AnticoagulationNCT07129395
Anticoagulation Adherence Measurement Strategies
An observational study of Anticoagulation, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 29 years
- Conditions the study is for
- Anticoagulation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 4 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric, adolescents and young adults prescribed an anticoagulation medication.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Optimizing Measurement of Anticoagulation Adherence
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
Read the 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.
- Conditions
- Anticoagulation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
Rate barriers to adherence.
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.
Measured: 12 weeks
Self-reported barriers to adherence.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start9 Jan 2023
- Primary completion4 Oct 2024
- Study completion4 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Luchtman-Jones, MD, Principal investigator, Region V-East Great Lake Region, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129395
- Sponsor's protocol ID
- Anticoagulation Adherence
- Other IDs
- H30MC24047
- Status last verified
- Jul 2025
- First submitted
- 4 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andrew M, David M, Adams M, Ali K, Anderson R, Barnard D, Bernstein M, Brisson L, Cairney B, DeSai D, et al. Venous thromboembolic complications (VTE) in children: first analyses of the Canadian Registry of VTE. Blood. 1994 Mar 1;83(5):1251-7.
PubMed 8118029Gibson BES, Chalmers EA et al. Thromboembolism in childhood: a prospective 2-year BPSU study in the United Kingdom. February 2001-February 2003. Br J Haematol. 2004;1:OC422
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.
PubMed 11713446Raffini L, Huang YS, Witmer C, Feudtner C. Dramatic increase in venous thromboembolism in children's hospitals in the United States from 2001 to 2007. Pediatrics. 2009 Oct;124(4):1001-8. doi: 10.1542/peds.2009-0768. Epub 2009 Sep 7.
PubMed 19736261Kerlin BA. Current and future management of pediatric venous thromboembolism. Am J Hematol. 2012 May;87 Suppl 1(0 1):S68-74. doi: 10.1002/ajh.23131. Epub 2012 Feb 24.
PubMed 22367975Monagle P, Newall F. Management of thrombosis in children and neonates: practical use of anticoagulants in children. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):399-404. doi: 10.1182/asheducation-2018.1.399.
PubMed 30504338Monagle P, Chan AKC, Goldenberg NA, Ichord RN, Journeycake JM, Nowak-Gottl U, Vesely SK. Antithrombotic therapy in neonates and children: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e737S-e801S. doi: 10.1378/chest.11-2308.
PubMed 22315277Luchtman-Jones L. Venous thromboembolism and anticoagulation safety: who is watching the children? Pediatr Blood Cancer. 2014 Nov;61(11):1916-7. doi: 10.1002/pbc.25145. Epub 2014 Jul 22. No abstract available.
PubMed 25053292Jones S, McLoughlin S, Piovesan D, Savoia H, Monagle P, Newall F. Safety and Efficacy Outcomes of Home and Hospital Warfarin Management Within a Pediatric Anticoagulation Clinic. J Pediatr Hematol Oncol. 2016 Apr;38(3):216-20. doi: 10.1097/MPH.0000000000000502.
PubMed 26808370Simons LE, Blount RL. Identifying barriers to medication adherence in adolescent transplant recipients. J Pediatr Psychol. 2007 Aug;32(7):831-44. doi: 10.1093/jpepsy/jsm030. Epub 2007 May 23.
PubMed 17522111Modi 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.
PubMed 22218838Rapoff M. Adherence to pediatric medical regimens. 2nd ed. Issues in Clinical Child Psychology. New York, NY: Springer Science+Business Media; 2010
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.
PubMed 24829202Wu 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.
PubMed 29188741Quittner 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.
PubMed 17846042
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Measurement of Anticoagulation Adherence
- ClinicalTrials.gov ID
- NCT07129395
- Acronym / sponsor ID
- Anticoagulation Adherence
- Conditions
- Anticoagulation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric, adolescents and young adults prescribed an anticoagulation medication.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Rate barriers to adherence.
Time frame: 12 weeks
Self-reported barriers to adherence.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 8118029Andrew M, David M, Adams M, Ali K, Anderson R, Barnard D, Bernstein M, Brisson L, Cairney B, DeSai D, et al. Venous thromboembolic complications (VTE) in children: first analyses of the Canadian Registry of VTE. Blood. 1994 Mar 1;83(5):1251-7.
- BackgroundGibson BES, Chalmers EA et al. Thromboembolism in childhood: a prospective 2-year BPSU study in the United Kingdom. February 2001-February 2003. Br J Haematol. 2004;1:OC422
- Background: PubMed 11713446van 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.
- Background: PubMed 19736261Raffini L, Huang YS, Witmer C, Feudtner C. Dramatic increase in venous thromboembolism in children's hospitals in the United States from 2001 to 2007. Pediatrics. 2009 Oct;124(4):1001-8. doi: 10.1542/peds.2009-0768. Epub 2009 Sep 7.
- Background: PubMed 22367975Kerlin BA. Current and future management of pediatric venous thromboembolism. Am J Hematol. 2012 May;87 Suppl 1(0 1):S68-74. doi: 10.1002/ajh.23131. Epub 2012 Feb 24.
- Background: PubMed 30504338Monagle P, Newall F. Management of thrombosis in children and neonates: practical use of anticoagulants in children. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):399-404. doi: 10.1182/asheducation-2018.1.399.
- Background: PubMed 22315277Monagle P, Chan AKC, Goldenberg NA, Ichord RN, Journeycake JM, Nowak-Gottl U, Vesely SK. Antithrombotic therapy in neonates and children: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e737S-e801S. doi: 10.1378/chest.11-2308.
- Background: PubMed 25053292Luchtman-Jones L. Venous thromboembolism and anticoagulation safety: who is watching the children? Pediatr Blood Cancer. 2014 Nov;61(11):1916-7. doi: 10.1002/pbc.25145. Epub 2014 Jul 22. No abstract available.
- Background: PubMed 26808370Jones S, McLoughlin S, Piovesan D, Savoia H, Monagle P, Newall F. Safety and Efficacy Outcomes of Home and Hospital Warfarin Management Within a Pediatric Anticoagulation Clinic. J Pediatr Hematol Oncol. 2016 Apr;38(3):216-20. doi: 10.1097/MPH.0000000000000502.
- Background: PubMed 17522111Simons LE, Blount RL. Identifying barriers to medication adherence in adolescent transplant recipients. J Pediatr Psychol. 2007 Aug;32(7):831-44. doi: 10.1093/jpepsy/jsm030. Epub 2007 May 23.
- Background: PubMed 22218838Modi 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.
- BackgroundRapoff M. Adherence to pediatric medical regimens. 2nd ed. Issues in Clinical Child Psychology. New York, NY: Springer Science+Business Media; 2010
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Luchtman-Jones, MD principal investigator
Region V-East Great Lake Region, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure adherence via electronic adherence monitoring device (EAMD) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07129395, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.