Despite the well-documented benefits of hydroxyurea (HU) therapy in decreasing morbidity and mortality in youth with Sickle cell disease (SCD), pediatric HU adherence rates range as low as 49% and lead to discontinuation of HU regimens in 8-20%. In addition, treatment non-adherence may lead to unnecessary increases in medication dosage resulting from erroneous assumption that a patient is non-responsive to treatment (versus non-adherent to the regimen as prescribed). Given the detrimental effects of non-adherence, assessment of and intervention for HU non-adherence is essential to improving health outcomes in the pediatric SCD population. 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," and "white coat" adherence. Overall, electronic adherence measures are considered valid, reliable, and accurate, with clear advantages over pharmacy refill records, physician estimates and self-report measures. The primary purpose of this pilot study is to determine the use of the AdhereTech as a feasible and valid measure of HU adherence in pediatric SCD. Primary Objective Estimate the association between HU adherence as measured by the AdhereTech device to a) caregiver-report, b) youth-report, c) lab values, d) pill- count, and e) Medication Possession Ratio (MPR) adherence measures Secondary Objectives Estimate the rate of consent to the study, the rate of AdhereTech device use, the rate of AdhereTech device failure, and the perceived acceptability of using the AdhereTech device, as reported by caregivers and youth
The AdhereTech smart bottle is an electronic medicine dispenser with a tracking and reminder system connected wirelessly. The device provides real time adherence aids to the patient and this information is relayed to the provider. The device can sense the amount of pills remaining inside the bottle. This information is measured periodically and concurrently sent to a secure database using cellular data technology. Thus, AdhereTech bottles can be used to determine whether medication was removed from the bottle, the amount of medication removed, and the timing of removal. Participants ages 12.0-17.99 who are receiving HU prescribed in pill form will use the AdhereTech smart bottle for a two-month period. Participants and their caregivers will complete self-report measures of adherence at the baseline, 1 month and 2 month clinic visits, a Demographic questionnaire at the baseline clinic visit and an Acceptability questionnaire at the 1 month and 2 month clinic visits using Audio Computer-Assisted Self-Interviews (ACASI) on a password protected laptop. Lab values and clinical information will be obtained through medical records review and adherence information from pill counts and pharmacy records.
Study Type
OBSERVATIONAL
Enrollment
36
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Estimate the association between AdhereTech device HU adherence to caregiver-report of adherence
For each subject, we will calculate the proportion of days of opening the AdhereTech device across the two month study period (days with missing information will not be counted). Caregiver-report of their child's HU adherence will be assessed by the Medical Adherence Measure (MAM), a measure of 7-day self-reported adherence. Each subject's caregiver-reported adherence will be calculated as: \[(medication reported taken \[(medication reported taken ÷ medication prescribed) x 100\]. We will estimate the Spearman's rank-based correlation, with 95% confidence interval, of the AdhereTech device adherence with the caregiver-report of their child's adherence.
Time frame: Continuous over two months, baseline to off study
Estimate the association between AdhereTech device HU adherence to youth-reported adherence
For each subject, we will calculate the proportion of days of opening the AdhereTech device across the two month study period (days with missing information will not be counted). Youth-report of their HU adherence will be assessed by the Medical Adherence Measure (MAM), a measure of 7-day self-reported adherence. Each subject's self-reported adherence will be calculated as: \[(medication reported taken \[(medication reported taken ÷ medication prescribed) x 100\]. We will estimate the Spearman's rank-based correlation, with 95% confidence interval, of the AdhereTech device adherence with the youth-reported adherence.
Time frame: Continuous over two months, baseline to off study
Estimate the association between AdhereTech device HU adherence to fetal hemoglobin (HbF) lab values
For each subject, we will calculate the proportion of days of opening the AdhereTech device across the two month study period (days with missing information will not be counted). We will extract fetal hemoglobin (HbF; g/dl) lab value from each subject's medical record. We will estimate the Spearman's rank-based correlation, with 95% confidence interval, of the AdhereTech device adherence with the fetal hemoglobin (HbF) lab value.
Time frame: Continuous over two months, baseline to off study
Estimate the association between AdhereTech device HU adherence to mean corpuscular volume (MCV) lab values
For each subject, we will calculate the proportion of days of opening the AdhereTech device across the two month study period (days with missing information will not be counted). We will extract mean corpuscular volume (MCV; L) lab value from each subject's medical record. We will estimate the Spearman's rank-based correlation, with 95% confidence interval, of the AdhereTech device adherence with the mean corpuscular volume (MCV) lab value .
Time frame: Continuous over two months, baseline to off study
Estimate the association between AdhereTech device HU adherence to the Medication Possession Ratio (MPR)
For each subject, we will calculate the proportion of days of opening the AdhereTech device across the two month study period (days with missing information will not be counted). Medication Possession Ratio (MPR) will be calculated as: \[(number of days medication in family's possession ÷ number of days for which medication prescribed) x 100\]. We will estimate the Spearman's rank-based correlation, with 95% confidence interval, of the AdhereTech device adherence with the Medication Possession Ratio (MPR).
Time frame: Continuous over two months, baseline to off study
Estimate the association between AdhereTech device HU adherence to pill count
For each subject, we will calculate the proportion of days of opening the AdhereTech device across the two month study period (days with missing information will not be counted). We will calculate each subject's pill count adherence as: \[(number of pills removed ÷ medication prescribed) x 100\]. We will estimate the Spearman's rank-based correlation, with 95% confidence interval, of the AdhereTech device adherence with pill count adherence.
Time frame: Continuous over two months, baseline to off study
Estimate rate of consent to the study
We will descriptively examine rate of refusal and study participation: (Number participants consented ÷ Total families approached) x 100%
Time frame: Once, at baseline
Estimate rate of AdhereTech device use
We will descriptively examine rate of AdhereTech device use: (Number participants keeping medication in device during entire trial ÷ Total participants) x 100%
Time frame: Continuous over two months, baseline to off study
Estimate rate of AdhereTech device failure
We will descriptively examine AdhereTech device failure (i.e., a device does not register openings as verified by study staff at the time device is returned to study team): (Number devices failing ÷ Total devices) x 100%
Time frame: Continuous over two months, baseline to off study
Estimate the perceived acceptability of using the AdhereTech device, as reported by caregivers and youth
We will descriptively examine reported acceptability of using the AdhereTech device: Point estimation and interval estimations for the counts and frequencies of favorable responses of acceptability will be calculated.
Time frame: Continuous over two months, baseline to off study
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