Individual Patient Exposure and Response in Pediatric Lupus

NCT04358302 | Completed

• 1 other identifier: Pro00104621
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Keywords

hydroxychloroquine; virtual trial

Outcome Measures

Primary Outcomes (1)

• Change in proportion of dispensed doses from the first two weeks (baseline) to last two weeks of study (device use)

  The Pillsy device will record the number of dispensed doses

  Days 1-14 compared to days 166-180 (+/- 30)

Secondary Outcomes (7)

• Adherence to hydroxychloroquine using the Medication Adherence Self-Reported Inventory (MASRI) score

  Up to 6 months

• Adherence to hydroxychloroquine using plasma drug levels

  Up to 6 months

• Adherence to hydroxychloroquine using electronic pill counts

  Up to 6 months

• Adherence to hydroxychloroquine using manual pill counts

  Up to 6 months

• Disease activity as measured by Systemic Lupus Activity Questionnaire (SLAQ) score

  Up to 6 months

Study Arms (1)

Device use

EXPERIMENTAL

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.

Behavioral: Pillsy

Interventions

Pillsy BEHAVIORAL

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

Device use

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27701, United States

Location

Related Publications (2)

• Balevic SJ, Randell R, Weiner D, Beard C, Schanberg LE, Hornik CP, Cohen-Wolkowiez M, Gonzalez D; with the CARRA Registry investigators. Pharmacokinetics of hydroxychloroquine in paediatric lupus: data from a novel, direct-to-family clinical trial. Lupus Sci Med. 2022 Nov;9(1):e000811. doi: 10.1136/lupus-2022-000811.

  PMID: 36328395 DERIVED

• Randell RL, Singler L, Cunningham A, Schanberg LE, Cohen-Wolkowiez M, Hornik CP, Balevic SJ; with the CARRA Registry investigators. Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial. Lupus Sci Med. 2021 May;8(1):e000494. doi: 10.1136/lupus-2021-000494.

  PMID: 33963084 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stephen J Balevic, MD, MHS

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 24, 2020
• Study Start: September 28, 2020
• Primary Completion: June 16, 2021
• Study Completion: June 16, 2021
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)