A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
Primary Purpose
Hepatitis B
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PNMI
Sponsored by
About this trial
This is an interventional supportive care trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- self-identified Chinese, Korean and Vietnamese ethnicity
- age 18 and above
- accessible by telephone with text message feature
- presence in the same geographic study area for a period of one year
- not enrolled in any chronic HBV adherence management intervention
- medically diagnosed chronic HBV infection with positive for hepatitis B surface antigen (HBsAg) for more than six months, and
- Never or non compliant with HBV monitoring guidelines.
Exclusion Criteria:
Patients were excluded from the study for the following conditions:
- diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer
- concurrent hepatitis C infection, and
- concurrent HIV infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
behavioral PNMI
control
Arm Description
eligible patients received patient navigator led plus mobile phone text messaging intervention(PNMI) or standard care.
eligible chronic HBV patients received standard care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02421666
First Posted
April 10, 2015
Last Updated
October 5, 2020
Sponsor
Temple University
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02421666
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
532 (Actual)
8. Arms, Groups, and Interventions
Arm Title
behavioral PNMI
Arm Type
Experimental
Arm Description
eligible patients received patient navigator led plus mobile phone text messaging intervention(PNMI) or standard care.
Arm Title
control
Arm Type
No Intervention
Arm Description
eligible chronic HBV patients received standard care
Intervention Type
Behavioral
Intervention Name(s)
PNMI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
self-identified Chinese, Korean and Vietnamese ethnicity
age 18 and above
accessible by telephone with text message feature
presence in the same geographic study area for a period of one year
not enrolled in any chronic HBV adherence management intervention
medically diagnosed chronic HBV infection with positive for hepatitis B surface antigen (HBsAg) for more than six months, and
Never or non compliant with HBV monitoring guidelines.
Exclusion Criteria:
Patients were excluded from the study for the following conditions:
diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer
concurrent hepatitis C infection, and
concurrent HIV infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace X Ma, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
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