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

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ClinicalTrials.gov Identifier: NCT03910933
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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, 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 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.


Condition or disease Intervention/treatment
Health Literacy Anticoagulation 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 INR testing
  2. Warfarin with home INR testing
  3. Warfarin transition from home INR testing to warfarin self management.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EKITE: Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2021



Intervention Details:
  • 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).


Primary Outcome Measures :
  1. KIDCLOT What is an Anticoagulant Quiz1 [ Time Frame: enrolment ]
    Quiz to assess patient learning of important concepts related to anticoagulants

  2. KIDCLOT What is an Anticoagulant Quiz1 [ Time Frame: 6 months and 18 months ]
    Quiz to assess change in patient knowledge of important concepts related to anticoagulants

  3. Kidclot Warfarin Quiz 2 [ Time Frame: enrolment ]
    Quiz to assess patient learning of important concepts related to warfarin

  4. Kidclot Warfarin Quiz 2 [ Time Frame: 6 months and 18 months ]
    Quiz to assess patient learning of important concepts related to warfarin

  5. KIdclot INR testing Quiz 3 [ Time Frame: enrolment ]
    Quiz to assess patient learning of important concepts related to INR testing

  6. KIdclot INR testing Quiz 3 [ Time Frame: 6 and 18 months ]
    Quiz to assess change in patient knowledge of important concepts related to INR testing

  7. Kidclot safety on an anticoagulant Quiz 4 [ Time Frame: enrolment ]
    Quiz to assess patient learning of important concepts related to patient safety on an anticoagulant

  8. Kidclot safety on an anticoagulant Quiz 4 [ Time Frame: 6 months and 18 months ]
    Quiz to assess change in patient knowledge of important concepts related to patient safety on an anticoagulant

  9. Kidclot Home INR testing Quiz 5 [ Time Frame: enrolment ]
    Quiz to assess patient learning of important concepts related to home INR testing

  10. Kidclot Home INR testing Quiz 5 [ Time Frame: 6 and 18 months ]
    Quiz to assess change in patient knowledge of of important concepts related to home INR testing

  11. Kidclot Warfarin Self Management Quiz 6 [ Time Frame: 6 months ]
    Quiz to assess patient learning of important concepts related to Warfarin Self Management

  12. Kidclot Warfarin Self Management Quiz 6 [ Time Frame: 18 months ]
    Quiz to assess change in patient knowledge of of important concepts related to Warfarin Self Management


Secondary Outcome Measures :
  1. Patient preference [ Time Frame: enrolment ]
    Questionnaire

  2. Stress Around Learning Score STAI-1 [ Time Frame: enrolment ]
    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

  3. Stress Around Learning Score STAI-1 [ Time Frame: enrolment ]
    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

  4. Pediatric Anticoagulation Quality of Life [ Time Frame: 6 ]
    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

  5. Pediatric Anticoagulation Quality of Life [ Time Frame: 18 months ]
    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


Other Outcome Measures:
  1. Time in therapeutic Range [ Time Frame: 18 months ]
    Time INRs are within range

  2. Health care provider time associated with warfarin teaching [ Time Frame: enrolment, 6 months and 18 months ]
    Providers will measure and report the additional time spent providing patient teaching for warfarin management



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-english speaking patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910933


Contacts
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Contact: Mary Bauman, MN, NP 7802485596 mary.bauman@ahs.ca
Contact: Cheri Robert, MSc 7802485611 cheri.robert@ahs.ca

Locations
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United States, Illinois
Ann & Robert H Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Rukhmi Bhat, MD    312-227-4833    RBhat@luriechildrens.org   
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 021115
Contact: Christina VanDerPluym, MD    617-355-3793      
United States, Missouri
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Cantor Charles, MD    314-454-3798      
United States, Texas
Texas Children'Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Donald Yee    832-822-1541      
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Mary Bauman    7802485596    mary.bauman@ahs.ca   
Contact: Cheri Robert    7802485611    cheri.robert@ahs.ca   
Canada, Ontario
Children's Hospital of Easter Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Ewurbena Simpson, MD    613-737-7600    esimpson@cheo.on.ca   
Principal Investigator: Ewurbena Simpson, MD         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Mary Bauman, MN Stollery Children's Hospital, University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03910933     History of Changes
Other Study ID Numbers: Pro00074672
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Warfarin
Child
Additional relevant MeSH terms:
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Thrombosis
Thrombophilia
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Warfarin
Anticoagulants