Use of Mobile Technology for Intensive Training in Medication Management

May 24, 2017 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of sickle cell or thalassemia
  • History of iron overload

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Medication Administration + Education
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 during months 1-3 and completing the medication administration log during months 1-6. During months 1-6 subjects will meet with study staff and receive educational materials on a monthly basis. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase adherence to medication regimen
Time Frame: Baseline, 3 month, 6 month, 12 month
Assess whether intensive training with education and daily remote monitoring with provider involvement has a lasting positive impact on adherence to medication management. Mean percent adherence in the pre-study periods and each of the study periods will be analyzed and compared. The ANOVA will be performed to compare adherence to medication administration during periods of intensive interactions, period prior to study enrollment, and period post training during regular care follow-up.
Baseline, 3 month, 6 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Sicklesoft Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (ESTIMATE)

May 8, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00052665

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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