 Participants
Age, Categorical
Between 18 and 65 years
42 Participants40 Participants82 Participants
Age, Continuous64 years
STANDARD_DEVIATION 8.682
63 years
STANDARD_DEVIATION 7.212
63.5 years
STANDARD_DEVIATION 8.023
Race/Ethnicity, Customized
Race/Ethnicity
American Indian or Alaskan Native
3 Participants0 Participants3 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Asian and/or Pacific Islander
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Black/African Amerian
21 Participants20 Participants41 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Declined to State/Unknown
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic
9 Participants15 Participants24 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other
6 Participants6 Participants12 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White/Caucasion, not of Hispanic origin
25 Participants28 Participants53 Participants
Region of Enrollment
United States
67 Participants71 Participants138 Participants
Sex: Female, Male
Female
5 Participants0 Participants5 Participants
Sex: Female, Male
Male
62 Participants71 Participants133 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 671 / 71
other
Total, other adverse events
0 / 670 / 71
serious
Total, serious adverse events
1 / 671 / 71

Outcome results

Primary

Change in Days of Unhealthy Alcohol Consumption

The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.

Time frame: Baseline, 3 months, and 6 months

Population: Not all participants were able to complete all follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.

ArmMeasureGroupValue (MEAN)Dispersion
BAI ArmChange in Days of Unhealthy Alcohol Consumption3-mo Days of Unhealthy Alcohol Consumption2.72 Unhealthy drinking days in last 30Standard Deviation 6.69
BAI ArmChange in Days of Unhealthy Alcohol ConsumptionBaseline Days of Unhealthy Alcohol Consumption5.46 Unhealthy drinking days in last 30Standard Deviation 9.24
BAI ArmChange in Days of Unhealthy Alcohol Consumption6-mo Days of Unhealthy Alcohol Consumption2.29 Unhealthy drinking days in last 30Standard Deviation 6.37
Usual CareChange in Days of Unhealthy Alcohol ConsumptionBaseline Days of Unhealthy Alcohol Consumption7.16 Unhealthy drinking days in last 30Standard Deviation 10.66
Usual CareChange in Days of Unhealthy Alcohol Consumption3-mo Days of Unhealthy Alcohol Consumption5.56 Unhealthy drinking days in last 30Standard Deviation 10.68
Usual CareChange in Days of Unhealthy Alcohol Consumption6-mo Days of Unhealthy Alcohol Consumption4.78 Unhealthy drinking days in last 30Standard Deviation 9.91
Primary

Change in Drinking Days

The number of days on which alcohol was consumed at any level in the last 30 days.

Time frame: Baseline, 3 months, and 6 months

Population: Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.

ArmMeasureGroupValue (MEAN)Dispersion
BAI ArmChange in Drinking DaysBaseline drinking days9.39 Number of drinking days in last 30Standard Deviation 10.44
BAI ArmChange in Drinking Days3-mo drinking days5.20 Number of drinking days in last 30Standard Deviation 8.09
BAI ArmChange in Drinking Days6-mo drinking days4.61 Number of drinking days in last 30Standard Deviation 7.66
Usual CareChange in Drinking DaysBaseline drinking days12.41 Number of drinking days in last 30Standard Deviation 11.47
Usual CareChange in Drinking Days3-mo drinking days7.77 Number of drinking days in last 30Standard Deviation 10.78
Usual CareChange in Drinking Days6-mo drinking days8.26 Number of drinking days in last 30Standard Deviation 10.67
Secondary

Change in Additional Care

Total costs in dollars of all VA and non-VA inpatient, outpatient and pharmacy costs.

Time frame: Baseline and 12 months

Population: These are the same individuals enrolled in the clinical trial from whom the primary outcomes were assessed.

ArmMeasureValue (MEAN)Dispersion
BAI ArmChange in Additional Care42412 US DollarsStandard Error 5381
Usual CareChange in Additional Care51667 US DollarsStandard Error 8611
Secondary

Change in Drinks Per Drinking Day

The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.

Time frame: Baseline, 3 months, and 6 months

Population: Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.

