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A Comparative Study on the Effectiveness of Video vs Text-Based Education in Heart Failure (EDUCATE-HF)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baseline questionnaires
Post-questionnaire
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Heart Failure Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Hospital & ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Video medication module then text self-monitoring module

Text medication module then video self-monitoring module

Video self-monitoring module then text medication module

Text self-monitoring module then video medication module

Arm Description

Patients are provided education via an online animated video on heart failure medications followed by a online text document on heart failure self-monitoring.

Patients are provided education via an online text document on heart failure medications followed by a online animated video on heart failure self-monitoring.

Patients are provided education via an online animated video on heart failure self-monitoring followed by a online text document on heart failure medications.

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.

Outcomes

Primary Outcome Measures

Heart Failure Knowledge Score Improvement
Change in percentage of correct answers on a questionnaire about heart failure knowledge regarding medications and self-management
Patient preference for heart failure education module
Likert scale of preference between video and text based modules

Secondary Outcome Measures

Change in HF medication score on knowledge assessment between video-based and text-based education modules
Change in percentage of correct answers on a questionnaire related to heart failure medications
Change in HF self-management score on knowledge assessment between video-based and text-based education modules
Change in percentage of correct answers on a questionnaire related to heart failure self-management
Change in self-assessed knowledge of HF medications between video-based and text-based education modules
Difference in Likert scale of self-assessed knowledge of HF medications before and after educational modules
Change in self-assessed knowledge of HF self-monitoring between video-based and text-based education modules
Difference in Likert scale of self-assessed knowledge of HF self-monitoring before and after educational modules

Full Information

First Posted
July 9, 2023
Last Updated
July 9, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05947799
Brief Title
A Comparative Study on the Effectiveness of Video vs Text-Based Education in Heart Failure
Acronym
EDUCATE-HF
Official Title
A Comparative Study on the Effectiveness of Video vs Text-Based Education in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Video medication module then text self-monitoring module
Arm Type
Other
Arm Description
Patients are provided education via an online animated video on heart failure medications followed by a online text document on heart failure self-monitoring.
Arm Title
Text medication module then video self-monitoring module
Arm Type
Other
Arm Description
Patients are provided education via an online text document on heart failure medications followed by a online animated video on heart failure self-monitoring.
Arm Title
Video self-monitoring module then text medication module
Arm Type
Other
Arm Description
Patients are provided education via an online animated video on heart failure self-monitoring followed by a online text document on heart failure medications.
Arm Title
Text self-monitoring module then video medication module
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Baseline questionnaires
Intervention Description
Questionnaires asking about the participant's familiarity with heart failure medication and management before watching/reading the educational modules.
Intervention Type
Other
Intervention Name(s)
Post-questionnaire
Intervention Description
Questionnaires asking about the participant's familiarity with heart failure medication and management after watching/reading the educational modules.
Primary Outcome Measure Information:
Title
Heart Failure Knowledge Score Improvement
Description
Change in percentage of correct answers on a questionnaire about heart failure knowledge regarding medications and self-management
Time Frame
Collected immediately following patient educational module completion
Title
Patient preference for heart failure education module
Description
Likert scale of preference between video and text based modules
Time Frame
Collected immediately following patient educational module completion
Secondary Outcome Measure Information:
Title
Change in HF medication score on knowledge assessment between video-based and text-based education modules
Description
Change in percentage of correct answers on a questionnaire related to heart failure medications
Time Frame
Collected immediately following patient educational module completion
Title
Change in HF self-management score on knowledge assessment between video-based and text-based education modules
Description
Change in percentage of correct answers on a questionnaire related to heart failure self-management
Time Frame
Collected immediately following patient educational module completion
Title
Change in self-assessed knowledge of HF medications between video-based and text-based education modules
Description
Difference in Likert scale of self-assessed knowledge of HF medications before and after educational modules
Time Frame
Collected immediately following patient educational module completion
Title
Change in self-assessed knowledge of HF self-monitoring between video-based and text-based education modules
Description
Difference in Likert scale of self-assessed knowledge of HF self-monitoring before and after educational modules
Time Frame
Collected immediately following patient educational module completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Sandhu, MD, MS
Phone
650 723-4000
Email
ats114@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Sandhu, MD, MS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital & Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander T Sandhu, MD, MS
Email
ats114@stanford.edu

12. IPD Sharing Statement

Learn more about this trial

A Comparative Study on the Effectiveness of Video vs Text-Based Education in Heart Failure

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