Anticoagulation Adherence Measurement Strategies

NCT07129395 | Active Not Recruiting

• 2 other identifiers: Anticoagulation AdherenceH30MC24047
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Anticoagulation

Outcome Measures

Primary Outcomes (1)

• Measure adherence via electronic adherence monitoring device (EAMD)

  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.

  12 weeks

Secondary Outcomes (2)

• Rate barriers to adherence.

  12 weeks

• Self-reported barriers to adherence.

  12 weeks

Eligibility Criteria

• Age: Up to 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric, adolescents and young adults prescribed an anticoagulation medication.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (22)

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  BACKGROUND

• van Ommen CH, Heijboer H, Buller HR, Hirasing RA, Heijmans HS, Peters M. Venous thromboembolism in childhood: a prospective two-year registry in The Netherlands. J Pediatr. 2001 Nov;139(5):676-81. doi: 10.1067/mpd.2001.118192.

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  PMID: 17522111 BACKGROUND

• Modi AC, Pai AL, Hommel KA, Hood KK, Cortina S, Hilliard ME, Guilfoyle SM, Gray WN, Drotar D. Pediatric self-management: a framework for research, practice, and policy. Pediatrics. 2012 Feb;129(2):e473-85. doi: 10.1542/peds.2011-1635. Epub 2012 Jan 4.

  PMID: 22218838 BACKGROUND

• Rapoff M. Adherence to pediatric medical regimens. 2nd ed. Issues in Clinical Child Psychology. New York, NY: Springer Science+Business Media; 2010

  BACKGROUND

• Bhatia S, Landier W, Hageman L, Kim H, Chen Y, Crews KR, Evans WE, Bostrom B, Casillas J, Dickens DS, Maloney KW, Neglia JP, Ravindranath Y, Ritchey AK, Wong FL, Relling MV. 6MP adherence in a multiracial cohort of children with acute lymphoblastic leukemia: a Children's Oncology Group study. Blood. 2014 Oct 9;124(15):2345-53. doi: 10.1182/blood-2014-01-552166. Epub 2014 May 14.

  PMID: 24829202 BACKGROUND

• Wu YP, Stenehjem DD, Linder LA, Yu B, Parsons BG, Mooney R, Fluchel MN. Adherence to Oral Medications During Maintenance Therapy Among Children and Adolescents With Acute Lymphoblastic Leukemia: A Medication Refill Analysis. J Pediatr Oncol Nurs. 2018 Mar/Apr;35(2):86-93. doi: 10.1177/1043454217741877. Epub 2017 Nov 30.

  PMID: 29188741 BACKGROUND

• Quittner AL, Modi AC, Lemanek KL, Ievers-Landis CE, Rapoff MA. Evidence-based assessment of adherence to medical treatments in pediatric psychology. J Pediatr Psychol. 2008 Oct;33(9):916-36; discussion 937-8. doi: 10.1093/jpepsy/jsm064. Epub 2007 Sep 10.

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• Vrijens B, Antoniou S, Burnier M, de la Sierra A, Volpe M. Current Situation of Medication Adherence in Hypertension. Front Pharmacol. 2017 Mar 1;8:100. doi: 10.3389/fphar.2017.00100. eCollection 2017.

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• Riekert KA, Rand CS. Electronic monitoring of medication adherence: When is high-tech best? J Clin Psychol Med Settings. 2002;9:25-34

  BACKGROUND

• Chan AH, Harrison J, Black PN, Mitchell EA, Foster JM. Using electronic monitoring devices to measure inhaler adherence: a practical guide for clinicians. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):335-49.e1-5. doi: 10.1016/j.jaip.2015.01.024. Epub 2015 Apr 1.

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• McGrady ME, Holbein CE, Smith AW, Morrison CF, Hommel KA, Modi AC, Pai ALH, Ramsey RR. An Independent Evaluation of the Accuracy and Usability of Electronic Adherence Monitoring Devices. Ann Intern Med. 2018 Sep 18;169(6):419-422. doi: 10.7326/M17-3306. Epub 2018 May 22. No abstract available.

  PMID: 29800004 BACKGROUND

• McGrady ME, Ramsey RR. Using Electronic Monitoring Devices to Assess Medication Adherence: a Research Methods Framework. J Gen Intern Med. 2020 Sep;35(9):2707-2714. doi: 10.1007/s11606-020-05905-z. Epub 2020 May 21.

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• Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, Agoritsas T, Mistry N, Iorio A, Jack S, Sivaramalingam B, Iserman E, Mustafa RA, Jedraszewski D, Cotoi C, Haynes RB. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4.

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  PMID: 22294891 BACKGROUND

Study Officials

• Lori Luchtman-Jones, MD

  Region V-East Great Lake Region, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 19, 2025
• Study Start: January 9, 2023
• Primary Completion: October 4, 2024
• Study Completion (Estimated): October 4, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-07

Locations

US (1)