Knowledge, Attitudes, PracticeNCT06138184
Learning Theory Patient Education for Anticoagulants
A study testing Anticoagulation Educational Materials in people with Knowledge, Attitudes, Practice, run by University of Utah.
Trial summary
The goal of this study is to test the feasibility of a randomized control trial evaluating the educational tool for anticoagulated patients. Participants will be randomized to use new educational materials or current existing educational materials and answer survey questions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- Anticoagulation Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- initiating (naïve) or currently taking (experienced) oral anticoagulants with an anticipated treatment duration of at least three months
- Experienced patients will be eligible if they score less than 75% on the Anticoagulation Knowledge Test
Who cannot join
- Deficits in cognitive abilities, sensory input, or language significant enough to impede their use of the education tool and/or provision of written informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient Education for Anticoagulants Using Learning Theories - a Pilot Study
The goal of this study is to test the feasibility of a randomized control trial evaluating the educational tool for anticoagulated patients.
Participants will be randomized to use new educational materials or current existing educational materials and answer survey questions.
Read the detailed description
Eligible patients will be randomized using stratified block randomization to control for the type of anticoagulant (warfarin vs. DOAC) and status (naïve vs. experienced) to either the education intervention from Aim 2 or standard of care Data will be collected via online surveys before the intervention, immediately after, and then 3 months after the intervention.
Patients at the University of Utah Thrombosis Clinic will be recruited.
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- Anticoagulation Educational Materials, Control Group: Standard of Care
- Keywords
- anticoagulant, direct oral anticoagulant, vitamin k antagonist, warfarin, patient education, learning theory
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation Educational MaterialsBehavioural
This includes new web-based patient educational materials that have been developed prior to the start of the study
Control Group: Standard of CareBehavioural
This will be the current practice for patient education
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Standard Educational process Receives: Behavioral: Control Group: Standard of Care |
| Education Intervention | Experimental | New educational intervention Receives: Behavioral: Anticoagulation Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing a randomized control trial
The study will be feasible if 1) the consent rate if 5 patients per month, 2) Proportion of patients completing the educational tool is 90%; 3) Loss to follow-up at three months is 20% or less
Measured: 18 months
Secondary outcomes (5)
Acceptability
High acceptability based on self-reported questionnaires using Likert questions per the Theoretical Framework of Acceptability domains
Measured: 3 months
Acceptability - Educational Tool
This will be measured using an adapted version of the Ottawa Decision Aid Acceptability Measures which is a 10-question tool shortened to 5 questions that assess: 1) The way information is presented, 2) Length of the Materials, 3) Amount of information, 4) What was liked, and 5) Suggestions for improvement
Measured: At time of intervention
Acceptability - Workflow Disruption
2 questions to providers asking to rate how much a) the study disrupted their workflow and b) how much the educational tool disrupted their workflow on a scale from 1- Very disruptive to 5 - Not all disruptive. Higher scores are better outcomes
Measured: 18 months
Acceptability - Satisfaction
Patients and providers will both complete a 5 point Likert scale asking how satisfied they are with the educational materials, with 1 being Very dissatisfied and 5 being Very Satisfied.
Measured: 3 months
Acceptability - Intervention/Survey Fatigue
1 question measuring survey fatigue: 1) the length of surveys was a) too long, b) too short, c) just right and the number of surveys that were not filled out/not completed. If the majority of surveys are not completed or started, and the majority of patients answer that the length of surveys was too long, that will indicate high survey fatigue
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Aubrey E. Jones, University of Utah
- Investigators
- Aubrey E Jones, PharmD, MSCI, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138184
- Sponsor's protocol ID
- IRB_00146488
- Other IDs
- K23HL157751
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education for Anticoagulants Using Learning Theories - a Pilot Study
- ClinicalTrials.gov ID
- NCT06138184
- Acronym / sponsor ID
- IRB_00146488
- Conditions
- Knowledge, Attitudes, Practice
- Keywords
- anticoagulant, direct oral anticoagulant, vitamin k antagonist, warfarin, patient education, learning theory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 2023 (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.
The goal of this study is to test the feasibility of a randomized control trial evaluating the educational tool for anticoagulated patients.
Participants will be randomized to use new educational materials or current existing educational materials and answer survey questions.
Detailed description
Eligible patients will be randomized using stratified block randomization to control for the type of anticoagulant (warfarin vs. DOAC) and status (naïve vs. experienced) to either the education intervention from Aim 2 or standard of care Data will be collected via online surveys before the intervention, immediately after, and then 3 months after the intervention.
Patients at the University of Utah Thrombosis Clinic will be recruited.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Control Group: Standard of CareStandard Educational process |
| Education Intervention | Experimental | Behavioral: Anticoagulation Educational MaterialsNew educational intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- initiating (naïve) or currently taking (experienced) oral anticoagulants with an anticipated treatment duration of at least three months
- Experienced patients will be eligible if they score less than 75% on the Anticoagulation Knowledge Test
Key exclusion criteria (1 listed)
- Deficits in cognitive abilities, sensory input, or language significant enough to impede their use of the education tool and/or provision of written informed consent
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 |
|---|---|---|
| Anticoagulation Educational MaterialsThis includes new web-based patient educational materials that have been developed prior to the start of the study | Behavioural | Education Intervention |
| Control Group: Standard of CareThis will be the current practice for patient education | Behavioural | Standard Care |
Primary outcome
Feasibility of implementing a randomized control trial
Time frame: 18 months
The study will be feasible if 1) the consent rate if 5 patients per month, 2) Proportion of patients completing the educational tool is 90%; 3) Loss to follow-up at three months is 20% or less
5 secondary outcomes
Acceptability
Time frame: 3 months
Acceptability - Educational Tool
Time frame: At time of intervention
Acceptability - Workflow Disruption
Time frame: 18 months
Acceptability - Satisfaction
Time frame: 3 months
Acceptability - Intervention/Survey Fatigue
Time frame: 3 months
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 17 Dec 2025.
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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.
Aubrey E Jones, PharmD, MSCI principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulation Educational Materials in people with Knowledge, Attitudes, Practice, run by University of Utah.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Aubrey E Jones, PharmD, MSCI (801-587-9715, aubrey.e.jones@pharm.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing a randomized control trial (time frame: 18 months). 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 Dec 2025.