Trial Outcomes & Findings for Hepatitis C-Video vs. Brochure Education Delivery (NCT NCT04204447)
NCT ID: NCT04204447
Last Updated: 2024-09-19
Results Overview
The main outcome measure was a change in the mean score on a 25-item HCV knowledge assessment without subscales. The instrument values ranged from 0 to 25 with one point per correct answer to questions directly arising from the information contained in the video. One point was assigned to each correct answer, and an increase in the score indicated more correct responses.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
176 participants
Primary outcome timeframe
Pre-intervention, Immediate post-intervention, and 1 mo. follow up
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Brochure Intervention
Subjects will be asked to read an educational brochure about Hepatitis C
Hepatitis C Educational Brochure: Subjects will receive information about Hepatitis C through a brochure
|
Video Intervention
Subjects will be asked to watch an educational video about Hepatitis C
Hepatitis C Educational Video: Subjects will receive information about Hepatitis C through a video
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
86
|
|
Overall Study
COMPLETED
|
83
|
81
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
row population totals when summed do equal overall population
Baseline characteristics by cohort
| Measure |
Brochure Intervention
n=90 Participants
Subjects will be asked to read an educational brochure about Hepatitis C
Hepatitis C Educational Brochure: Subjects will receive information about Hepatitis C through a brochure
|
Video Intervention
n=86 Participants
Subjects will be asked to watch an educational video about Hepatitis C
Hepatitis C Educational Video: Subjects will receive information about Hepatitis C through a video
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 11 • n=5 Participants
|
41 years
STANDARD_DEVIATION 12 • n=7 Participants
|
42 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Other race · American Indian or Alaska Native
|
1 Participants
n=5 Participants • row population totals when summed do equal overall population
|
0 Participants
n=7 Participants • row population totals when summed do equal overall population
|
1 Participants
n=5 Participants • row population totals when summed do equal overall population
|
|
Race (NIH/OMB)
Other race · Asian
|
0 Participants
n=5 Participants • row population totals when summed do equal overall population
|
0 Participants
n=7 Participants • row population totals when summed do equal overall population
|
0 Participants
n=5 Participants • row population totals when summed do equal overall population
|
|
Race (NIH/OMB)
Other race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • row population totals when summed do equal overall population
|
0 Participants
n=7 Participants • row population totals when summed do equal overall population
|
0 Participants
n=5 Participants • row population totals when summed do equal overall population
|
|
Race (NIH/OMB)
Other race · Black or African American
|
12 Participants
n=5 Participants • row population totals when summed do equal overall population
|
1 Participants
n=7 Participants • row population totals when summed do equal overall population
|
13 Participants
n=5 Participants • row population totals when summed do equal overall population
|
|
Race (NIH/OMB)
Other race · White
|
76 Participants
n=5 Participants • row population totals when summed do equal overall population
|
74 Participants
n=7 Participants • row population totals when summed do equal overall population
|
150 Participants
n=5 Participants • row population totals when summed do equal overall population
|
|
Race (NIH/OMB)
Other race · More than one race
|
0 Participants
n=5 Participants • row population totals when summed do equal overall population
|
0 Participants
n=7 Participants • row population totals when summed do equal overall population
|
0 Participants
n=5 Participants • row population totals when summed do equal overall population
|
|
Race (NIH/OMB)
Other race · Unknown or Not Reported
|
1 Participants
n=5 Participants • row population totals when summed do equal overall population
|
11 Participants
n=7 Participants • row population totals when summed do equal overall population
|
12 Participants
n=5 Participants • row population totals when summed do equal overall population
|
PRIMARY outcome
Timeframe: Pre-intervention, Immediate post-intervention, and 1 mo. follow upThe main outcome measure was a change in the mean score on a 25-item HCV knowledge assessment without subscales. The instrument values ranged from 0 to 25 with one point per correct answer to questions directly arising from the information contained in the video. One point was assigned to each correct answer, and an increase in the score indicated more correct responses.
Outcome measures
| Measure |
Brochure Intervention
n=90 Participants
Subjects will be asked to read an educational brochure about Hepatitis C
Hepatitis C Educational Brochure: Subjects will receive information about Hepatitis C through a brochure
|
Video Intervention
n=86 Participants
Subjects will be asked to watch an educational video about Hepatitis C
Hepatitis C Educational Video: Subjects will receive information about Hepatitis C through a video
|
|---|---|---|
|
Improvement in Scores on HCV Knowledge Questionnaire
One month post-intervention
|
20.2 Improvement in scores
Standard Deviation .3
|
21.7 Improvement in scores
Standard Deviation 0.2
|
|
Improvement in Scores on HCV Knowledge Questionnaire
Pre-intervention
|
18.45 Improvement in scores
Standard Deviation .3
|
19 Improvement in scores
Standard Deviation 0.25
|
|
Improvement in Scores on HCV Knowledge Questionnaire
Immiediate post-intervention
|
20.3 Improvement in scores
Standard Deviation .35
|
21.75 Improvement in scores
Standard Deviation 0.3
|
Adverse Events
Video Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brochure Intervention
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