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

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

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Hospital & Clinics
        • Contact:

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.

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

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.

Clinical Trials on Heart Failure

Clinical Trials on Baseline questionnaires

3
Subscribe