Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229580
Status:
COMPLETED
Last Update Posted:
2007-11-30
First Post:
2005-09-27
Brief Title:
Health Behavior Feedback Study for Veterans With Hepatitis C
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Health Behavior Feedback Study for Veterans With Hepatitis C
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to explore whether a brief 3 session intervention would impact health behavior of veterans with hepatitis C The main focus of the intervention was on reduction of heavy drinking with patients who have liver disease Other study goals were to increase the likelihood that patients would seek out substance use treatment andor hepatitis C health care services The study also tested the use of a liver function test called CDTGGT in detecting heavy drinking The main hypothesis was that a 3 session intervention with personalized feedback about health behavior would result in a reduction in alcohol use and increased use of substance use treatment and hepatology health care
Detailed Description:
OBJECTIVES To establish the feasibility of a brief intervention for hepatitis C HCV patients who drink alcohol The primary aim was reduction in alcohol use which is known to be hazardous for patients with chronic HCV infection Secondary aims were 1 to increase patient engagement in substance use disorder SUD treatment 2 to explore patient engagement in HCV specialty care treatment acceptability and impact on other health-related behaviors and 3 to examine pre-post intervention differences in relation to report of alcohol use and to explore whether the CDTGGT merits tracking to detect heavy drinking in this population given hepatic pathology
DESIGN Randomized controlled trial with six-week and 12-week post-baseline assessment follow-up The control group was offered the brief intervention at completion of the 12-week post-baseline follow-up
PARTICIPANTS We had anticipated recruiting 60 veterans who were HCV referred for HCV specialty care education or treatment evaluation and who met criteria for hazardous alcohol use Due to problems with recruitment only 12 veterans participated in the study see below
RECRUITMENT We started regular study recruitment September 27 2004 but study recruitment was much slower than anticipated Despite multiple modifications to change our recruitment eligibility criteria we enrolled only twelve subjects N12 Due to this ongoing recruitment problem we decided to end study enrollment on 93005 with follow-up completion in December 2005 Despite an extension of the Alcoholic Beverage Medical Research Foundation grant there was no progress in identifying an alternative recruitment or developing an appropriate follow-up study
MEASURES Baseline assessment included demographic information the Alcohol Use Disorders Identification Test AUDIT Form - 90 recent alcohol and drug use a DSM-IV SUD criteria checklist a Health Behavior Questionnaire and the K-10 brief measure of psychological distress For brief intervention feedback the Short Inventory of Problems negative consequences of alcohol use the SOCRATES stage of readiness to change blood draw for liver function tests and two brief measures of neuropsychological functioning were administered VA treatment utilization data SUD and specialty HCV treatment attendance was obtained Follow-up sessions also included measures of treatment acceptability and concept retention
INTERVENTION Participants in the brief intervention condition received personalized feedback and encouragement to explore ambivalence about change and treatment in three sessions Feedback and interventions were tailored to individuals health-related behavior with emphasis on alcohol use
COMPLETION DATA Ten participants were randomized to receive the feedback session and two were randomized to receive the treatment as usual or control group Of the twelve participants enrolled eight individuals 7 randomized 1 control completed all study sessions one completed 2 of the 3 required sessions 1 control and three who received the intervention completed only the initial baseline session
DEMOGRAPHICS We had eleven men and one female enroll in the study The mean age of our participants was 55 years old Five subjects identified themselves as African American or Black while seven identified themselves as Caucasian or White Half N6 of the group were divorced and 42 N5 of the group were unemployed at the time they enrolled in the study Over half 58 of the subjects had completed some college in their lifetime
SUD INFORMATION AND FEEDBACK All subjects receiving the feedback sessions received a Personal Feedback Report at their first intervention session This report incorporated data from the SOCRATES SUD criteria checklist Form 90 - revised the SIP and the Health Behavior Questionnaire which was collected at an earlier baseline session For those receiving the feedback sessions N10 all had a primary diagnosis of alcohol dependence while eight also endorsed use of additional substances cocaine opiates cannabis andor amphetamines
Compared to individuals of the same gender in the population the mean percentile rank of drinking norms was 975 sd 326 Based on data from the Form- 90 regarding typical weekly drinking patterns and levels of intoxication the subjects in the feedback session had a reported mean Blood Alcohol Concentration BAC level of 13 sd 13 in a typical week with a mean typical heavy day of drinking reaching a BAC of 23 sd 30 Subjects received feedback on the common effects of different levels of intoxication and how their self-reported drinking compared
