- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05947799
A Comparative Study on the Effectiveness of Video vs Text-Based Education in Heart Failure (EDUCATE-HF)
July 9, 2023 updated by: Alexander Sandhu, Stanford University
This is a study seeking to compare the change in overall heart failure (HF) knowledge score and participant preference between video-based and text-based HF education modules.
Participants will be randomized to watching and reading different combinations of video-based education modules and text-based education modules.
Participants will be asked to answer questions about their familiarity with heart failure medications and management before and after the said education modules.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study compares the change in heart failure (HF) knowledge and participant preference between video-based and text-based HF education modules.
Educational material regarding two different topics - heart failure self-monitoring and medication management - has been developed in two different formats: animated educational videos and text-based documents.
Both formats contain the same information.
In this study, participants will be randomized to either watching or reading different combinations of the education for these two topics to better understand which educational tool - animated videos or text-based - is preferred by participants and leads to greater educational attainment.
Educational attainment is evaluated by pre and post questions about both topics.
Study Type
Interventional
Enrollment (Estimated)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexander Sandhu, MD, MS
- Phone Number: 650 723-4000
- Email: ats114@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford Hospital & Clinics
-
Contact:
- Alexander T Sandhu, MD, MS
- Email: ats114@stanford.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants with heart failure with reduced ejection fraction (EF ≤40%)
Exclusion Criteria:
- Participants who have the inability to independently read or answer written questions in English and are non-conversant in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Video medication module then text self-monitoring module
Patients are provided education via an online animated video on heart failure medications followed by a online text document on heart failure self-monitoring.
|
Questionnaires asking about the participant's familiarity with heart failure medication and management before watching/reading the educational modules.
Questionnaires asking about the participant's familiarity with heart failure medication and management after watching/reading the educational modules.
|
Other: Text medication module then video self-monitoring module
Patients are provided education via an online text document on heart failure medications followed by a online animated video on heart failure self-monitoring.
|
Questionnaires asking about the participant's familiarity with heart failure medication and management before watching/reading the educational modules.
Questionnaires asking about the participant's familiarity with heart failure medication and management after watching/reading the educational modules.
|
Other: Video self-monitoring module then text medication module
Patients are provided education via an online animated video on heart failure self-monitoring followed by a online text document on heart failure medications.
|
Questionnaires asking about the participant's familiarity with heart failure medication and management before watching/reading the educational modules.
Questionnaires asking about the participant's familiarity with heart failure medication and management after watching/reading the educational modules.
|
Other: Text self-monitoring module then video medication module
Patients are provided education via an online text document on heart failure self-monitoring followed by a online animated video on heart failure medication management.
|
Questionnaires asking about the participant's familiarity with heart failure medication and management before watching/reading the educational modules.
Questionnaires asking about the participant's familiarity with heart failure medication and management after watching/reading the educational modules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Failure Knowledge Score Improvement
Time Frame: Collected immediately following patient educational module completion
|
Change in percentage of correct answers on a questionnaire about heart failure knowledge regarding medications and self-management
|
Collected immediately following patient educational module completion
|
Patient preference for heart failure education module
Time Frame: Collected immediately following patient educational module completion
|
Likert scale of preference between video and text based modules
|
Collected immediately following patient educational module completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HF medication score on knowledge assessment between video-based and text-based education modules
Time Frame: Collected immediately following patient educational module completion
|
Change in percentage of correct answers on a questionnaire related to heart failure medications
|
Collected immediately following patient educational module completion
|
Change in HF self-management score on knowledge assessment between video-based and text-based education modules
Time Frame: Collected immediately following patient educational module completion
|
Change in percentage of correct answers on a questionnaire related to heart failure self-management
|
Collected immediately following patient educational module completion
|
Change in self-assessed knowledge of HF medications between video-based and text-based education modules
Time Frame: Collected immediately following patient educational module completion
|
Difference in Likert scale of self-assessed knowledge of HF medications before and after educational modules
|
Collected immediately following patient educational module completion
|
Change in self-assessed knowledge of HF self-monitoring between video-based and text-based education modules
Time Frame: Collected immediately following patient educational module completion
|
Difference in Likert scale of self-assessed knowledge of HF self-monitoring before and after educational modules
|
Collected immediately following patient educational module completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander Sandhu, MD, MS, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2023
Primary Completion (Estimated)
March 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
July 9, 2023
First Submitted That Met QC Criteria
July 9, 2023
First Posted (Actual)
July 17, 2023
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 9, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69691
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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