Individual Patient Exposure and Response in Pediatric Lupus (iPERSONAL)

August 19, 2021 updated by: Duke University
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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Days 1-14 compared to days 166-180 (+/- 30)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Up to 6 months
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
Up to 6 months
Adherence to hydroxychloroquine using electronic pill counts
Time Frame: Up to 6 months
Electronic pill counts will be obtained by the Pillsy device
Up to 6 months
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
Up to 6 months
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.
Up to 6 months
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.
Up to 2 months
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
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Stephen J Balevic, MD, MHS, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 28, 2020

Primary Completion (ACTUAL)

June 16, 2021

Study Completion (ACTUAL)

June 16, 2021

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (ACTUAL)

April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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