An interventional study of PNMI in Hepatitis B, sponsored by Temple University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Temple University · Not applicable, Interventional, and Supportive care
Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial.
Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. Inadequate chronic hepatitis B (CHB) monitoring and care are also likely to contribute to poorer outcomes and increased healthcare costs. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial. The primary outcome of the study is Asian CHB patient adherence (measured as "having seen a doctor for CHB monitoring") to hepatitis B (HBV) monitoring guidelines at 6-month and 12-month assessments post-intervention.
Patient partners and stakeholders were engaged in all study stages. The findings of this study provided unique and promising opportunities for broadly disseminating and implementing the evidence-based intervention in the real-world practice, thus further preventing chronic liver diseases and reducing health disparities among high-risk underserved populations.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 532 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients were excluded from the study for the following conditions:
eligible patients received patient navigator led plus mobile phone text messaging intervention(PNMI) or standard care.
Behavioral: PNMI
eligible chronic HBV patients received standard care
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.
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection
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.
Time frame: 6-month and 12-month follow up
| Milestone | Behavioral PNMI | Usual Care |
|---|---|---|
| Started | 272 | 260 |
| Completed | 272 | 260 |
| Not completed | 0 | 0 |
| Milestone | Behavioral PNMI | Usual Care |
|---|---|---|
| Started | 272 | 260 |
| Completed | 259 | 247 |
| Not completed | 13 | 13 |
| Withdrew: Lost to follow-up | 8 | 7 |
| Withdrew: Withdrawal by subject | 5 | 6 |
| Milestone | Behavioral PNMI | Usual Care |
|---|---|---|
| Started | 259 | 247 |
| Completed | 248 | 231 |
| Not completed | 11 | 16 |
| Withdrew: Lost to follow-up | 5 | 5 |
| Withdrew: Withdrawal by subject | 6 | 11 |
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.
| Participants | Behavioral PNMI | Usual Care |
|---|---|---|
| Doctor's Visit by 6-month follow-up | 200 | 113 |
| Doctor's Visit by 12-month follow-up | 225 | 140 |
| Blood Test (ALT) by 6-month follow-up | 137 | 62 |
| Blood Test (ALT) by 12-month follow-up | 164 | 87 |
Collected over through study completion, an average of 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral PNMI | 0/272 (0%) | 0/272 (0%) | 0/272 (0%) |
| Usual Care | 0/260 (0%) | 0/260 (0%) | 0/260 (0%) |
| Age, Continuous(years) | Behavioral PNMI | Usual Care | Total |
|---|---|---|---|
| Mean | 50 (20 to 88) | 49 (19 to 86) | 50 (19 to 88) |
| Sex: Female, Male(Participants) | Behavioral PNMI | Usual Care | Total |
|---|---|---|---|
| Female | 119 | 133 | 252 |
| Male | 153 | 127 | 280 |
| Race/Ethnicity, Customized(Participants) | Behavioral PNMI | Usual Care | Total |
|---|---|---|---|
| Chinese | 225 | 216 | 441 |
| Vietnamese | 17 | 23 | 40 |
| Korean | 30 | 21 | 51 |
| States of Residence(Participants) | Behavioral PNMI | Usual Care | Total |
|---|---|---|---|
| Pennsylvania/New Jersey | 164 | 160 | 324 |
| New York | 108 | 100 | 208 |
No study locations are listed for this record.
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