Medication Adherence Intervention in Chronic Recurrent Multifocal Osteomyelitis (CRMO)

Chronic Recurrent Multifocal Osteomyelitis Clinical Trial

Official title:

Assessing Medication Adherence in Patients With Chronic Recurrent Multifocal Osteomyelitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232603
• Other study ID #: STUDY00004426
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Seattle Children's Hospital
• Contact: Eric Tham, MD
• Phone: 2069872000
• Email: osr[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Diagnosis of CRMO

• Receives clinical care at Seattle Children's Hospital

• On one or more scheduled prescription medications

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Chronic Recurrent Multifocal Osteomyelitis
• Osteomyelitis
• Recurrence

Intervention

Other:
• Education of medication management
Video and handout materials will be provided

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication possession ratio (MPR)	The MPR is reported as a percentage calculated as: (total prescription days of supply/ (last prescription date - the first prescription date)). For example, if a patient only filled a one-month prescription twice during 6 months, so only had 60 days of medications available during the 6 months, the MPR would be 33%. A MPR of =0.8 is generally accepted as good compliance.; The MPR data will be calculated for T0 and T1. In order to capture adequate data to calculate the MPR, refill data was acquired for 3 months prior to the beginning of the study (MPR T0) and for 3 months after T1 (MPR T1).	6 to 9 months
Secondary	Barriers to adherence	A survey will be conducted to determine the barriers predefined and any other barriers	6-9 months