Trial Outcomes & Findings for Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C (NCT NCT01707030)

NCT ID: NCT01707030

Last Updated: 2025-03-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

138 participants

Primary outcome timeframe

Baseline, 3 months, and 6 months

Results posted on

2025-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Web-Based BAI Arm 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.	Usual Care Arm 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.
Overall Study STARTED	67	71
Overall Study COMPLETED	56	54
Overall Study NOT COMPLETED	11	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Web-Based BAI Arm 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.	Usual Care Arm 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.
Overall Study Death	1	1
Overall Study Withdrawal by Subject	2	3
Overall Study Lost to Follow-up	8	13

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention: Computer-Based Brief Alcohol Intervention n=67 Participants 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.	Control: Treatment as Usual n=71 Participants 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.	Total n=138 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	31 Participants n=7 Participants	56 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 8.682 • n=5 Participants	63 years STANDARD_DEVIATION 7.212 • n=7 Participants	63.5 years STANDARD_DEVIATION 8.023 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	71 Participants n=7 Participants	133 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian and/or Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African Amerian	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White/Caucasion, not of Hispanic origin	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Declined to State/Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaskan Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	67 Participants n=5 Participants	71 Participants n=7 Participants	138 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	BAI Arm n=67 Participants 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.	Usual Care n=70 Participants 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.
Change in Days of Unhealthy Alcohol Consumption Baseline Days of Unhealthy Alcohol Consumption	5.46 Unhealthy drinking days in last 30 Standard Deviation 9.24	7.16 Unhealthy drinking days in last 30 Standard Deviation 10.66
Change in Days of Unhealthy Alcohol Consumption 3-mo Days of Unhealthy Alcohol Consumption	2.72 Unhealthy drinking days in last 30 Standard Deviation 6.69	5.56 Unhealthy drinking days in last 30 Standard Deviation 10.68
Change in Days of Unhealthy Alcohol Consumption 6-mo Days of Unhealthy Alcohol Consumption	2.29 Unhealthy drinking days in last 30 Standard Deviation 6.37	4.78 Unhealthy drinking days in last 30 Standard Deviation 9.91

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	BAI Arm n=67 Participants 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.	Usual Care n=71 Participants 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.
Change in Drinking Days Baseline drinking days	9.39 Number of drinking days in last 30 Standard Deviation 10.44	12.41 Number of drinking days in last 30 Standard Deviation 11.47
Change in Drinking Days 3-mo drinking days	5.20 Number of drinking days in last 30 Standard Deviation 8.09	7.77 Number of drinking days in last 30 Standard Deviation 10.78
Change in Drinking Days 6-mo drinking days	4.61 Number of drinking days in last 30 Standard Deviation 7.66	8.26 Number of drinking days in last 30 Standard Deviation 10.67

SECONDARY outcome

Timeframe: Baseline, 3 months, and 6 months

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

Outcome measures

Outcome measures
Measure	BAI Arm n=67 Participants 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.	Usual Care n=71 Participants 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.
Change in Drinks Per Drinking Day Baseline Drinks per Drinking Day	3.57 Drinks per Drinking Day Standard Deviation 3.90	3.72 Drinks per Drinking Day Standard Deviation 3.69
Change in Drinks Per Drinking Day 3-mo Drinks per Drinking Day	2.29 Drinks per Drinking Day Standard Deviation 2.47	2.17 Drinks per Drinking Day Standard Deviation 2.17
Change in Drinks Per Drinking Day 6-mo Drinks per Drinking Day	1.98 Drinks per Drinking Day Standard Deviation 2.85	1.87 Drinks per Drinking Day Standard Deviation 1.90

SECONDARY outcome

Timeframe: Baseline, 3 months, and 6 months

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.

Outcome measures

Outcome measures
Measure	BAI Arm n=67 Participants 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.	Usual Care n=71 Participants 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.
Change in Symptoms of Psychological Distress (PHQ-9) Baseline PHQ-9	6.00 score on a scale Standard Deviation 5.70	6.68 score on a scale Standard Deviation 5.67
Change in Symptoms of Psychological Distress (PHQ-9) 3-mo PHQ-9	6.03 score on a scale Standard Deviation 5.65	6.91 score on a scale Standard Deviation 6.86
Change in Symptoms of Psychological Distress (PHQ-9) 6-mo PHQ-9	5.57 score on a scale Standard Deviation 5.07	7.44 score on a scale Standard Deviation 7.48

SECONDARY outcome

Timeframe: Baseline, 3 months, and 6 months

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.

Outcome measures

Outcome measures
Measure	BAI Arm n=67 Participants 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.	Usual Care n=71 Participants 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.
Change in SF-12 Physical Health Composite Baseline SF-12 Health	40.43 score on a scale Standard Deviation 12.20	40.49 score on a scale Standard Deviation 11.43
Change in SF-12 Physical Health Composite 3mo SF-12 Health	39.92 score on a scale Standard Deviation 12.25	41.59 score on a scale Standard Deviation 12.30
Change in SF-12 Physical Health Composite 6mo SF-12 Health	42.21 score on a scale Standard Deviation 10.43	40.75 score on a scale Standard Deviation 12.45

SECONDARY outcome

Timeframe: Baseline and 12 months

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

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

Outcome measures

Outcome measures
Measure	BAI Arm n=53 Participants 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.	Usual Care n=54 Participants 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.
Change in Additional Care	42412 US Dollars Standard Error 5381	51667 US Dollars Standard Error 8611

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months, and 6 months

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.

Outcome measures

Outcome measures
Measure	BAI Arm n=67 Participants 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. Usual Care: All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.	Usual Care n=71 Participants 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.
Change in SF-12 Mental Health Composite Baseline SF-12 Mental Health	49.10 score on a scale Standard Deviation 12.72	48.91 score on a scale Standard Deviation 11.87
Change in SF-12 Mental Health Composite 3mo SF-12 Mental Health	50.83 score on a scale Standard Deviation 9.94	49.25 score on a scale Standard Deviation 11.62
Change in SF-12 Mental Health Composite 6 mo SF-12 Mental Health	50.63 score on a scale Standard Deviation 10.59	48.51 score on a scale Standard Deviation 12.77

Adverse Events

Intervention: Web-Based BAI Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Control: Usual Care Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Intervention: Web-Based BAI Arm n=67 participants at risk 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.	Control: Usual Care Arm n=71 participants at risk 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.
General disorders Death	1.5% 1/67 • Number of events 1 • Adverse event data were collected for 4 years.	0.00% 0/71 • Adverse event data were collected for 4 years.
Renal and urinary disorders Death	0.00% 0/67 • Adverse event data were collected for 4 years.	1.4% 1/71 • Number of events 1 • Adverse event data were collected for 4 years.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Micheal Cucciare

Department of Veterans Affairs

Phone: 501-257-1068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place