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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
Sponsor:
Collaborator:
Sicklesoft Inc
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE May 6, 2014
First Posted Date  ICMJE May 8, 2014
Last Update Posted Date May 25, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date August 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Mobile Technology for Intensive Training in Medication Management
Official Title  ICMJE Use of Mobile Technology for Intensive Training in Medication Management
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Sickle Cell Disease
  • Thalassemia
Intervention  ICMJE
  • 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.

Study Arms  ICMJE 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.
Interventions:
  • Behavioral: Video recording
  • Behavioral: Medication Administration Log
  • Behavioral: Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2017)
46
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
25
Actual Study Completion Date  ICMJE August 1, 2016
Actual Primary Completion Date August 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02133560
Other Study ID Numbers  ICMJE Pro00052665
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Sicklesoft Inc
Investigators  ICMJE
Principal Investigator: Nirmish Shah, MD Duke University
PRS Account Duke University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP