Medication Adherence in Youth With Sickle Cell Disease (SCD)
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 7/11/2015 |
| Start Date: | May 2014 |
| End Date: | May 2015 |
| Contact: | Jerlym Porter, PhD |
| Email: | info@stjude.org |
| Phone: | 866-278-5833 |
Use of WISE Device Technology to Measure Medication Adherence in Youth With Sickle Cell Disease (SCD): A Pilot Study
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.
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.
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.
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.
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.
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