Anticoagulation Adherence Measurement Strategies

Cincinnati Children's Hospital Medical Center

Status: Active, not recruiting

Conditions: Anticoagulation

Study type: Observational

Funder types: Other

Identifiers

NCT07129395

Anticoagulation Adherence

H30MC24047 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: Under 29 years old

Volunteers: No Healthy Volunteers

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