Clinical trial NCT06232603: Medication Adherence Intervention in Chronic Recurrent Multifocal Osteomyelitis (CRMO)
Official title: Assessing Medication Adherence in Patients With Chronic Recurrent Multifocal Osteomyelitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Recurrent Multifocal Osteomyelitis
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2024-01-31
Enrollment: 9
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project aims to quantify and evaluate rates of non-adherence and barriers to medication adherence in pediatric patients with CRMO followed at Seattle Children's Hospital's robust CRMO program, which is the only clinical program in the Washington, Wyoming, Alaska, Montana, Idaho (WWAMI) region. This will be a stepped-wedge cluster-randomized trial, in which participants will be randomly assigned to one of two groups -- one which receives educational materials at the end of their first clinic visit, and the other which receives educational materials at the end of their second clinic visit. All participants will be given baseline surveys at the start of their first clinic visit, as well as follow-up surveys at the start of their second and third clinic visits. These surveys aim to evaluate rates of non-adherence and qualitative barriers to adherence, as well as efficacy of educational interventions in improving adherence rates.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CRMO
* Receives clinical care at Seattle Children's Hospital
* On one or more scheduled prescription medications

Exclusion Criteria:

-

Primary outcomes:
measure: Medication possession ratio (MPR)
timeFrame: 6 to 9 months
Secondary outcomes:
measure: Barriers to adherence
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
citation: Semo-Oz R, Wagner-Weiner L, Edens C, Zic C, One K, Saad N, Tesher M. Adherence to medication by adolescents and young adults with childhood-onset systemic lupus erythematosus. Lupus. 2022 Oct;31(12):1508-1515. doi: 10.1177/09612033221115974. Epub 2022 Aug 7.
citation: Verma T, Rohan J. Examination of Transition Readiness, Medication Adherence, and Resilience in Pediatric Chronic Illness Populations: A Pilot Study. Int J Environ Res Public Health. 2020 Mar 15;17(6):1905. doi: 10.3390/ijerph17061905.
citation: Saag KG, Bhatia S, Mugavero MJ, Singh JA. Taking an Interdisciplinary Approach to Understanding and Improving Medication Adherence. J Gen Intern Med. 2018 Feb;33(2):136-138. doi: 10.1007/s11606-017-4215-7. No abstract available.
citation: Len CA, Miotto e Silva VB, Terreri MT. Importance of adherence in the outcome of juvenile idiopathic arthritis. Curr Rheumatol Rep. 2014 Apr;16(4):410. doi: 10.1007/s11926-014-0410-2.
citation: Favier LA, Taylor J, Loiselle Rich K, Jones KB, Vora SS, Harris JG, Gottlieb BS, Robbins L, Lai JT, Lee T, Kohlheim M, Gill J, Bouslaugh L, Young A, Griffin N, Morgan EM, Modi AC. Barriers to Adherence in Juvenile Idiopathic Arthritis: A Multicenter Collaborative Experience and Preliminary Results. J Rheumatol. 2018 May;45(5):690-696. doi: 10.3899/jrheum.171087. Epub 2018 Feb 1.