ThromboembolismNCT02776566
Patient-Centered Anticoagulation Self-Monitoring in Minority Patients
A study testing Patient Self-Monitoring vs Anticoagulation Clinic in people with Thromboembolism and Blood Coagulation Disorders, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority underserved population. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Thromboembolism, Blood Coagulation Disorders, Cardiovascular Disease
- What is being tested?
- Patient Self-Monitoring vs Anticoagulation Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 21 years of age
- African American or Hispanic
- English speaking
- Has been on warfarin therapy > 3 months
- Plan to be on warfarin therapy > 12 months
- Willing ( or caregiver be willing) to do self-monitoring
- Willing to be randomized
Who cannot join
- Lack of access to a telephone
- Moderate to severe dementia (if lacks caregiver)
- Severe hearing impairment ( if lacks caregiver)
- Blindness ( if lacks caregiver)
- Life expectancy < 6 months
- Antiphospholipid antibody syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
The purpose of this study is to demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority underserved population.
Read the detailed description
Despite favorable results and enhanced patient convenience, the adoption of patient self-monitoring for anticoagulation therapy has been limited primarily to non-minority and higher socioeconomic status individuals. While effectiveness has been studied, the factors influencing the adoption of self-monitoring of anticoagulation in minorities with the most barriers to accessing quality care in specialized clinics, are not known.
Hypothesis: Patient centered education and training intervention for minority patients will result in effective adoption of self-monitoring of anticoagulation therapy, resulting in anticoagulation control of comparable quality to that seen in specialized anticoagulation clinic-based monitoring.
The research objective of this proposal will be accomplished through 3 specific aims:
- Identify patient and provider factors that influence adoption of anticoagulation self-monitoring in a minority population.
- Adapt and refine an education intervention that both addresses identified barriers and emphasizes identified positive influences to anticoagulation self-monitoring.
- Demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority population.
- Being tested
- Patient Self-Monitoring vs Anticoagulation Clinic
- Keywords
- Anticoagulation, Anticoagulation Management, Self-Testing, Self-Management, Warfarin, Thromboembolism, Blood Coagulation Disorders, Health Disparities, Minorities, African American, Hispanic, Cardiovascular Disease, Models of Anticoagulation Care, Tele-Health, Home Self-Testing
- Medical subject headings
- Thromboembolism, Blood Coagulation Disorders, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Self-Monitoring vs Anticoagulation ClinicOther
Patient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages.
Anticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation Clinic | Active comparator | Usual care through pharmacist managed anticoagulation clinic
Anticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic. Receives: Other: Patient Self-Monitoring vs Anticoagulation Clinic |
| Patient Self-Monitoring | Experimental | In home self-monitoring and pharmacist guided education
Patient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages. Receives: Other: Patient Self-Monitoring vs Anticoagulation Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent time in therapeutic range (TTR)
TTR will be calculated for each patient using the linear interpolation method. This method has been associated with clinical outcomes such as risk for thromboembolic events, and thus was selected over other methods of expressing the TTR such as fraction of International Normalized Ratio (INR) in range and cross-section of files
Measured: Month 1, Month 2, Month 4, Month 7
Secondary outcomes (5)
Treatment Related Quality of Life
It will be evaluated using a 25 item validated questionnaire that assesses limitations, hassles, and positive impact with a Cronbach alpha for each of 0.87, 0.88 and 0.78 respectively
Measured: Baseline, Month 1, Month 7
Anticoagulation Related Knowledge
It will be measured with an instrument containing 29 items at different levels of difficulty to allow differences in patient knowledge to be evaluated and has a person reliability coefficient of 0.75.
Measured: Baseline, Month 1, Month 7
Adherence with Monitoring
It is defined as the INR test completed within 24 hours of scheduled time and measured via the Coaguchek® device in home or clinic.
Measured: Month 1, Month 2, Month 4, Month 7
Self-Testing Competency (Intervention group only)
It is defined as the ability to attain an INR reading and provider observed technique.
