Trial Outcomes & Findings for Chronic HBV Management for Asian American (NCT NCT04082338)
NCT ID: NCT04082338
Last Updated: 2023-06-22
Results Overview
percentage of subjects, who visited doctor's office for HBV at 12-month and 18-month Follow-Up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
382 participants
Primary outcome timeframe
12 months, 18 months
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
VPN Toolkit+TM
The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.
VPN: The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application). The system includes education modules on HBV management, CHB patient success stories and virtual patient navigation clinical support for overcoming barriers.
In addition to the VPN, each participant will receive 5 text messages; one message once a week for 5 weeks on HBV management for every 6 months in the 18-month study period.
TM: Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
|
Text Messages
Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period
TM: Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
|
|---|---|---|
|
Overall Study Baseline
STARTED
|
191
|
191
|
|
Overall Study Baseline
COMPLETED
|
191
|
191
|
|
Overall Study Baseline
NOT COMPLETED
|
0
|
0
|
|
12-month Follow-up
STARTED
|
191
|
191
|
|
12-month Follow-up
COMPLETED
|
186
|
186
|
|
12-month Follow-up
NOT COMPLETED
|
5
|
5
|
|
18-month Follow-up
STARTED
|
186
|
186
|
|
18-month Follow-up
COMPLETED
|
181
|
184
|
|
18-month Follow-up
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic HBV Management for Asian American
Baseline characteristics by cohort
| Measure |
VPN Toolkit+TM
n=191 Participants
The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.
VPN: The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application). The system includes education modules on HBV management, CHB patient success stories and virtual patient navigation clinical support for overcoming barriers.
In addition to the VPN, each participant will receive 5 text messages; one message once a week for 5 weeks on HBV management for every 6 months in the 18-month study period.
TM: Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
|
Text Messages
n=191 Participants
Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period
TM: Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.29 Years
STANDARD_DEVIATION 0.91 • n=99 Participants
|
53.18 Years
STANDARD_DEVIATION 1.04 • n=107 Participants
|
53.23 Years
STANDARD_DEVIATION 1.38 • n=206 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
198 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
184 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
148 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
298 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Vietnamese
|
43 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Born in the US
Yes
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Born in the US
No
|
190 Participants
n=99 Participants
|
187 Participants
n=107 Participants
|
377 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 months, 18 monthsPopulation: There are 3 cases (1 intervention, 2 control cases) missing information on doctor's visit at the 12-month follow-up assessment point.
percentage of subjects, who visited doctor's office for HBV at 12-month and 18-month Follow-Up
Outcome measures
| Measure |
VPN Toolkit+TM
n=185 Participants
The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.
VPN: The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application). The system includes education modules on HBV management, CHB patient success stories and virtual patient navigation clinical support for overcoming barriers.
In addition to the VPN, each participant will receive 5 text messages; one message once a week for 5 weeks on HBV management for every 6 months in the 18-month study period.
TM: Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
|
Text Messages
n=184 Participants
Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period
TM: Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
|
|---|---|---|
|
Adherence to Recommended HBV Monitoring: Doctor's Visits
Doctor's Visit by 12-month follow-up
|
159 Participants
|
100 Participants
|
|
Adherence to Recommended HBV Monitoring: Doctor's Visits
Doctor's Visit by 18-month follow-up
|
170 Participants
|
147 Participants
|
Adverse Events
VPN Toolkit+TM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Messages
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
Dr. Grace X. Ma
Center for Asian Health, Lewis Katz School of Medicine, Temple University
Phone: 215-707-6493
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place