NCT02421666

A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2015-04-21
• Last updated: 2020-10-08
• Results posted: 2020-10-08