Clinical trial NCT02421666: A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
Official title: A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-04-21
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection
timeFrame: 6-month and 12-month follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Temple University
name: Grace X Ma, PhD
role: PRINCIPAL_INVESTIGATOR
References: