Trial record 140 of 439 for:    hepatitis b | Open Studies

A Nationwide Epidemiological, Non-Interventional Study Evaluating an Educational Support Program for Improving Treatment Adherence in Patients With Hepatitis B Viral Infection (Help-B)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Eli Zuckerman, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01991262
First received: November 17, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

Protocol Title: A Nationwide Epidemiological, Non-Interventional Study Evaluating an Educational Support Program for Improving Treatment Adherence in Patients with Hepatitis B Viral Infection

Objective(s): The primary objectives of the study are to assess:

  • HBV treatment adherence rate in patients enrolled in the Support Program
  • Adherence rates at 6m, 12m.

The secondary objectives are to assess:

  • Adverse events rate and profile.
  • Actual treatment duration and dose taken vs. prescribed.
  • The impact of SMS reminders.

Study Design: Eligible patients will be randomized into one of four groups: Group 1 shall receive both a weekly phone call from a supporter and a daily SMS reminder. Group 2 will receive a weekly phone call only. Group 3 will receive a daily SMS reminder only and group 4 (Control) shall receive no support.

Study Population: Adult newly diagnosed with Hep B patients, eligible to begin treatment with first line therapy.

Data Collection Methods:

  1. Supporter's documentations of patient's self assessment.
  2. Drugs dispense data from pharmacies
  3. Pills count.

Condition
HBV Treatment Adherence by Support Program

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Nationwide Epidemiological, Non-Interventional Study Evaluating an Educational Support Program for Improving Treatment Adherence in Patients With Hepatitis B Viral Infection

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Hepatitis B treatment adherence rate in patients with support system [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 252
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1 phone call and SMS reminder.
Group 2 phone call only.
Group 3 SMS reminder only .
group 4 (Control) no support

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult newly diagnosed with chronic hepatitis B patients, eligible to begin treatment with first line therapy.

Criteria

Inclusion Criteria:

  • Adult male and female patient (> 18 years).
  • Prescribed treatment of Entecavir for HBV
  • Must have access to a smart-phone.
  • Written informed consent.

Exclusion Criteria:

  • • Patients with hepatitis C, hepatitis D or HIV co-infection.

    • Co-infected patients who require additional medication.
    • Patients with prior liver transplantation
    • Patients with impaired renal function requiring dialysis
    • Immune-suppressed patients receiving HBV antiviral prophylaxis
    • Pregnant patients.
    • Inability or unwillingness to provide informed consent or abide by the requirements of the study.
    • Parallel participation in another clinical trial.
    • Patients who cannot take medication independently.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Eli Zuckerman, Director of Liver Unit, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01991262     History of Changes
Other Study ID Numbers: AI463-972
Study First Received: November 17, 2013
Last Updated: November 17, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Virus Diseases
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 22, 2014