Use of Mobile Technology for Intensive Training in Medication Management
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|ClinicalTrials.gov Identifier: NCT02133560|
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : May 25, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Thalassemia||Behavioral: Video recording Behavioral: Medication Administration Log Behavioral: Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Use of Mobile Technology for Intensive Training in Medication Management|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||August 1, 2016|
|Actual Study Completion Date :||August 1, 2016|
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.
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.
- 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.
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|Ages Eligible for Study:||5 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Clinical diagnosis of sickle cell or thalassemia
- History of iron overload
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133560
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Nirmish Shah, MD||Duke University|
|Responsible Party:||Duke University|
|Other Study ID Numbers:||
|First Posted:||May 8, 2014 Key Record Dates|
|Last Update Posted:||May 25, 2017|
|Last Verified:||May 2017|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn