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Individual Patient Exposure and Response in Pediatric Lupus (iPERSONAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358302
Recruitment Status : Completed
First Posted : April 24, 2020
Last Update Posted : August 23, 2021
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Behavioral: Pillsy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Individual Patient Exposure and Response in Pediatric Lupus
Actual Study Start Date : September 28, 2020
Actual Primary Completion Date : June 16, 2021
Actual Study Completion Date : June 16, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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%.

  2. 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

  3. Adherence to hydroxychloroquine using electronic pill counts [ Time Frame: Up to 6 months ]
    Electronic pill counts will be obtained by the Pillsy device

  4. 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

  5. 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.

  6. 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.

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358302


Locations
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United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: Stephen J Balevic, MD, MHS Duke Clinical Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04358302    
Other Study ID Numbers: Pro00104621
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
hydroxychloroquine
virtual trial
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases