Individual Patient Exposure and Response in Pediatric Lupus

NCT ID: NCT04358302

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2021-06-16

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.

Detailed 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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pillsy

Intervention Type: 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

Interventions

Pillsy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Balevic, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Locations

Duke Clinical Research Institute

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36328395 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33963084 (View on PubMed)

Other Identifiers

Pro00104621

Identifier Type: -

Identifier Source: org_study_id