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NCT Number: NCT06138184

Learning Theory Patient Education for Anticoagulants

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Anticoagulation Educational Materials

Behavioral

This includes new web-based patient educational materials that have been developed prior to the start of the study

Control Group: Standard of Care

Behavioral

This will be the current practice for patient education

Primary outcomes

  1. 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

Secondary outcomes

  1. Acceptability

    Time frame: 3 months

    High acceptability based on self-reported questionnaires using Likert questions per the Theoretical Framework of Acceptability domains

  2. Acceptability - Educational Tool

    Time frame: At time of intervention

    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

  3. Acceptability - Workflow Disruption

    Time frame: 18 months

    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

  4. Acceptability - Satisfaction

    Time frame: 3 months

    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.

  5. Acceptability - Intervention/Survey Fatigue

    Time frame: 3 months

    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

Other outcomes

  1. Patient knowledge

    Time frame: 3 months

    Anticoagulation Knowledge Test 28 item scale for patients taking warfarin or a direct oral anticoagulant to assess their knowledge , Minimum score = 0, Max score = 28. Higher scores indicate more knowledge

  2. Information overload

    Time frame: 3 months

    adapted Cancer Information Overload Scale 5-item scale from Strongly Disagree to Strongly Agree. Minimum score = 5, maximum score = 20. The higher the score indicates higher information overload.

  3. Adherence

    Time frame: 3 months

    Visual Analog Rating Scale (VAS) asks patients to estimate in a specified time period (the 3 months of the study period), the percentage of medication doses that they have taken as prescribed (0-100%) Higher percentage means higher adherence.

  4. Clinical outcomes

    Time frame: 3 months

    Patients will report the number (if any) of thromboembolic (stroke, deep vein thrombosis, pulmonary or systemic embolism), or bleeding events that they have had during the study period. We will also review patient charts to see if there are any reported events in the chart that are not reported by the patient. Bleeding events will be classified into major or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) definitions. We will also monitor for any deaths that may occur.

Study contacts

Contact information is provided by the study sponsor or research team.

Aubrey E Jones, PharmD, MSCI

CONTACT

[email protected]

801-587-9715

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Patient Education for Anticoagulants Using Learning Theories - a Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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