Exploring Adherence Monitoring in Sickle Cell Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 3/24/2019 |
| Start Date: | March 12, 2019 |
| End Date: | January 2024 |
| Contact: | Jerlym Porter, PhD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
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
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.
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.
Inclusion Criteria:
- Confirmed diagnosis of SCD (any genotype)
- Ages 12.0 - 17.99 at time of study enrollment
- Stable HU dose composed of only one capsule strength prescribed in pill formulation
for ≥ 6 months without documented hematological toxicity (excluding dose adjustments
for weight gain)
- Lives with their legal guardian
- Anticipated to return to clinic at proposed 4-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.
- Participant unable to complete the questionnaires due to refusal or current acute
illness (e.g., pain crisis).
- Inability or unwillingness of research participant or legal guardian/representative to
give written informed consent.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Jerlym Porter, PhD
Phone: 866-278-5833
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