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Use of Mobile Technology for Intensive Training in Medication Management

Primary Purpose

Sickle Cell Disease, Thalassemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video recording
Medication Administration Log
Education
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sickle Cell Disease focused on measuring Sickle cell, Thalassemia, Adherence

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Medication Administration + Education

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2014
Last Updated
May 24, 2017
Sponsor
Duke University
Collaborators
Sicklesoft Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02133560
Brief Title
Use of Mobile Technology for Intensive Training in Medication Management
Official Title
Use of Mobile Technology for Intensive Training in Medication Management
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 1, 2016 (Actual)
Study Completion Date
August 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Sicklesoft Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Thalassemia
Keywords
Sickle cell, Thalassemia, Adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication Administration + Education
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video recording
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medication Administration Log
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase adherence to medication regimen
Description
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.
Time Frame
Baseline, 3 month, 6 month, 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of sickle cell or thalassemia History of iron overload Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirmish Shah, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Use of Mobile Technology for Intensive Training in Medication Management

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