Danger Signs in Heart Failure- Effects of Video Education

Danger Signs of Worsening Heart Failure and Self-Management of Danger Signs: The Effects of Video Education

Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. Investigators will determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related HCRU.

Study Overview

• Status: Completed
• Conditions: Heart Failure; With Decompensation
• Intervention / Treatment: Behavioral: Danger Signs of Heart Failure Videos

Detailed Description

The most frequently cited danger signs of heart failure (HF) are new onset or worsening of fatigue, dyspnea and edema. In previous research, patients did not recognize worsening HF, due to 3 primary reasons: (1) danger signs were non-specific and misinterpreted as stress, an external force or another comorbidity, (2) danger signs were unrecognized due to the subtle nature of worsening status, or (3) when patients eliminated or minimized activities that prompted danger signs, they interpreted the results as improvement in status. Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. The purposes of this trial are to determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related health care resource utilization. The intervention will be administered during hospitalization, and patients and family members will receive a link to a website and a DVD to review videos as often as desired post-discharge. The primary end-point is 30-day HF-related hospitalization. 732 patients (658 + 10% attrition) with decompensated HF will be enrolled from multiple hospitals.

• Study Type: Interventional
• Enrollment (Actual): 746
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Macon, Georgia, United States, 31201
      • Medical Center Navicent Health
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Fairview Hospital
    • Garfield Heights, Ohio, United States, 44125
      • Cleveland Clinic Marymount Hospital
    • Mayfield Heights, Ohio, United States, 44124
      • Cleveland Clinic Hillcrest Hospital
    • Medina, Ohio, United States, 44256
      • Cleveland Clinic Medina Hospital
    • Warrensville Heights, Ohio, United States, 44122
      • Cleveland Clinic South Pointe Hospital
  • Pennsylvania
    • York, Pennsylvania, United States, 15198
      • WellSpan Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Not referred for cardiac transplantation or ventricular assist device placement during the index hospitalization,
• Cognitively intact and able to view videos (adequate eyesight and hearing) with correction, if needed,
• Discharge to home, assisted living facility or to a family member's home and can control dietary sodium and fluids as needed,
• Willing to participate; which may require up to three (3) follow-up telephone calls post-discharge.

Exclusion Criteria:

