Hepatitis B
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPNMI
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.
Sponsors
Patient-Centered Outcomes Research Institute
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. self-identified Chinese, Korean and Vietnamese ethnicity 2. age 18 and above 3. accessible by telephone with text message feature 4. presence in the same geographic study area for a period of one year 5. not enrolled in any chronic HBV adherence management intervention 6. medically diagnosed chronic HBV infection with positive for hepatitis B surface antigen (HBsAg) for more than six months, and 7. Never or non compliant with HBV monitoring guidelines.
Exclusion criteria
Patients were excluded from the study for the following conditions: 1. diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer 2. concurrent hepatitis C infection, and 3. concurrent HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection | 6-month and 12-month follow up | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 272 |
| Usual Care eligible chronic HBV patients received usual care | 260 |
| Total | 532 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Follow-up | Lost to Follow-up | 5 | 5 |
| 12-month Follow-up | Withdrawal by Subject | 6 | 11 |
| 6-month Follow-up | Lost to Follow-up | 8 | 7 |
| 6-month Follow-up | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | Behavioral PNMI | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 50 years | 49 years | 50 years |
| Race/Ethnicity, Customized Chinese | 225 Participants | 216 Participants | 441 Participants |
| Race/Ethnicity, Customized Korean | 30 Participants | 21 Participants | 51 Participants |
| Race/Ethnicity, Customized Vietnamese | 17 Participants | 23 Participants | 40 Participants |
| Sex: Female, Male Female | 119 Participants | 133 Participants | 252 Participants |
| Sex: Female, Male Male | 153 Participants | 127 Participants | 280 Participants |
| States of Residence New York | 108 Participants | 100 Participants | 208 Participants |
| States of Residence Pennsylvania/New Jersey | 164 Participants | 160 Participants | 324 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 272 | 0 / 260 |
| other Total, other adverse events | 0 / 272 | 0 / 260 |
| serious Total, serious adverse events | 0 / 272 | 0 / 260 |
Outcome results
Primary
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
Population: A total of 506 participants completed the 6-month follow-up assessment, among which 479 completed the 12-month follow-up assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral PNMI | 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 |
| Behavioral PNMI | 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 |
| Behavioral PNMI | 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 |
| Behavioral PNMI | 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 |
| Usual Care | 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 | 87 Participants |
| 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 | 113 Participants |
| Usual Care | 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 | 62 Participants |
| 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 12-month follow-up | 140 Participants |