Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct‐to‐Family Pilot Trial

Objective The objective of this study was to evaluate the preliminary effectiveness of an electronic pill bottle with automated reminders on hydroxychloroquine (HCQ) adherence in children with pediatric systemic lupus erythematosus (pSLE). Methods This was a self‐controlled, open label, direct‐to‐fa...

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Main Authors: Rachel L. Randell, Laura E. Schanberg, Claire Beard, Thomas Phillips, Christoph P. Hornik, Michael Cohen‐Wolkowiez, Stephen J. Balevic, with the CARRA Registry investigators
Format: Article
Language:English
Published: Wiley 2025-01-01
Series:ACR Open Rheumatology
Online Access:https://doi.org/10.1002/acr2.11780
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author Rachel L. Randell
Laura E. Schanberg
Claire Beard
Thomas Phillips
Christoph P. Hornik
Michael Cohen‐Wolkowiez
Stephen J. Balevic
with the CARRA Registry investigators
author_facet Rachel L. Randell
Laura E. Schanberg
Claire Beard
Thomas Phillips
Christoph P. Hornik
Michael Cohen‐Wolkowiez
Stephen J. Balevic
with the CARRA Registry investigators
author_sort Rachel L. Randell
collection DOAJ
description Objective The objective of this study was to evaluate the preliminary effectiveness of an electronic pill bottle with automated reminders on hydroxychloroquine (HCQ) adherence in children with pediatric systemic lupus erythematosus (pSLE). Methods This was a self‐controlled, open label, direct‐to‐family pilot trial. Children with pSLE treated with HCQ were recruited from the Childhood Arthritis and Rheumatology Research Alliance Registry. All participants received a pill bottle with a sensor in the cap to record openings and provide automated reminders, which were activated after a two‐week run‐in. The primary outcome was a change in adherence measured using the pill bottle over six months. Secondary outcomes included plasma HCQ concentrations and Medication Adherence Self‐Report Inventory (MASRI) scores, collected during four home visits. An exploratory post hoc analysis examined adherence patterns over time. Results Overall adherence was high and did not change over six months (mean ± SD proportion of recorded out of expected pill bottle openings, 0.86 ± 0.20 and 0.89 ± 0.16, P = 0.590). A post hoc analysis grouped participants by adherence pattern. The group with variable adherence, compared with the group with persistent high adherence, had lower dose‐adjusted HCQ concentrations at baseline (0.387 vs 0.627 ng/mL/mg, P = 0.04) and trended toward lower MASRI scores (77.1 vs 93.4, P = 0.09). After six months, there were no differences in HCQ concentrations or MASRI by group. Conclusion Automated reminders did not improve adherence to HCQ for children with pSLE, although the ability to detect effect was limited by a high baseline adherence and small sample size. Post hoc analyses identified different adherence patterns and a subgroup of patients with low HCQ concentrations who could be targeted for future adherence interventions.
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spelling doaj-art-911906bd3e32482ea18a6d6fa034695d2025-02-04T06:21:23ZengWileyACR Open Rheumatology2578-57452025-01-0171n/an/a10.1002/acr2.11780Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct‐to‐Family Pilot TrialRachel L. Randell0Laura E. Schanberg1Claire Beard2Thomas Phillips3Christoph P. Hornik4Michael Cohen‐Wolkowiez5Stephen J. Balevic6with the CARRA Registry investigatorsDuke University and Duke Clinical Research Institute Durham North CarolinaDuke University and Duke Clinical Research Institute Durham North CarolinaDuke Clinical Research Institute Durham North CarolinaDuke Clinical Research Institute Durham North CarolinaDuke University and Duke Clinical Research Institute Durham North CarolinaDuke University and Duke Clinical Research Institute Durham North CarolinaDuke University and Duke Clinical Research Institute Durham North CarolinaObjective The objective of this study was to evaluate the preliminary effectiveness of an electronic pill bottle with automated reminders on hydroxychloroquine (HCQ) adherence in children with pediatric systemic lupus erythematosus (pSLE). Methods This was a self‐controlled, open label, direct‐to‐family pilot trial. Children with pSLE treated with HCQ were recruited from the Childhood Arthritis and Rheumatology Research Alliance Registry. All participants received a pill bottle with a sensor in the cap to record openings and provide automated reminders, which were activated after a two‐week run‐in. The primary outcome was a change in adherence measured using the pill bottle over six months. Secondary outcomes included plasma HCQ concentrations and Medication Adherence Self‐Report Inventory (MASRI) scores, collected during four home visits. An exploratory post hoc analysis examined adherence patterns over time. Results Overall adherence was high and did not change over six months (mean ± SD proportion of recorded out of expected pill bottle openings, 0.86 ± 0.20 and 0.89 ± 0.16, P = 0.590). A post hoc analysis grouped participants by adherence pattern. The group with variable adherence, compared with the group with persistent high adherence, had lower dose‐adjusted HCQ concentrations at baseline (0.387 vs 0.627 ng/mL/mg, P = 0.04) and trended toward lower MASRI scores (77.1 vs 93.4, P = 0.09). After six months, there were no differences in HCQ concentrations or MASRI by group. Conclusion Automated reminders did not improve adherence to HCQ for children with pSLE, although the ability to detect effect was limited by a high baseline adherence and small sample size. Post hoc analyses identified different adherence patterns and a subgroup of patients with low HCQ concentrations who could be targeted for future adherence interventions.https://doi.org/10.1002/acr2.11780
spellingShingle Rachel L. Randell
Laura E. Schanberg
Claire Beard
Thomas Phillips
Christoph P. Hornik
Michael Cohen‐Wolkowiez
Stephen J. Balevic
with the CARRA Registry investigators
Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct‐to‐Family Pilot Trial
ACR Open Rheumatology
title Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct‐to‐Family Pilot Trial
title_full Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct‐to‐Family Pilot Trial
title_fullStr Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct‐to‐Family Pilot Trial
title_full_unstemmed Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct‐to‐Family Pilot Trial
title_short Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct‐to‐Family Pilot Trial
title_sort effect of an electronic pill bottle on hydroxychloroquine adherence in pediatric lupus results of a novel direct to family pilot trial
url https://doi.org/10.1002/acr2.11780
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