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Active, not recruitingNCT03910933eKITEUpdated Sep 22, 2025

Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative

An observational study in Health Literacy and Anticoagulation, sponsored by University of Alberta. Active, not recruiting at 6 sites in 2 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by University of Alberta · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
248
Ages
Up to 18 Years
Sex
All
01

Study summary

Effective patient education improves health literacy and engagement thus improving long-term health outcomes. Health literacy is imperative to make informed health decisions and relies on the ability to obtain, process and understand health information; and is the cornerstone of safe health management. It is necessary to evaluate educational initiatives to determine their effectiveness in knowledge translation.

A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patient teaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required.

Electronic KITE teaching modules are infographic visual representations that present information quickly and clearly, integrating words and graphics to tell a story to reveal information. Infographic presentations are tools which facilitate self-directed learning with understandable, accessible information presented in an engaging way with an aim to enhance learning for children and their families. Patients are able to learn at a pace consistent with their learning style to facilitate knowledge development and health literacy.

Read the detailed description

A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patienteaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required.

Electronic KITE teaching modules are infographic visual representations that have been developed to provide patient teaching related to warfarin and its management.

How much patients have learned will be assessed using the KIDCLOT validated knowledge quizzes. Children 8 years and older to have cognitive capacity will complete the quizzes if able. Caregivers will complete all quizzes linked with the modules they have completed.

Patients may be enrolled into the appropriate cohort based on the health provider decision for management.

  1. Warfarin international normalized ratio (INR) testing
  2. Warfarin with home INR testing
  3. Warfarin transition from home INR testing to warfarin self management.
02

Conditions studied

  • Health Literacy
  • Anticoagulation

Keywords

  • Warfarin
  • Child
03

In context

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

English speaking children and their caregivers who initiate or require ongoing anticoaogulant therapy.

Inclusion criteria

  • Pediatric patients and their caregivers who are receiving treatment with anticoagulant therapy.

Exclusion criteria

Exclusion Criteria:

  • Non-english speaking patients.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
248 participants (actual)
Patient registry
No

Interventions

  • Otherelearning patient information

    The videos will standardize patient teaching about anticoagulants, warfarin, INR testing, and warfarin safety for Patient Self-Testing, and Patient Self-Management. eKITE, will provide a user-friendly interface to provide health education about anticoagulation. eKITE will teach concepts to the patient, facilitate sustained patient knowledge (6 month evaluation), reduce stress associated with learning, actively engage patients in their anticoagulant management (preference, satisfaction and knowledge).

06

What researchers measure

Primary outcomes

  1. KIDCLOT What is an Anticoagulant Quiz1

    Quiz to assess patient learning of important concepts related to anticoagulants

    Time frame: enrolment

  2. KIDCLOT What is an Anticoagulant Quiz1

    Quiz to assess change in patient knowledge of important concepts related to anticoagulants

    Time frame: 6 months and 18 months

  3. Kidclot Warfarin Quiz 2

    Quiz to assess patient learning of important concepts related to warfarin

    Time frame: enrolment

  4. Kidclot Warfarin Quiz 2

    Quiz to assess patient learning of important concepts related to warfarin

    Time frame: 6 months and 18 months

  5. KIdclot INR testing Quiz 3

    Quiz to assess patient learning of important concepts related to INR testing

    Time frame: enrolment

  6. KIdclot INR testing Quiz 3

    Quiz to assess change in patient knowledge of important concepts related to INR testing

    Time frame: 6 and 18 months

  7. Kidclot safety on an anticoagulant Quiz 4

    Quiz to assess patient learning of important concepts related to patient safety on an anticoagulant

    Time frame: enrolment

  8. Kidclot safety on an anticoagulant Quiz 4

    Quiz to assess change in patient knowledge of important concepts related to patient safety on an anticoagulant

    Time frame: 6 months and 18 months

  9. Kidclot Home INR testing Quiz 5

    Quiz to assess patient learning of important concepts related to home INR testing

    Time frame: enrolment

  10. Kidclot Home INR testing Quiz 5

    Quiz to assess change in patient knowledge of of important concepts related to home INR testing

    Time frame: 6 and 18 months

  11. Kidclot Warfarin Self Management Quiz 6

    Quiz to assess patient learning of important concepts related to Warfarin Self Management

    Time frame: 6 months

  12. Kidclot Warfarin Self Management Quiz 6

    Quiz to assess change in patient knowledge of of important concepts related to Warfarin Self Management

    Time frame: 18 months

Secondary outcomes

  1. Patient preference

    Questionnaire

    Time frame: enrolment

  2. Stress Around Learning Score STAI-1

    Survey to Assess patient stress around learning about warfarin and its management using the on-line modules. Measure of Calm.- Total score out of 40 with higher score indicates low stress and a positive outcome

    Time frame: enrolment

  3. Stress Around Learning Score STAI-1

    Survey to Assess patient stress around learning about warfarin and its management using the on-line modules. Total score out of 40. Measure of Worry- Total score out of 40 with lower score indicates low stress indicating a positive outcome

    Time frame: enrolment

  4. Pediatric Anticoagulation Quality of Life

    Quality of life score to assess impact of warfarin therapy on health related quality of life. Lower score indicates low impact. Score is a percentage

    Time frame: 6

  5. Pediatric Anticoagulation Quality of Life

    Quality of life score to assess any change in impact of warfarin therapy on health related quality of life. Lower score indicates low impact. Score is a percentage

    Time frame: 18 months

Other outcomes

  1. Time in therapeutic Range

    Time INRs are within range

    Time frame: 18 months

  2. Health care provider time associated with warfarin teaching

    Providers will measure and report the additional time spent providing patient teaching for warfarin management

    Time frame: enrolment, 6 months and 18 months

07

Study locations

6 sites
  • Ann & Robert H Lurie Children's Hospital
    Chicago, Illinois 60611, United States
  • Boston Children's Hospital
    Boston, Massachusetts 021115, United States
  • St. Louis Children's Hospital
    St Louis, Missouri 63110, United States
  • Texas Children'Hospital
    Houston, Texas 77030, United States
  • Stollery Children's Hospital
    Edmonton, Alberta T6G 2B7, Canada
  • Children's Hospital of Easter Ontario
    Ottawa, Ontario K1H 8L1, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03910933
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Apr 10, 2019
Start date
Jun 30, 2017
Primary completion
Oct 31, 2020
Completion
Dec 31, 2026 (estimated)
Last update
Sep 22, 2025

Study contacts

Mary Bauman, MN
principal investigator · Stollery Children's Hospital, University of Alberta

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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