Medication Adherence Intervention in Chronic Recurrent Multifocal Osteomyelitis (CRMO)

NCT06232603 | Terminated

• 1 other identifier: STUDY00004426
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Recurrent Multifocal Osteomyelitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Barriers to adherence

  6-9 months

Study Arms (2)

Education at baseline

ACTIVE COMPARATOR

video and ambulatory visit summary (AVS) education will be provided at baseline visit

Other: Education of medication management

Education at the first follow up

OTHER

video and AVS education will be provided at the first follow up visit

Other: Education of medication management

Interventions

Education of medication management OTHER

Video and handout materials will be provided

Education at baseline; Education at the first follow up

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (5)

• 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.

  PMID: 35938626 BACKGROUND

• 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.

  PMID: 32183424 BACKGROUND

• 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.

  PMID: 29204970 BACKGROUND

• 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.

  PMID: 24504596 BACKGROUND

• 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.

  PMID: 29419467 BACKGROUND

MeSH Terms

Conditions

Chronic recurrent multifocal osteomyelitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, attending physician

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: January 31, 2024
• Study Start: February 20, 2024
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)