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Not yet recruiting NCT06138184

Learning Theory Patient Education for Anticoagulants

No phase Interventional Knowledge, Attitudes, Practice

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anticoagulation Educational Materials, Control Group: Standard of Care.
Who it may be relevant to
Registry conditions: Knowledge, Attitudes, Practice. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Patient Education for Anticoagulants Using Learning Theories - a Pilot Study

Overview

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.

Interventions

  • Behavioral Anticoagulation Educational Materials
    This includes new web-based patient educational materials that have been developed prior to the start of the study
  • Behavioral Control Group: Standard of Care
    This will be the current practice for patient education

Primary outcome measures

  • Feasibility of implementing a randomized control trial [Time frame: 18 months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06138184 · IRB_00146488 · K23HL157751

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