Medication Adherence Intervention in Chronic Recurrent Multifocal Osteomyelitis (CRMO)

NCT ID: NCT06232603

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2024-06-18

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Recurrent Multifocal Osteomyelitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Education at baseline

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

Group Type ACTIVE_COMPARATOR

Education of medication management

Intervention Type OTHER

Video and handout materials will be provided

Education at the first follow up

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

Group Type OTHER

Education of medication management

Intervention Type OTHER

Video and handout materials will be provided

Interventions

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Education of medication management

Video and handout materials will be provided

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongdong (Dan) Zhao

Associate professor, attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 35938626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32183424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29204970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24504596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29419467 (View on PubMed)

Other Identifiers

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STUDY00004426

Identifier Type: -

Identifier Source: org_study_id

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