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Use of Mobile Technology for Intensive Training in Medication Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Duke University
Sponsor:
Collaborator:
Sicklesoft Inc
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02133560
First received: May 6, 2014
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
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 Intervention
Sickle Cell Disease
Thalassemia
Behavioral: Video recording
Behavioral: Medication Administration Log
Behavioral: Education

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Use of Mobile Technology for Intensive Training in Medication Management

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02133560

Contacts
Contact: Nirmish Shah, MD 919-684-0628 nirmish.shah@dm.duke.edu
Contact: Jude Jonassaint, RN 919-668-6035 jude.jonassaint@dm.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jude Jonassaint, RN    919-668-6035    jude.jonassaint@dm.duke.edu   
Principal Investigator: Nirmish Shah, MD         
Sponsors and Collaborators
Duke University
Sicklesoft Inc
Investigators
Principal Investigator: Nirmish Shah, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02133560     History of Changes
Other Study ID Numbers: Pro00052665
Study First Received: May 6, 2014
Last Updated: July 28, 2016

Keywords provided by Duke University:
Sickle cell
Thalassemia
Adherence

Additional relevant MeSH terms:
Anemia, Sickle Cell
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on March 28, 2017