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Use of Mobile Technology for Intensive Training in Medication Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02133560
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
Sicklesoft Inc
Information provided by (Responsible Party):
Duke University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Thalassemia Behavioral: Video recording Behavioral: Medication Administration Log Behavioral: Education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Sicklesoft Inc
Investigators
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Principal Investigator: Nirmish Shah, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02133560    
Other Study ID Numbers: Pro00052665
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Keywords provided by Duke University:
Sickle cell
Thalassemia
Adherence
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn