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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anticoagulation; Health Literacy
• Intervention / Treatment: Other: elearning patient information

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.

• Study Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Non-english speaking patients.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KIDCLOT What is an Anticoagulant Quiz1	Quiz to assess patient learning of important concepts related to anticoagulants	enrolment
KIDCLOT What is an Anticoagulant Quiz1	Quiz to assess change in patient knowledge of important concepts related to anticoagulants	6 months and 18 months
Kidclot Warfarin Quiz 2	Quiz to assess patient learning of important concepts related to warfarin	enrolment
Kidclot Warfarin Quiz 2	Quiz to assess patient learning of important concepts related to warfarin	6 months and 18 months
KIdclot INR testing Quiz 3	Quiz to assess patient learning of important concepts related to INR testing	enrolment
KIdclot INR testing Quiz 3	Quiz to assess change in patient knowledge of important concepts related to INR testing	6 and 18 months
Kidclot safety on an anticoagulant Quiz 4	Quiz to assess patient learning of important concepts related to patient safety on an anticoagulant	enrolment
Kidclot safety on an anticoagulant Quiz 4	Quiz to assess change in patient knowledge of important concepts related to patient safety on an anticoagulant	6 months and 18 months
Kidclot Home INR testing Quiz 5	Quiz to assess patient learning of important concepts related to home INR testing	enrolment
Kidclot Home INR testing Quiz 5	Quiz to assess change in patient knowledge of of important concepts related to home INR testing	6 and 18 months
Kidclot Warfarin Self Management Quiz 6	Quiz to assess patient learning of important concepts related to Warfarin Self Management	6 months
Kidclot Warfarin Self Management Quiz 6	Quiz to assess change in patient knowledge of of important concepts related to Warfarin Self Management	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preference	Questionnaire	enrolment
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	enrolment
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	enrolment
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	6
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	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in therapeutic Range	Time INRs are within range	18 months
Health care provider time associated with warfarin teaching	Providers will measure and report the additional time spent providing patient teaching for warfarin management	enrolment, 6 months and 18 months

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Mary Bauman, MN, Stollery Children's Hospital, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): October 31, 2020
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Child; Warfarin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Embolism and Thrombosis; Thrombosis; Thrombophilia
• Other Study ID Numbers: Pro00074672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No