Use of Mobile Technology for Intensive Training in Medication Management

Sickle Cell Disease Clinical Trial

Official title:

Use of Mobile Technology for Intensive Training in Medication Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133560
• Other study ID #: Pro00052665
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: May 24, 2017
• Start date: May 2014
• Est. completion date: August 1, 2016

Study information

• Verified date: May 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 1, 2016
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of sickle cell or thalassemia

• History of iron overload

Exclusion Criteria:

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease
• Thalassemia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Sicklesoft Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase adherence to medication regimen	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