Measured: Baseline to 7 months
Self-Testing Accuracy (Intervention group only)
It is defined as the concordance of self-reported and device-stored INR measurements.
Measured: Baseline to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Roche Pharma AG
- Responsible party
- Principal investigator, Edith A. Nutescu, University of Illinois Chicago
- Investigators
- Edith A Nutescu, PharmD, MS, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776566
- Sponsor's protocol ID
- 2015-1193
- Other IDs
- K23HL112908
- Status last verified
- Aug 2020
- First submitted
- 28 Mar 2016
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Anticoagulation Self-Monitoring in Minority Patients
- ClinicalTrials.gov ID
- NCT02776566
- Acronym / sponsor ID
- 2015-1193
- Keywords
- Anticoagulation, Anticoagulation Management, Self-Testing, Self-Management, Warfarin, Thromboembolism, Blood Coagulation Disorders, Health Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Roche Pharma AG
- Study start
- Jan 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 18 May 2016 (estimated)
- 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.
The purpose of this study is to demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority underserved population.
Detailed description
Despite favorable results and enhanced patient convenience, the adoption of patient self-monitoring for anticoagulation therapy has been limited primarily to non-minority and higher socioeconomic status individuals. While effectiveness has been studied, the factors influencing the adoption of self-monitoring of anticoagulation in minorities with the most barriers to accessing quality care in specialized clinics, are not known.
Hypothesis: Patient centered education and training intervention for minority patients will result in effective adoption of self-monitoring of anticoagulation therapy, resulting in anticoagulation control of comparable quality to that seen in specialized anticoagulation clinic-based monitoring.
The research objective of this proposal will be accomplished through 3 specific aims:
- Identify patient and provider factors that influence adoption of anticoagulation self-monitoring in a minority population.
- Adapt and refine an education intervention that both addresses identified barriers and emphasizes identified positive influences to anticoagulation self-monitoring.
- Demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation Clinic | Active comparator | Other: Patient Self-Monitoring vs Anticoagulation ClinicUsual care through pharmacist managed anticoagulation clinic Anticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic. |
| Patient Self-Monitoring | Experimental | Other: Patient Self-Monitoring vs Anticoagulation ClinicIn home self-monitoring and pharmacist guided education Patient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- > 21 years of age
- African American or Hispanic
- English speaking
- Has been on warfarin therapy > 3 months
- Plan to be on warfarin therapy > 12 months
Key exclusion criteria (6 listed)
- Lack of access to a telephone
- Moderate to severe dementia (if lacks caregiver)
- Severe hearing impairment ( if lacks caregiver)
- Blindness ( if lacks caregiver)
- Life expectancy < 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Self-Monitoring vs Anticoagulation ClinicPatient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages. Anticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic. | Other | Anticoagulation Clinic, Patient Self-Monitoring |
Primary outcome
Percent time in therapeutic range (TTR)
Time frame: Month 1, Month 2, Month 4, Month 7
TTR will be calculated for each patient using the linear interpolation method. This method has been associated with clinical outcomes such as risk for thromboembolic events, and thus was selected over other methods of expressing the TTR such as fraction of International Normalized Ratio (INR) in range and cross-section of files
5 secondary outcomes
Treatment Related Quality of Life
Time frame: Baseline, Month 1, Month 7
Anticoagulation Related Knowledge
Time frame: Baseline, Month 1, Month 7
Adherence with Monitoring
Time frame: Month 1, Month 2, Month 4, Month 7
Self-Testing Competency (Intervention group only)
Time frame: Baseline to 7 months
Self-Testing Accuracy (Intervention group only)
Time frame: Baseline to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Edith A Nutescu, PharmD, MS principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Self-Monitoring vs Anticoagulation Clinic in people with Thromboembolism and Blood Coagulation Disorders, run by University of Illinois Chicago 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 17 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent time in therapeutic range (TTR) (time frame: Month 1, Month 2, Month 4, Month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2020.