Clinical Trials Directory

Trials / Completed

CompletedNCT02133560

Use of Mobile Technology for Intensive Training in Medication Management

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
5 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
BEHAVIORALVideo recordingSubjects 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.
BEHAVIORALMedication Administration LogSubjects 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.
BEHAVIORALEducationDuring 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.

Timeline

Start date
2014-05-01
Primary completion
2016-08-01
Completion
2016-08-01
First posted
2014-05-08
Last updated
2017-05-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02133560. Inclusion in this directory is not an endorsement.