Anticoagulation Adherence Measurement Strategies

Active, not recruiting

• Conditions: Anticoagulation

• Registration Number: NCT07129395
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Single center study to evaluate the feasibility of using 3 different strategies to measure adherence among children, adolescents, and young adults prescribed an anticoagulation medication

Detailed Description

This is an observational study with a maximum of 5 study visits during the 12-week study period. The study visit schedule has been designed to align with current clinical care practices. Adherence will be assessed via the EAMDs device, as well as by self-report measure in the BAT and by staff telephone inquiry regarding pharmacy refill data. Adherence data will be used to compute rates and trajectories of adherence to anticoagulants.

It is anticipated that this study will conclude in approximately 2 years, including data analysis.

Study Timeline

• Study Start: 2023-01-09
• Primary Completion: 2024-10-04
• Status Verified: 2025-07
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Completion: 2026-10-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Anticoagulated CCHMC patients ages 0 to 29.9 years and their caregivers (where applicable for patients < 18 years)
• Able to provide informed consent
• Duration of anticoagulation planned for the outpatient setting is 4 weeks or longer
• Willing and able to participate in telephone and in person study visits
• For patients < 18 years, both patient and caregiver agree to participate

Exclusion Criteria

• Unwilling or unable to provide informed consent
• Duration of anticoagulation is planned for < 4 weeks in the outpatient setting
• Anticoagulant drug will not fit into the EAMD
• Unable to participate in telephone study visit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure adherence via electronic adherence monitoring device (EAMD)	12 weeks	Participants will be provided with a MEMS® Cap if they are prescribed an oral medication and a MEMS® Injectable if they are prescribed an injectable medication. Patients and families will then be trained by study nurse coordinator (NC) or principal investigator (PI) regarding how to use the MEMS® for medication administration throughout the study.

Secondary Outcome Measures

Name	Time	Method
Self-reported barriers to adherence.	12 weeks	Characterize the self-reported barriers to adherence in a sample of children and adolescents and young adults prescribed anticoagulants using data from three different adherence measurements.
Rate barriers to adherence.	12 weeks	Characterize the rate of barriers to adherence in a sample of children and adolescents and young adults prescribed anticoagulants using data from three different adherence measurements.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States