Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| behavioral PNMI | Experimental | eligible patients received patient navigator led plus mobile phone text messaging intervention(PNMI) or standard care. |
|
| control | No Intervention | eligible chronic HBV patients received standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNMI | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-month and 12-month follow up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients were excluded from the study for the following conditions:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Grace X Ma, PhD | Temple University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36749506 | Derived | Ma GX, Zhu L, Tan Y, Zhai S, Ma X, Ogunwobi OO, Yang WJ, Ting T, Kim S, Wang MQ. A Comparative Trial of Improving Care for Underserved Asian Americans Infected with Hepatitis B Virus. Dig Dis Sci. 2023 Jun;68(6):2333-2343. doi: 10.1007/s10620-023-07840-5. Epub 2023 Feb 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | eligible chronic HBV patients received usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study Baseline |
| |||||||||||||
| 6-month Follow-up |
| |||||||||||||
| 12-month Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | A total of 506 participants completed the 6-month follow-up assessment, among which 479 completed the 12-month follow-up assessment. | Posted | Count of Participants | Participants | 6-month and 12-month follow up |
|
through study completion, an average of 1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
In this study, we validated only those who reported their follow up visits and blood tests in collaboration with clinical partners; validating for all participants enrolled would be ideal. The results may not represent all Asian American groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace X. Ma | Center for Asian Health, Lewis Katz School of Medicine, Temple University | 2157078823 | grace.ma@temple.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2014 | Jul 22, 2020 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Usual Care | eligible chronic HBV patients received usual care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| States of Residence | Count of Participants | Participants |
|
| OG001 | Usual Care | eligible chronic HBV patients received usual care |
|
|
| 0 |
| 272 |
| 0 |
| 272 |
| 0 |
| 272 |
| EG001 | Usual Care | eligible chronic HBV patients received usual care | 0 | 260 | 0 | 260 | 0 | 260 |
Not provided
Not provided
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |