Individual Patient Exposure and Response in Pediatric Lupus

Systemic Lupus Erythematosus Clinical Trial

— iPERSONAL  

Official title:

Individual Patient Exposure and Response in Pediatric Lupus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358302
• Other study ID #: Pro00104621
• Status: Completed
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: June 16, 2021

Study information

• Verified date: August 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 16, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence to hydroxychloroquine using the Medication Adherence Self-Reported Inventory (MASRI) score	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%.	Up to 6 months
Secondary	Adherence to hydroxychloroquine using serum drug levels	Serum drug levels will be measured by patient blood collection at study visits	Up to 6 months
Secondary	Adherence to hydroxychloroquine using electronic pill counts	Electronic pill counts will be obtained by the Pillsy device	Up to 6 months
Secondary	Adherence to hydroxychloroquine using manual pill counts	Manual pill counts will be conducted by the nurse at study visits	Up to 6 months
Secondary	Disease activity as measured by Systemic Lupus Activity Questionnaire (SLAQ) score	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.	Up to 6 months
Secondary	Disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score collected through a remote teleresearch exam	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.	Up to 2 months
Secondary	Disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score recorded in the CARRA Registry	SLEDAI-2K score recorded from the patient's closest CARRA Registry visit relative to visit 1	Up to 6 months