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Clinical Trials/NCT06232603
NCT06232603
Terminated
Not Applicable

Assessing Medication Adherence in Patients With Chronic Recurrent Multifocal Osteomyelitis

Seattle Children's Hospital1 site in 1 country9 target enrollmentFebruary 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Recurrent Multifocal Osteomyelitis
Sponsor
Seattle Children's Hospital
Enrollment
9
Locations
1
Primary Endpoint
Medication possession ratio (MPR)
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2024
End Date
June 18, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yongdong (Dan) Zhao

Associate professor, attending physician

Seattle Children's Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Medication possession ratio (MPR)

Time Frame: 6 to 9 months

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).

Secondary Outcomes

  • Barriers to adherence(6-9 months)

Study Sites (1)

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