Besides receiving feedback on their drinking and the associated negative consequences subjects also received feedback on their reported drug use Cocaine and cannabis were the most frequently used drugs within the 30 days prior to the baseline with subjects reporting mean use of 34 sd 67 sd 63 respectively days out of 30 Subjects also received feedback on their smoking habits Of the ten non-randomized subjects nine reported some tobacco use at baseline and no one reported decreased or discontinued use of tobacco after receiving the intervention
TREATMENT ACCEPTABILITY After the follow-up appointments we asked subjects N7 to rate their acceptance of the study intervention sessions on 14 different items ranging from their feelings of the discussions sessions to ratings on the therapist they met with throughout the study Items were scored on a scale of 1-7 At the final follow-up 71 N5 reported the sessions as being valuable and easy to complete Ninety percent N6 of the subjects who completed follow-up also reported the therapist as being helpful and caring towards them in the sessions
DESIGN Randomized controlled trial with six-week and 12-week post-baseline assessment follow-up The control group was offered the brief intervention at completion of the 12-week post-baseline follow-up
PARTICIPANTS We had anticipated recruiting 60 veterans who were HCV referred for HCV specialty care education or treatment evaluation and who met criteria for hazardous alcohol use Due to problems with recruitment only 12 veterans participated in the study see below
RECRUITMENT We started regular study recruitment September 27 2004 but study recruitment was much slower than anticipated Despite multiple modifications to change our recruitment eligibility criteria we enrolled only twelve subjects N12 Due to this ongoing recruitment problem we decided to end study enrollment on 93005 with follow-up completion in December 2005 Despite an extension of the Alcoholic Beverage Medical Research Foundation grant there was no progress in identifying an alternative recruitment or developing an appropriate follow-up study
MEASURES Baseline assessment included demographic information the Alcohol Use Disorders Identification Test AUDIT Form - 90 recent alcohol and drug use a DSM-IV SUD criteria checklist a Health Behavior Questionnaire and the K-10 brief measure of psychological distress For brief intervention feedback the Short Inventory of Problems negative consequences of alcohol use the SOCRATES stage of readiness to change blood draw for liver function tests and two brief measures of neuropsychological functioning were administered VA treatment utilization data SUD and specialty HCV treatment attendance was obtained Follow-up sessions also included measures of treatment acceptability and concept retention
INTERVENTION Participants in the brief intervention condition received personalized feedback and encouragement to explore ambivalence about change and treatment in three sessions Feedback and interventions were tailored to individuals health-related behavior with emphasis on alcohol use
COMPLETION DATA Ten participants were randomized to receive the feedback session and two were randomized to receive the treatment as usual or control group Of the twelve participants enrolled eight individuals 7 randomized 1 control completed all study sessions one completed 2 of the 3 required sessions 1 control and three who received the intervention completed only the initial baseline session
DEMOGRAPHICS We had eleven men and one female enroll in the study The mean age of our participants was 55 years old Five subjects identified themselves as African American or Black while seven identified themselves as Caucasian or White Half N6 of the group were divorced and 42 N5 of the group were unemployed at the time they enrolled in the study Over half 58 of the subjects had completed some college in their lifetime
SUD INFORMATION AND FEEDBACK All subjects receiving the feedback sessions received a Personal Feedback Report at their first intervention session This report incorporated data from the SOCRATES SUD criteria checklist Form 90 - revised the SIP and the Health Behavior Questionnaire which was collected at an earlier baseline session For those receiving the feedback sessions N10 all had a primary diagnosis of alcohol dependence while eight also endorsed use of additional substances cocaine opiates cannabis andor amphetamines
Compared to individuals of the same gender in the population the mean percentile rank of drinking norms was 975 sd 326 Based on data from the Form- 90 regarding typical weekly drinking patterns and levels of intoxication the subjects in the feedback session had a reported mean Blood Alcohol Concentration BAC level of 13 sd 13 in a typical week with a mean typical heavy day of drinking reaching a BAC of 23 sd 30 Subjects received feedback on the common effects of different levels of intoxication and how their self-reported drinking compared
Besides receiving feedback on their drinking and the associated negative consequences subjects also received feedback on their reported drug use Cocaine and cannabis were the most frequently used drugs within the 30 days prior to the baseline with subjects reporting mean use of 34 sd 67 sd 63 respectively days out of 30 Subjects also received feedback on their smoking habits Of the ten non-randomized subjects nine reported some tobacco use at baseline and no one reported decreased or discontinued use of tobacco after receiving the intervention
TREATMENT ACCEPTABILITY After the follow-up appointments we asked subjects N7 to rate their acceptance of the study intervention sessions on 14 different items ranging from their feelings of the discussions sessions to ratings on the therapist they met with throughout the study Items were scored on a scale of 1-7 At the final follow-up 71 N5 reported the sessions as being valuable and easy to complete Ninety percent N6 of the subjects who completed follow-up also reported the therapist as being helpful and caring towards them in the sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None