Learning Theory Patient Education for Anticoagulants

NCT06138184 | Not Yet Recruiting

• 2 other identifiers: IRB_00146488K23HL157751
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Knowledge, Attitudes, Practice

Keywords

anticoagulant; direct oral anticoagulant; vitamin k antagonist; warfarin; patient education; learning theory

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Secondary Outcomes (5)

• Acceptability

  3 months

• Acceptability - Educational Tool

  At time of intervention

• Acceptability - Workflow Disruption

  18 months

• Acceptability - Satisfaction

  3 months

• Acceptability - Intervention/Survey Fatigue

  3 months

Other Outcomes (4)

• Patient knowledge

  3 months

• Information overload

  3 months

• Adherence

  3 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Standard Educational process

Behavioral: Control Group: Standard of Care

Education Intervention

EXPERIMENTAL

New educational intervention

Behavioral: Anticoagulation Educational Materials

Interventions

Anticoagulation Educational Materials BEHAVIORAL

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

Education Intervention

Control Group: Standard of Care BEHAVIORAL

This will be the current practice for patient education

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Behavior

Study Officials

• Aubrey E Jones, PharmD, MSCI

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aubrey E Jones, PharmD, MSCI

CONTACT

801-587-9715; aubrey.e.jones@pharm.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: November 18, 2023
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12