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Active, Not Recruiting

NCT Number: NCT07129395

Anticoagulation Adherence Measurement Strategies

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anticoagulation

Age range

Up to 29 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Measure adherence via electronic adherence monitoring device (EAMD)

    Time frame: 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 outcomes

  1. Rate barriers to adherence.

    Time frame: 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.

  2. Self-reported barriers to adherence.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Optimizing Measurement of Anticoagulation Adherence

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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