Individual Patient Exposure and Response in Pediatric Lupus (iPERSONAL)
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|ClinicalTrials.gov Identifier: NCT04358302|
Recruitment Status : Completed
First Posted : April 24, 2020
Last Update Posted : August 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Behavioral: Pillsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, direct-to-family, adherence and exposure-response study of hydroxychloroquine (HCQ) self-administration in pediatric lupus participants with the use of an electronic pill bottle cap that provides automatic dosing reminders|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Individual Patient Exposure and Response in Pediatric Lupus|
|Actual Study Start Date :||September 28, 2020|
|Actual Primary Completion Date :||June 16, 2021|
|Actual Study Completion Date :||June 16, 2021|
Experimental: Device use
All participants will be provided with the electronic pill bottle cap called "Pillsy" to use with their regular HCQ prescription bottles at the start of the study.
The electronic pill bottle cap, Pillsy, and its accompanying software application provides reminders to take a scheduled dosage of medication via bottle cap alerts and smartphone push notifications, text messages, and/or automated phone calls. The Pillsy application records dosing dispense date and time when the user opens the bottle. During the first 2 weeks of the trial, the electronic notifications will be disabled to determine a baseline measure of adherence. Within 1 day after Visit 2, the electronic notifications will be turned on for all participants, resulting in a series of alerts (via electronic pill bottle cap alerts and smartphone push notifications, text message, and/or automated phone calls).
The electronic pill bottle cap, Pillsy, is a commercially available device marketed to consumers. The electronic pill bottle cap does not capture or store PHI. Quick tips on how to use Pillsy can be found at https://www.pillsy.com/instructions
- Change in proportion of dispensed doses from the first two weeks (baseline) to last two weeks of study (device use) [ Time Frame: Days 1-14 compared to days 166-180 (+/- 30) ]The Pillsy device will record the number of dispensed doses
- Adherence to hydroxychloroquine using the Medication Adherence Self-Reported Inventory (MASRI) score [ Time Frame: Up to 6 months ]The MASRI is a concise, self-administered survey completed by the patient at study visits. The MASRI is a patient-reported numeric estimate of medication adherence rate (0-100%) with non-adherence defined as MASRI <80% and adherence defined as >/=80%.
- Adherence to hydroxychloroquine using serum drug levels [ Time Frame: Up to 6 months ]Serum drug levels will be measured by patient blood collection at study visits
- Adherence to hydroxychloroquine using electronic pill counts [ Time Frame: Up to 6 months ]Electronic pill counts will be obtained by the Pillsy device
- Adherence to hydroxychloroquine using manual pill counts [ Time Frame: Up to 6 months ]Manual pill counts will be conducted by the nurse at study visits
- Disease activity as measured by Systemic Lupus Activity Questionnaire (SLAQ) score [ Time Frame: Up to 6 months ]The SLAQ is a concise, self-administered survey completed by the patient at study visits. The SLAQ measures patient-reported disease activity and scores range from 0-44, with 0 representing no disease activity and 44 representing maximum disease activity.
- Disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score collected through a remote teleresearch exam [ Time Frame: Up to 2 months ]A physician will conduct a remote SLEDAI-2K assessment of the patient at study visit 1. The SLEDAI-2K measures physician-reported disease activity and scores range from 0-105, with 0 representing no disease activity and 105 representing maximum disease activity. A score of >/=6 represents clinically important disease activity and a reduction of at least 4 represents clinically meaningful improvement in disease activity.
- Disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score recorded in the CARRA Registry [ Time Frame: Up to 6 months ]SLEDAI-2K score recorded from the patient's closest CARRA Registry visit relative to visit 1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358302
|United States, North Carolina|
|Duke Clinical Research Institute|
|Durham, North Carolina, United States, 27701|
|Principal Investigator:||Stephen J Balevic, MD, MHS||Duke Clinical Research Institute|