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Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease (SCD Mobile Dot)

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ClinicalTrials.gov Identifier: NCT02371720
Recruitment Status : Unknown
Verified July 2018 by Lakshmanan Krishnamurti, Emory University.
Recruitment status was:  Recruiting
First Posted : February 26, 2015
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Lakshmanan Krishnamurti, Emory University

Tracking Information
First Submitted Date  ICMJE February 19, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date July 23, 2018
Actual Study Start Date  ICMJE June 1, 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2015)
Medication Possession Ratio (MPR) [ Time Frame: 12 months ]
Proportion of days the patient is in possession of the medication in the study period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2015)
  • Change in Hemoglobin (Hb) levels [ Time Frame: Baseline, 24 months ]
    Change in hemoglobin levels from baseline to 24 months will be measured using the HemoCue® rapid test.
  • Change in mean cell volume (MCV) [ Time Frame: Baseline, 24 months ]
    Change from baseline in MCV will be calculated as the value at 24 months minus the value at baseline. MCV is the average size of the red blood cells expressed in femtoliters. MCV is calculated by dividing the hematocrit (as percent) by the RBC count in millions per microliter of blood, then multiplying by 10.
  • Change in fetal hemoglobin (HbF) levels [ Time Frame: Baseline, 24 months ]
    Change from baseline in HbF will be calculated as the value at 24 months minus the value at baseline. HbF is expressed as a percentage.
  • Impact of adherence on clinical outcomes and healthcare utilization [ Time Frame: Baseline, 24 months ]
    Health care utilization in the emergency department and hospitalization due to sickle cell related complications such as vaso-occlusive crisis (VOC) or acute chest syndrome (ACS). Retrospective chart review at baseline will be conducted to determine healthcare utilization.
  • Impact of adherence on patients' lives [ Time Frame: Baseline, 24 months ]
    Impact of adherence on patients' lives measured using patient reported outcomes (PROMIS), surveys of school attendance, work absenteeism, out-of-pocket costs incurred by patients and their caregivers
  • Change in adherence with using Mobile-DOT [ Time Frame: Baseline, 24 months ]
    Retrospective chart review at baseline will be conducted to determine medication possession rate (MPR) and then compared to the MPR at 24 months.
  • Acceptability of intervention and of Hydroxyurea [ Time Frame: Baseline, 24 months ]
    Acceptability will be measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness, Side Effects, Convenience, and Global Satisfaction, and it utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Scores range from 0-100, with 0 as extremely dissatisfied and 100 as extremely satisfied.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease
Official Title  ICMJE Patient Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy With Hydroxyurea in Patients With Sickle Cell Disease
Brief Summary The purpose of this research study is to learn about ways to help children and adults with sickle cell disease who are taking the medication, hydroxyurea.
Detailed Description Sickle cell disease (SCD) is an inherited chronic multi-organ system disorder that affects approximately 100,000 individuals in the United States, mostly belonging to minority, under-served populations. SCD is associated with substantial morbidity, premature mortality, individual suffering, health care costs and loss of productivity. Hydroxyurea (HU) the only disease modifying therapy for SCD is efficacious in reducing complications such as pain crisis and acute chest syndrome and improving survival. It is however, vastly underutilized and poorly adhered to because of barriers at the health care system, provider, treatment, socioeconomic, and patient levels. The investigator's overarching hypothesis is that barriers to acceptance and adherence to HU are multi-factorial and that a structured set of interventions can lead to improved adherence to medication and patient centered outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Behavioral: Mobile DOT
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Other Name: Comprehensive medication adherence management
Study Arms  ICMJE
  • Experimental: Adults - Mobile DOT
    Subjects with SCD that are older than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period. The subjects will receive the Mobile DOT intervention for 24 months.
    Intervention: Behavioral: Mobile DOT
  • Active Comparator: Adults - standard of care then Mobile DOT
    Subjects with SCD that are older than 21 years old will receive standard of care for the first 12 months. They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
    Intervention: Behavioral: Mobile DOT
  • Experimental: Children - Mobile DOT
    Subjects with SCD that are younger than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period. The subjects will receive the Mobile DOT intervention for 24 months.
    Intervention: Behavioral: Mobile DOT
  • Active Comparator: Children - standard of care then Mobile DOT
    Subjects with SCD that are younger than 21 years old will receive standard of care for the first 12 months. They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
    Intervention: Behavioral: Mobile DOT
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 19, 2015)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be >2 years of age up to 65 years of age, inclusive
  • Have a diagnosis of SCD, with either βS/βS, βS/βC, βS/βD , βS/β0 , βS/βO-Arab, or βS/β+ genotype
  • Prescribed Hydroxyurea for at least the 6 months prior to study entry
  • Have daily access to a smart phone, tablet, personal computer or other device capable of producing and transmitting videos over the internet
  • Be willing and able to record and transmit videos

Exclusion Criteria:

  • Patient or caregiver refuses Hydroxyurea.
  • Diagnosis of significant psychiatric disorder of the subject that could seriously impede the ability to participate in the study.
  • An assessment by the investigator that the subject will not comply with the study procedures outlined in the study protocol.
  • Patient is on liquid form of Hydroxyurea since MPR - calculations are difficult.
  • Patients receiving automatic home delivery of medications since medication possession ratio is reflective of the patient initiation the refill when they have exhausted the home supply of HU.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 65 Years   (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 NCT02371720
Other Study ID Numbers  ICMJE IRB00074105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lakshmanan Krishnamurti, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Study Chair: Lakshmanan Krishnamurti, MD Emory University/Children's Healthcare of Atlanta
PRS Account Emory University
Verification Date July 2018

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