Trial Outcomes & Findings for A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV (NCT NCT02421666)
NCT ID: NCT02421666
Last Updated: 2020-10-08
Results Overview
The primary outcome is adherence to recommended clinical care for the monitoring of chronic HBV infection, specifically: 1) whether they visited doctors for their CHB, and 2) whether they received a blood test every 6 months such as alanine transaminase (ALT). All primary outcome measures were assessed at both the 6-month and 12-month follow-up surveys.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
532 participants
Primary outcome timeframe
6-month and 12-month follow up
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
Behavioral PNMI
Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
|
Usual Care
eligible chronic HBV patients received usual care
|
|---|---|---|
|
Overall Study Baseline
STARTED
|
272
|
260
|
|
Overall Study Baseline
COMPLETED
|
272
|
260
|
|
Overall Study Baseline
NOT COMPLETED
|
0
|
0
|
|
6-month Follow-up
STARTED
|
272
|
260
|
|
6-month Follow-up
COMPLETED
|
259
|
247
|
|
6-month Follow-up
NOT COMPLETED
|
13
|
13
|
|
12-month Follow-up
STARTED
|
259
|
247
|
|
12-month Follow-up
COMPLETED
|
248
|
231
|
|
12-month Follow-up
NOT COMPLETED
|
11
|
16
|
Reasons for withdrawal
| Measure |
Behavioral PNMI
Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
|
Usual Care
eligible chronic HBV patients received usual care
|
|---|---|---|
|
6-month Follow-up
Lost to Follow-up
|
8
|
7
|
|
6-month Follow-up
Withdrawal by Subject
|
5
|
6
|
|
12-month Follow-up
Lost to Follow-up
|
5
|
5
|
|
12-month Follow-up
Withdrawal by Subject
|
6
|
11
|
Baseline Characteristics
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
Baseline characteristics by cohort
| Measure |
Behavioral PNMI
n=272 Participants
Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
|
Usual Care
n=260 Participants
eligible chronic HBV patients received usual care
|
Total
n=532 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
49 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
225 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
441 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Vietnamese
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
States of Residence
Pennsylvania/New Jersey
|
164 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
States of Residence
New York
|
108 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-month and 12-month follow upPopulation: A total of 506 participants completed the 6-month follow-up assessment, among which 479 completed the 12-month follow-up assessment.
The primary outcome is adherence to recommended clinical care for the monitoring of chronic HBV infection, specifically: 1) whether they visited doctors for their CHB, and 2) whether they received a blood test every 6 months such as alanine transaminase (ALT). All primary outcome measures were assessed at both the 6-month and 12-month follow-up surveys.
Outcome measures
| Measure |
Behavioral PNMI
n=259 Participants
Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
|
Usual Care
n=247 Participants
eligible chronic HBV patients received usual care
|
|---|---|---|
|
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection
Doctor's Visit by 6-month follow-up
|
200 Participants
|
113 Participants
|
|
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection
Doctor's Visit by 12-month follow-up
|
225 Participants
|
140 Participants
|
|
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection
Blood Test (ALT) by 6-month follow-up
|
137 Participants
|
62 Participants
|
|
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection
Blood Test (ALT) by 12-month follow-up
|
164 Participants
|
87 Participants
|
Adverse Events
Behavioral PNMI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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: 2157078823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place