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

Health Literacy Clinical Trial

— eKITE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03910933
• Other study ID #: Pro00074672
• Status: Active, not recruiting
• Start date: June 30, 2017
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: December 31, 2026
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-english speaking patients.

Related Conditions & MeSH terms

• Anticoagulation
• Health Literacy
• Thrombophilia
• Thrombosis

Intervention

Other:
• elearning 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).

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	Children's Hospital of Easter Ontario	Ottawa	Ontario
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Ann & Robert H Lurie Children's Hospital	Chicago	Illinois
United States	Texas Children'Hospital	Houston	Texas
United States	St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time in therapeutic Range	Time INRs are within range	18 months
Other	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
Primary	KIDCLOT What is an Anticoagulant Quiz1	Quiz to assess patient learning of important concepts related to anticoagulants	enrolment
Primary	KIDCLOT What is an Anticoagulant Quiz1	Quiz to assess change in patient knowledge of important concepts related to anticoagulants	6 months and 18 months
Primary	Kidclot Warfarin Quiz 2	Quiz to assess patient learning of important concepts related to warfarin	enrolment
Primary	Kidclot Warfarin Quiz 2	Quiz to assess patient learning of important concepts related to warfarin	6 months and 18 months
Primary	KIdclot INR testing Quiz 3	Quiz to assess patient learning of important concepts related to INR testing	enrolment
Primary	KIdclot INR testing Quiz 3	Quiz to assess change in patient knowledge of important concepts related to INR testing	6 and 18 months
Primary	Kidclot safety on an anticoagulant Quiz 4	Quiz to assess patient learning of important concepts related to patient safety on an anticoagulant	enrolment
Primary	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
Primary	Kidclot Home INR testing Quiz 5	Quiz to assess patient learning of important concepts related to home INR testing	enrolment
Primary	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
Primary	Kidclot Warfarin Self Management Quiz 6	Quiz to assess patient learning of important concepts related to Warfarin Self Management	6 months
Primary	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	Patient preference	Questionnaire	enrolment
Secondary	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
Secondary	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
Secondary	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
Secondary	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