ArmMeasureGroupValue (MEAN)Dispersion
BAI ArmChange in Drinks Per Drinking DayBaseline Drinks per Drinking Day3.57 Drinks per Drinking DayStandard Deviation 3.9
BAI ArmChange in Drinks Per Drinking Day3-mo Drinks per Drinking Day2.29 Drinks per Drinking DayStandard Deviation 2.47
BAI ArmChange in Drinks Per Drinking Day6-mo Drinks per Drinking Day1.98 Drinks per Drinking DayStandard Deviation 2.85
Usual CareChange in Drinks Per Drinking DayBaseline Drinks per Drinking Day3.72 Drinks per Drinking DayStandard Deviation 3.69
Usual CareChange in Drinks Per Drinking Day3-mo Drinks per Drinking Day2.17 Drinks per Drinking DayStandard Deviation 2.17
Usual CareChange in Drinks Per Drinking Day6-mo Drinks per Drinking Day1.87 Drinks per Drinking DayStandard Deviation 1.9
Secondary

Change in SF-12 Physical Health Composite

The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population . The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the physical health component of the SF-12. Scores range from 0-100 and higher scores are better.

Time frame: Baseline, 3 months, and 6 months

Population: Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.

ArmMeasureGroupValue (MEAN)Dispersion
BAI ArmChange in SF-12 Physical Health CompositeBaseline SF-12 Health40.43 score on a scaleStandard Deviation 12.2
BAI ArmChange in SF-12 Physical Health Composite3mo SF-12 Health39.92 score on a scaleStandard Deviation 12.25
BAI ArmChange in SF-12 Physical Health Composite6mo SF-12 Health42.21 score on a scaleStandard Deviation 10.43
Usual CareChange in SF-12 Physical Health CompositeBaseline SF-12 Health40.49 score on a scaleStandard Deviation 11.43
Usual CareChange in SF-12 Physical Health Composite3mo SF-12 Health41.59 score on a scaleStandard Deviation 12.3
Usual CareChange in SF-12 Physical Health Composite6mo SF-12 Health40.75 score on a scaleStandard Deviation 12.45
Secondary

Change in Symptoms of Psychological Distress (PHQ-9)

Symptoms of psychological distress will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 provides an assessment of depression severity. The minimum value is 0 and the maximum value is 27. Lower scores are better. The reliability, validity, and clinical utility of the PHQ-9 instrument are well-established.

Time frame: Baseline, 3 months, and 6 months

Population: Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.

ArmMeasureGroupValue (MEAN)Dispersion
BAI ArmChange in Symptoms of Psychological Distress (PHQ-9)Baseline PHQ-96.00 score on a scaleStandard Deviation 5.7
BAI ArmChange in Symptoms of Psychological Distress (PHQ-9)3-mo PHQ-96.03 score on a scaleStandard Deviation 5.65
BAI ArmChange in Symptoms of Psychological Distress (PHQ-9)6-mo PHQ-95.57 score on a scaleStandard Deviation 5.07
Usual CareChange in Symptoms of Psychological Distress (PHQ-9)Baseline PHQ-96.68 score on a scaleStandard Deviation 5.67
Usual CareChange in Symptoms of Psychological Distress (PHQ-9)3-mo PHQ-96.91 score on a scaleStandard Deviation 6.86
Usual CareChange in Symptoms of Psychological Distress (PHQ-9)6-mo PHQ-97.44 score on a scaleStandard Deviation 7.48
Other Pre-specified

Change in SF-12 Mental Health Composite

The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population. The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the mental health component of the SF-12. Scores range from 0-100 and higher scores are better.

Time frame: Baseline, 3 months, and 6 months

Population: Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.

ArmMeasureGroupValue (MEAN)Dispersion
BAI ArmChange in SF-12 Mental Health CompositeBaseline SF-12 Mental Health49.10 score on a scaleStandard Deviation 12.72
BAI ArmChange in SF-12 Mental Health Composite3mo SF-12 Mental Health50.83 score on a scaleStandard Deviation 9.94
BAI ArmChange in SF-12 Mental Health Composite6 mo SF-12 Mental Health50.63 score on a scaleStandard Deviation 10.59
Usual CareChange in SF-12 Mental Health CompositeBaseline SF-12 Mental Health48.91 score on a scaleStandard Deviation 11.87
Usual CareChange in SF-12 Mental Health Composite3mo SF-12 Mental Health49.25 score on a scaleStandard Deviation 11.62
Usual CareChange in SF-12 Mental Health Composite6 mo SF-12 Mental Health48.51 score on a scaleStandard Deviation 12.77

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026