• Chart documented psychiatric or cognitive conditions that limit ability to understand video content or adhere to self-care recommendations (Alzheimer's condition, dementia, schizophrenia, other neurological history that impairs memory or concentration),
• Plans to discharge to skilled nursing facility or hospice care,
• Receiving home hospice or palliative care; or has a medical condition reflecting less than 1 year of survival (cachexia, end stage liver disease or cancer or non-ambulatory New York Heart Association functional class IV HF),
• Hospitalized but at admission, in New York Heart Association functional class I or II HF
• Post-cardiac transplantation or ventricular assist device placement,
• Currently enrolled in another experimental HF research study,
• Chronic renal failure and receiving chronic hemodialysis therapy for an estimated glomerular filtration rate < 15 mL/minute/1.73 m2,
• A non-traditional form of HF (hypertrophic or restrictive forms of cardiomyopathy, congenital heart disease or Takotsubo cardiomyopathy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care group; Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs
Active Comparator: video education group; Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)	Behavioral: Danger Signs of Heart Failure Videos; Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities) that reflect patient behaviors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)	Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.	up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With HF-related Hospitalization	Total number of participants post-discharge with HF-related hospitalization	up to 30 days
Number of Participants With HF-related ED Visits	Number of participants with post-discharge HF-related ED visits	up to 30 days
Number of Participants With HF-related Death	Number of participants post-discharge with HF-related death	up to 30 days
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)	Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.	up to 90 days
Number of Participants With HF-related Hospitalization	Number of participants post-discharge with HF-related hospitalization	up to 90 days
Number of Participants With HF-related ED Visit	Number of participants post-discharge with HF-related ED visit	up to 90 days
Number of Participants With HF-related Death	Number of participants post-discharge with HF-related death	up to 90 days
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)	Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.	up to 180 days
Number of Participants With HF-related Hospitalization	Number of participants post-discharge with HF-related hospitalization	up to 180 days
Number of Participants With HF-related ED Visit	Number of participants post-discharge with HF-related ED visit	up to 180 days
Number of Participants With HF-related Death	Number of participants post-discharge with HF-related death	up to 180 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)	Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.	up to 30 days
Number of Participants With All-cause Hospitalization	Number of participants post-discharge with all-cause hospitalization	up to 30 days
Number of Participants With All-cause ED Visits	Number of participants with post-discharge all-cause ED visits	30 days
Number of Participants With All-cause Death	Number of participants post-discharge with all-cause deaths	up to 30 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)	Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.	up to 90 days
Number of Participants With All-cause Hospitalization	Number of participants with post-discharge all-cause hospitalization	up to 90 days
Number of Participants With All-cause ED Visits	Number of participants post-discharge with all-cause ED visits	up to 90 days
Number of Participants With All-cause Death	Number of participants post-discharge with all-cause death	up to 90 days
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)	Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.	up to 180 days
Number of Participants With All-cause Hospitalization	Number of participants post-discharge with all-cause hospitalization	up to 180 days
All-cause ED Visits at 180 Days	Number of participants post-discharge with all-cause ED visits	up to 180 days
All-cause Death at 180 Days Post Discharge	Number of participants post-discharge with all-cause death	up to 180 days
Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge	Duke Activity Status Index (DASI) score at 30 days. Patients completed the DASI, a 12-item questionnaire using a Likert-like scale that determines a patient's ability to participate in daily self-care activities including ambulation, housework, yard work, sexual relations, and recreational activities. A total score reflects functional status based on responses. The full range of scores is 0 (most severe functional impairment) to 58.2 (no functional impairment). There is no established cut-point for this scale. Positive, higher scores reflect a positive and better functional status.	up to 30 days
Dyspnea at 30 Days Post Discharge	PROMIS® Dyspnea Functional Limitations - Short Form 10a was used. It is a 10-item tool that measures dyspnea by asking 10 questions about the difficulty in completing activities in the past 7 days. Responses range from "0 = no difficulty" to "3 = much difficulty" and there is an option for "I did not do this in the past 7 days" - there were 5 response options in total. Minimum and maximum raw scores are 0-30. PROMIS T scores are standardized with scores around 50 (standard deviation of 10) equating to normal/average levels and scores above or below equating to heightening or lessening of the variable being measured. A 5 point change in score is considered significant. A table is used to translate the total raw score to T score for each participant.	30 days
Fatigue at 30 Days Post Discharge	10-item Fatigue Assessment Scale from baseline. The Fatigue Assessment Scale is a valid, reliable 10-item scale evaluating symptoms of chronic fatigue. It uses Likert-type response options ranging from 1 ("never") to 5 ("always"), with some items reverse scored. Total scores range from 10 (lowest level of fatigue) to 50 (highest level of fatigue).	to 30 days
Self-efficacy for Managing Symptoms at 30 Days Post Discharge	PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline. 8-item tool that ranges from 'I am not at all confident' to 'I am very confident" - higher scores equals higher self-efficacy. A mean score of 50 is the average score in the general population of U.S. with standard deviation of 10. A table is used to translate the total raw score to T score for each participant. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores (above 50) reflect better than average self-efficacy	30 days
Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)	Among intervention group participants, total number of all-cause events within 30 days of discharge, based on the number of times the patient watched the video education. Participant responses are grouped into two categories: Never watched vs. 1 or more times	30 days
Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no)	Total number of participants (video education group only), comparison of all-cause events within 30 days of discharge, based on family members watching the educational videos after the hospital (Yes/No).	30 days

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Wellflix, Inc.
• Investigators: Principal Investigator: NANCY M. ALBERT, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 2, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: video education; self care management; symptom recognition
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 18-442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share individual data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No