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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
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatitis B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    April 10, 2015
    Last Updated
    October 5, 2020
    Sponsor
    Temple University
    Collaborators
    Patient-Centered Outcomes Research Institute
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    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

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

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