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临床试验/NCT04082338
NCT04082338已完成不适用

Long-Term Adherence To Monitoring/Treatment In Underserved Asian Americans With Chronic HBV

Temple University3 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
382
试验地点
3
主要终点
Adherence to Recommended HBV Monitoring: Doctor's Visits

研究概览

简要总结

About 75% of liver cancers are attributed to chronic hepatitis B (CHB). An estimated 2.2 million individuals in the U.S. have CHB. Although Asian Americans make up 6% of total U.S. population, they account for over 58% of Americans with CHB. Prevalence rates of CHB range from 8% to 13% in Asian Americans vs 1% in Non-Hispanic whites (NHW). Asian Americans are 8-13 times more likely to develop liver cancer with 60% higher death rate than NHW. Regular monitoring of CHB is vital in preventing HCC. Research indicates that regular monitoring (e.g., every six months doctor visit; blood tests) combined with antiviral treatment when appropriate, is critical to reduce the risk of liver disease (including HCC). Unfortunately, treatment effectiveness diminishes if CHB patients do not adhere to long-term monitoring and treatment guidelines. Adherence among Asian Americans with CHB is low. Poor healthcare access and significant cultural barriers prevent long-term adherence to monitoring and optimal treatment, placing Asian Americans at disproportionately high risk for HCC and increased healthcare costs.

Building on previous studies, the investigators will use a virtual patient navigation (VPN) toolkit system (a web/mobile application) to help CHB patients improving their liver disease management.

详细描述

Liver cancer is the second-leading cause of cancer deaths worldwide, which increased at the highest rate of all cancers in the U.S between 2003 and 2012. Asian Americans have the highest incidence and mortality rates of hepatocellular carcinoma (HCC) of all U.S. racial/ethnic groups. About 75% of liver cancers are attributed to chronic hepatitis B (CHB). An estimated 2.2 million individuals in the U.S. have CHB. Although Asian Americans make up 6% of total U.S. population, they account for over 58% of Americans with CHB. Prevalence rates of CHB range from 8% to 13% in Asian Americans vs 1% in Non-Hispanic whites (NHW). Asian Americans are 8-13 times more likely to develop liver cancer with 60% higher death rate than NHW. Regular monitoring of CHB is vital in preventing HCC. Research indicates that regular monitoring (e.g., every six months doctor visit; blood tests) combined with antiviral treatment when appropriate, is critical to reduce the risk of liver disease (including HCC). Unfortunately, treatment effectiveness diminishes if CHB patients do not adhere to long-term monitoring and treatment guidelines. Adherence among Asian Americans with CHB is as low. Poor healthcare access and significant cultural barriers prevent long-term adherence to monitoring and optimal treatment, placing Asian Americans at a disproportionately high risk for HCC and increased healthcare costs.

Building on previous studies, the investigators will use a virtual patient navigation (VPN) toolkit system (a web/mobile application) to help CHB patients improving their liver disease management. This study addresses DHHS and NIH National top priorities, Institute of Medicine's national goal of eliminating HBV and urgent need to evaluate evidence-based interventions that can be integrated into primary care setting and other relevant settings.

The specific aims of the study are:

Aim 1 (Primary) Evaluate comparative effectiveness of Text Message (TM) vs VPN+TM in improving long-term adherence to monitoring (regular doctor visit; blood tests) at 12- and 18- month follow ups. Aim 2 (Secondary) Compare the effectiveness of TM vs VPN+TM in improving and sustaining medication adherence (measured through self-report and electronic monitoring) among Asian Americans with CHB who meet antiviral treatment guidelines. Aim 3 (Exploratory) Examine mediators of intervention effectiveness, including information (knowledge), motivation, and self-efficacy, as well as dose-response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and above
  • Self-identified Chinese, Korean or Vietnamese ethnicity
  • Chronic HBV infection with positive HBV surface antigen (HBsAg)
  • Non-compliant to HBV monitoring and treatment guidelines

排除标准

  • 未提供

研究组 & 干预措施

VPN Toolkit+TM

Experimental

The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.

干预措施: TM (Behavioral)

Text Messages

Active Comparator

Receive TM respectively once a week for 5 weeks for every 6 months in the 18-month study period

干预措施: TM (Behavioral)

VPN Toolkit+TM

Experimental

The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application) format.

干预措施: VPN (Behavioral)

结局指标

主要结局

Adherence to Recommended HBV Monitoring: Doctor's Visits

时间窗: 12 months, 18 months

percentage of subjects, who visited doctor's office for HBV at 12-month and 18-month Follow-Up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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