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A Nationwide Epidemiological, Educational Support Program for Improving Treatment Adherence in Patients With HBV

NCT01991262 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-07-24

No results posted yet for this study

Summary

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.

Conditions

  • HBV Treatment Adherence by Support Program

Sponsors & Collaborators

  • Carmel Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991262 on ClinicalTrials.gov