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Use of Mobile Technology for Intensive Training in Medication Management

NCT02133560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-05-25

No results posted yet for this study

Summary

Purpose: Assess whether intensive training with education and daily remote monitoring with provider involvement has a lasting positive impact on adherence to medication management. The study will seek to enroll 25 subjects with sickle cell disease or thalassemia, and less than 100% compliance for taking iron chelators in the previous three month prior to participation in the study. Subjects will be asked to monitor their daily iron chelator administration by taking a video recording of preparing it and ingesting at least one sip. Subjects will also use a medication log to record daily administration of medication, and meet with study staff monthly for educational activities. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management. Mean percent adherence in the pre-study periods and each of the study periods will be analyzed and compared.

Conditions

Interventions

BEHAVIORAL

Video recording

Subjects will be asked to monitor their daily iron chelator administration by taking a video recording of preparing it and ingesting at least one sip. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management.

BEHAVIORAL

Medication Administration Log

Subjects will be asked to monitor their daily iron chelator administration by completing the medication administration log on a daily basis. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management.

BEHAVIORAL

Education

During this first six months period a study staff member will see subjects at each scheduled clinic visit they attend for regular blood transfusion. Subjects will receive educational material and short quizzes related to sickle cell disease, thalassemia, iron overload, or iron chelation.

Sponsors & Collaborators

Principal Investigators

  • Nirmish Shah, MD · Duke University

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-08-01
Completion
2016-08-01

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT02133560 on ClinicalTrials.gov