Individual Patient Exposure and Response in Pediatric Lupus (iPERSONAL)

Duke University

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Behavioral: Pillsy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04358302

Pro00104621

Details and patient eligibility

About

The purpose of this research study is to see if an electronic pill bottle cap can help children and teens with systemic lupus better remember to take their medicine. It will also gather information on the best dose of hydroxychloroquine (Plaquenil®) for children and teens. Participants in this study will continue to take their usual medication as prescribed by their doctors. Participants will receive an electronic pill bottle cap, a smartphone, and a Fitbit. Over 6 months, a nurse will visit each participant 4 times to ask questions about symptoms, draw blood, and take a urine sample. After the study, participants will be able to keep the electronic pill bottle cap and Fitbit, but will return the smartphone.

Full description

This is an exploratory Phase 2, single site, open-label, direct-to-family, adherence and exposure-response study of hydroxychloroquine (HCQ) in pediatric systemic lupus. The study will measure a participant's adherence to HCQ self-administration using an electronic pill bottle cap that records date/time of bottle opening and provides participants with a reminder when a dosage is due and/or missed. All participants will be provided with the electronic pill bottle cap to use with their regular HCQ prescription at the start of the study. For 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). Participants will continue to receive notifications via the electronic pill bottle cap through Visit 4. Throughout the study, participants will undergo a series of blood draws and urinalysis collections, and be asked to complete various questionnaires.

Enrollment: 26 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed and dated informed consent form and assent, when necessary
2. Age 5-17.5 years at consent
3. Enrolled in the CARRA Registry with a diagnosis of systemic lupus erythematosus as documented in the CARRA Registry
4. Receiving hydroxychloroquine as standard of care for ≥ 3 months
5. Participant and Caregiver primary language of English
6. Willing and able to comply with study procedures, at the discretion of the study principal investigator
7. Access to internet

Exclusion criteria

There are no pre-defined exclusion criterion for this trial.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Device use

Experimental group

Description:

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.

Treatment:

Behavioral: Pillsy