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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

Tracking Information
First Submitted Date April 8, 2019
First Posted Date April 10, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date June 30, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2019)
  • KIDCLOT What is an Anticoagulant Quiz1 [ Time Frame: enrolment ]
    Quiz to assess patient learning of important concepts related to anticoagulants
  • 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
  • Kidclot Warfarin Quiz 2 [ Time Frame: enrolment ]
    Quiz to assess patient learning of important concepts related to warfarin
  • Kidclot Warfarin Quiz 2 [ Time Frame: 6 months and 18 months ]
    Quiz to assess patient learning of important concepts related to warfarin
  • KIdclot INR testing Quiz 3 [ Time Frame: enrolment ]
    Quiz to assess patient learning of important concepts related to INR testing
  • 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
  • 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
  • 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
  • Kidclot Home INR testing Quiz 5 [ Time Frame: enrolment ]
    Quiz to assess patient learning of important concepts related to home INR testing
  • 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
  • Kidclot Warfarin Self Management Quiz 6 [ Time Frame: 6 months ]
    Quiz to assess patient learning of important concepts related to Warfarin Self Management
  • 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
Original Primary Outcome Measures
 (submitted: April 8, 2019)
Patient knowledge [ Time Frame: 6 months ]
evaluated using the validated KIDCLOT knowledge quiz evaluating important concepts of anticoagulation therapy
Change History Complete list of historical versions of study NCT03910933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 11, 2019)
  • Patient preference [ Time Frame: enrolment ]
    Questionnaire
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 11, 2019)
  • Time in therapeutic Range [ Time Frame: 18 months ]
    Time INRs are within range
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative
Official Title EKITE: Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative
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.

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population English speaking children and their caregivers who initiate or require ongoing anticoaogulant therapy.
Condition
  • Health Literacy
  • Anticoagulation
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).
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 8, 2019)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-english speaking patients.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mary Bauman, MN, NP 7802485596 mary.bauman@ahs.ca
Contact: Cheri Robert, MSc 7802485611 cheri.robert@ahs.ca
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03910933
Other Study ID Numbers Pro00074672
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Alberta
Study Sponsor University of Alberta
Collaborators Not Provided
Investigators
Principal Investigator: Mary Bauman, MN Stollery Children's Hospital, University of Alberta
PRS Account University of Alberta
Verification Date March 2019