Health LiteracyeKITENCT03910933
Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative
An observational study of Health Literacy and Anticoagulation, run by University of Alberta at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Health Literacy, Anticoagulation
- What is being tested?
- elearning patient information
- How many people
- 150 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 30 Jun 2017to 10 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: English speaking children and their caregivers who initiate or require ongoing anticoaogulant therapy.
Who may be able to join
- Pediatric patients and their caregivers who are receiving treatment with anticoagulant therapy.
Who cannot join
- Non-english speaking patients.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Boston Children's Hospital
Boston, Massachusetts, 021115
Ann & Robert H Lurie Children's Hospital
Chicago, Illinois, 60611
Texas Children'Hospital
Houston, Texas, 77030
St. Louis Children's Hospital
St Louis, Missouri, 63110
Canada2 sites
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
Children's Hospital of Easter Ontario
Ottawa, Ontario, K1H 8L1
About this study
Official title: 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.
Read the 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.
- Warfarin international normalized ratio (INR) testing
- Warfarin with home INR testing
- Warfarin transition from home INR testing to warfarin self management.
- Conditions
- Health Literacy, Anticoagulation
- Being tested
- elearning patient information
- Keywords
- Warfarin, Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elearning patient informationOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
KIDCLOT What is an Anticoagulant Quiz1
Quiz to assess patient learning of important concepts related to anticoagulants
Measured: enrolment
KIDCLOT What is an Anticoagulant Quiz1
Quiz to assess change in patient knowledge of important concepts related to anticoagulants
Measured: 6 months and 18 months
Kidclot Warfarin Quiz 2
Quiz to assess patient learning of important concepts related to warfarin
Measured: enrolment
Kidclot Warfarin Quiz 2
Quiz to assess patient learning of important concepts related to warfarin
Measured: 6 months and 18 months
KIdclot INR testing Quiz 3
Quiz to assess patient learning of important concepts related to INR testing
Measured: enrolment
KIdclot INR testing Quiz 3
Quiz to assess change in patient knowledge of important concepts related to INR testing
Measured: 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
Measured: 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
Measured: 6 months and 18 months
Kidclot Home INR testing Quiz 5
Quiz to assess patient learning of important concepts related to home INR testing
Measured: enrolment
Kidclot Home INR testing Quiz 5
Quiz to assess change in patient knowledge of of important concepts related to home INR testing
Measured: 6 and 18 months
Kidclot Warfarin Self Management Quiz 6
Quiz to assess patient learning of important concepts related to Warfarin Self Management
Measured: 6 months
Kidclot Warfarin Self Management Quiz 6
Quiz to assess change in patient knowledge of of important concepts related to Warfarin Self Management
Measured: 18 months
Secondary outcomes (5)
Patient preference
Questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start30 Jun 2017
- Primary completion31 Oct 2020
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Bauman, MN, Principal investigator, Stollery Children's Hospital, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910933
- Sponsor's protocol ID
- Pro00074672
- Acronym
- eKITE
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2019
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EKITE: Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative
- ClinicalTrials.gov ID
- NCT03910933
- Acronym / sponsor ID
- eKITE / Pro00074672
- Conditions
- Health Literacy, Anticoagulation
- Keywords
- Warfarin, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- Warfarin international normalized ratio (INR) testing
- Warfarin with home INR testing
- Warfarin transition from home INR testing to warfarin self management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- English speaking children and their caregivers who initiate or require ongoing anticoaogulant therapy.
Key inclusion criteria (1 listed)
- Pediatric patients and their caregivers who are receiving treatment with anticoagulant therapy.
Key exclusion criteria (1 listed)
- Non-english speaking patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elearning patient informationThe 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). | Other | – |
Primary outcome
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
5 secondary outcomes
Patient preference
Time frame: enrolment
Stress Around Learning Score STAI-1
Time frame: enrolment
Stress Around Learning Score STAI-1
Time frame: enrolment
Pediatric Anticoagulation Quality of Life
Time frame: 6
Pediatric Anticoagulation Quality of Life
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Bauman, MN principal investigator
Stollery Children's Hospital, University of Alberta
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Literacy and Anticoagulation, run by University of Alberta at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KIDCLOT What is an Anticoagulant Quiz1 (time frame: enrolment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.