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Medication Adherence in Youth With Sickle Cell Disease (SCD)

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ClinicalTrials.gov Identifier: NCT02143076
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date May 16, 2014
First Posted Date May 20, 2014
Last Update Posted Date May 27, 2015
Study Start Date May 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2014)
  • Percent Rate of Consent to Study Participation [ Time Frame: Baseline ]
    Of the total number of eligible participants, the percent of participants who agree to participate.
  • Percent Rate of Device Use [ Time Frame: Two months after baseline ]
    The percent of the total participants who keep medicine in the device during the entire trial period.
  • Percent Rate of Device Failure [ Time Frame: Two months after baseline ]
    Percent of devices that failed defined as a device does not register opening as verified by study staff at the time device is returned to the study team.
  • Acceptability of Using the Wise Device [ Time Frame: Two months after baseline ]
    Responses by participants and/or caregivers to the Acceptability Questionnaire based on the Likert scale from strongly disagree to strongly agree.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 16, 2014)
Medication Adherence as Measured by Wise Device Compared to Other Measures of Medication Adherence [ Time Frame: Two months after baseline ]
Adherence will be determined and compared between: a) adherence indicated by Wise device, b) adherence indicated by caregiver and youth-report, c) adherence indicated by lab values, d) adherence indicated by pill count/bottle volume, and e) adherence indication by medication possession ratio (MPR). Each participant's Wise adherence will be calculated as: [(number of device openings ÷ medication prescribed) x 100] where larger percentages suggest better adherence (range: 0-100%). Descriptive statistics for Wise device adherence and other adherence measures, including mean and standard deviation, median and interquartile range, will be estimated. Spearman's rank correlation coefficients and intraclass correlations between different adherence measures will be calculated to measure the associations between HU adherence measures for the entire sample as well as for each age group.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Medication Adherence in Youth With Sickle Cell Disease (SCD)
Official Title Use of WISE Device Technology to Measure Medication Adherence in Youth With Sickle Cell Disease (SCD): A Pilot Study
Brief Summary

Youth diagnosed with sickle cell disease (SCD) may have difficulty taking medication as prescribed (adherence). Hydroxyurea (HU) is one medication that youth may take to help manage SCD. Electronic adherence monitoring is widely considered the gold standard in objective adherence measurement. These monitors provide continuous, real-time records of medication adherence and reveal problematic behavior patterns, including underdosing, overdosing, delayed dosing, "drug holidays" (i.e. where individuals do not take medications for a specified interval of time), and "white coat" adherence (i.e., a pattern of drug adherence as a function of time where individuals display good adherence immediately before and after clinic attendance with worsening adherence in the period between).

Overall, electronic adherence measures are considered valid, reliable, and accurate, with clear advantages over pharmacy refill records, physician estimates and self-report measures. Currently, only one electronic measure capable of monitoring medications in both pill and liquid form is being manufactured: WisePill and WiseBag. While data are limited regarding its validity and reliability, preliminary data support the use of Wise technology to measure adherence to medication. The current study will determine the Wise device's ability to feasibly measure adherence to liquid and solid form HU medication in a pediatric SCD population.

Detailed Description

This research study will evaluate HU adherence using an electronic storage device (Wise device) compared to caregiver report, youth report, lab values, and pill-count adherence measures. The investigators will ask participants to store their medication in the Wise device and answer questions about their use of the device during normal clinical care visits.

PRIMARY OBJECTIVE

  • To examine feasibility of the WISE device by estimating a) rate of consent to the study, b) rate of WISE device use, c) rate of WISE device failure, and d) the perceived acceptability of using the WISE device, as reported by caregivers and youth.

SECONDARY OBJECTIVE

  • To estimate the association between HU adherence as measured by the Wise device, to a) caregiver-report, b) youth-report, c) lab values, d) pill-count, and e) Medication Possession Ratio (MPR) adherence measures.

Evaluation of study outcomes will be stratified by age group: (1) infants/toddlers, ages 0-7 years; (2) school age, ages 8-12 years; and (3) teen, ages 13-17 years.

At study enrollment, participants will be asked to complete one questionnaire and will receive instructions on how to use the Wise device. They will be asked to use the Wise device over the following two months. A study team member will contact each participant by phone within seven days of study enrollment to monitor participant use of the Wise device and to answer any questions. Participants will be asked to return the Wise device in two months at their normal clinic care visit. At this visit, participants will be asked to complete two more questionnaires and, as part of standard clinical care, a pill count/bottle weight will be completed by the pharmacy.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will have a diagnosis of sickle cell disease,be receiving treatment with hydroxyurea, and meet eligibility criteria.
Condition Sickle Cell Disease
Intervention
  • Behavioral: Demographic Questionnaire
    At study enrollment, participants will complete a questionnaire to collect demographic information about the participant's family background, education and living situation.
  • Behavioral: Medical Adherence Measure Questionnaire

    At the two-month follow-up visit, participants will be asked to complete a questionnaire describing all medications prescribed for them, when they take their medications, how much medication they take each time, how many times during the week they missed taking or were late taking each medication, reasons why they missed or were late, and how they manage their medications.

    In the case that a participant's clinic schedule is delayed greater than two months from the time of consent (e.g., missed appointment, change in clinic appointment frequency), procedures scheduled for the anticipated 2-month visit will take place at the participant's next clinic appointment.

  • Behavioral: Acceptability Questionnaire

    At the two-month follow-up visit, participants will be asked to complete a questionnaire about their perceptions of using the Wise electronic medication container.

    In the case that a participant's clinic schedule is delayed greater than two months from the time of consent (e.g., missed appointment, change in clinic appointment frequency), procedures scheduled for the anticipated 2-month visit will take place at the participant's next clinic appointment.

Study Groups/Cohorts Sickle Cell Disease
Participants will complete three questionnaires during the course of the study: Demographic Questionnaire, Medical Adherence Measure Questionnaire, and Acceptability Questionnaire. All questionnaires will be completed in a private clinic room.
Interventions:
  • Behavioral: Demographic Questionnaire
  • Behavioral: Medical Adherence Measure Questionnaire
  • Behavioral: Acceptability Questionnaire
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 Completed
Actual Enrollment
 (submitted: May 26, 2015)
36
Original Estimated Enrollment
 (submitted: May 16, 2014)
60
Actual Study Completion Date May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Confirmed diagnosis of SCD (any genotype).
  • Less than 18 years of age at time of study entry.
  • Currently followed in the St. Jude Children's Research Hospital (SJCRH) SCD clinic.
  • Stable HU dose prescribed (in pill or liquid formulation) for ≥ 6 months without documented hematological toxicity (excluding dose adjustments for weight gain).
  • Lives with their primary caregiver.
  • Anticipated to return to clinic at proposed 4-week or 8-week intervals.

Exclusion Criteria:

  • Primary caregiver and/or youth unable to understand English and/or youth not cognitively intact (known IQ < 70) such that the study questionnaire cannot be understood and completed.
  • Any condition or chronic illness that in the opinion of the PI or Co-I makes participation on the study ill-advised.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02143076
Other Study ID Numbers WISEP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor St. Jude Children's Research Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Lisa Ingerski, PhD St. Jude Children's Research Hospital
Principal Investigator: Jerlym Porter, PhD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date May 2015