Use of Mobile Technology for Intensive Training in Medication Management

Duke University

Status: Completed

Conditions: Thalassemia; Sickle Cell Disease

Treatments: Behavioral: Medication Administration Log; Behavioral: Video recording; Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02133560

Pro00052665

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Medication Administration + Education

Other group

Description:

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.

Treatment:

Behavioral: Video recording

Behavioral: Education

Behavioral: Medication Administration Log