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Systemic Lupus ErythematosusiPERSONALNCT04358302

Individual Patient Exposure and Response in Pediatric Lupus

A study testing Pillsy in people with Systemic Lupus Erythematosus, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Pillsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
28 Sep 2020to 16 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • There are no pre-defined exclusion criterion for this trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Clinical Research Institute

    Durham, North Carolina, 27701

Other trials in United States

About this study

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.

Read the 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.

Being tested
Pillsy
Keywords
hydroxychloroquine, virtual trial
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PillsyBehavioural

    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

Study groups in NCT04358302
Study groupRoleWhat they receive
Device useExperimentalAll 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.
Receives: Behavioral: Pillsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (7)

  1. 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%.

    Measured: Up to 6 months

  2. Adherence to hydroxychloroquine using plasma drug levels

    Plasma drug levels will be measured by patient blood collection at study visits

    Measured: Up to 6 months

  3. Adherence to hydroxychloroquine using electronic pill counts

    Electronic pill counts will be obtained by the Pillsy device

    Measured: Up to 6 months

  4. Adherence to hydroxychloroquine using manual pill counts

    Manual pill counts will be conducted by the nurse at study visits

    Measured: Up to 6 months

  5. 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.

    Measured: Up to 6 months

  6. 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.

    Measured: Up to 2 months

  7. 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

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start28 Sep 2020
  3. Primary completion16 Jun 2021
  4. Study completion16 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04358302
Sponsor's protocol ID
Pro00104621
Acronym
iPERSONAL
Status last verified
Jul 2024
First submitted
16 Apr 2020
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36328395

  • 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.

    PubMed 33963084

Questions about this trial

What is this clinical trial studying?

A study testing Pillsy in people with Systemic Lupus Erythematosus, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04358302, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.

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