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

NCT03910933 | Active Not Recruiting

• 1 other identifier: Pro00074672
• Study Type: observational
• Target: 248
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Health Literacy; Anticoagulation

Keywords

Warfarin; Child

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (5)

• Patient preference

  enrolment

• Stress Around Learning Score STAI-1

  enrolment

• Stress Around Learning Score STAI-1

  enrolment

• Pediatric Anticoagulation Quality of Life

  6

• Pediatric Anticoagulation Quality of Life

  18 months

Other Outcomes (2)

• Time in therapeutic Range

  18 months

• Health care provider time associated with warfarin teaching

  enrolment, 6 months and 18 months

Interventions

elearning patient information OTHER

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).

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Non-english speaking patients.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (6)

Ann & Robert H Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 021115, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Texas Children'Hospital

Houston, Texas, 77030, United States

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Children's Hospital of Easter Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Study Officials

• Mary Bauman, MN

  Stollery Children's Hospital, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: June 30, 2017
• Primary Completion: October 31, 2020
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (4)