Trial Outcomes & Findings for Hepatitis C Self-Management (NCT NCT00328042)
NCT ID: NCT00328042
Last Updated: 2015-04-24
Results Overview
The QWB-SA is a preference-based measure of health-related quality of life. Scores range from 0 to 1.0, with 0 representing death, and 1.0 representing asymptomatic, optimal functioning. Thus, higher scores indicate higher quality of life.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
Base Line, 12 months
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
Self-Management Workshop
Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
|
Information Only
Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
65
|
|
Overall Study
COMPLETED
|
69
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hepatitis C Self-Management
Baseline characteristics by cohort
| Measure |
Arm 1
n=69 Participants
Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
|
Arm 2
n=65 Participants
Self-management self-study: This is an individual self-paced at home study program.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
54.6 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (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
|
69 participants
n=5 Participants
|
65 participants
n=7 Participants
|
134 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Base Line, 12 monthsThe QWB-SA is a preference-based measure of health-related quality of life. Scores range from 0 to 1.0, with 0 representing death, and 1.0 representing asymptomatic, optimal functioning. Thus, higher scores indicate higher quality of life.
Outcome measures
| Measure |
Arm 1
n=69 Participants
Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
|
Arm 2
n=63 Participants
Self-management self-study: This is an individual self-paced at home study program.
|
|---|---|---|
|
Quality of Well-being Scale - Self-Administered (QWB-SA)
Baseline QWB-SA score
|
.534 units on a scale
Standard Deviation .153
|
.501 units on a scale
Standard Deviation .163
|
|
Quality of Well-being Scale - Self-Administered (QWB-SA)
12-month QWB-SA score
|
.600 units on a scale
Standard Deviation .170
|
.504 units on a scale
Standard Deviation .152
|
SECONDARY outcome
Timeframe: Base Line, 6 weeksThe measure consists of 15 questions covering Hepatitis C-specific information related to disease self-management. Each correct response is scored as one point, with total scores range from 0 to 15. Higher scores indicate higher levels of Hepatitis C-specific knowledge. There are no subscales.
Outcome measures
| Measure |
Arm 1
n=69 Participants
Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
|
Arm 2
n=63 Participants
Self-management self-study: This is an individual self-paced at home study program.
|
|---|---|---|
|
Hepatitis C Knowledge Questionnaire
Baseline HCV Knowledge
|
8.74 units on a scale
Standard Deviation 3.12
|
8.60 units on a scale
Standard Deviation 2.71
|
|
Hepatitis C Knowledge Questionnaire
6-weeks HCV Knowledge
|
12.29 units on a scale
Standard Deviation 2.16
|
9.92 units on a scale
Standard Deviation 2.75
|
Adverse Events
Self-Management Workshop
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information-Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place