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Danger Signs in Heart Failure- Effects of Video Education

Primary Purpose

Heart Failure; With Decompensation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Danger Signs of Heart Failure Videos
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure; With Decompensation focused on measuring video education, self care management, symptom recognition

Eligibility Criteria

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

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).

Sites / Locations

  • Medical Center Navicent Health
  • Cleveland Clinic Fairview Hospital
  • Cleveland Clinic main campus
  • Cleveland Clinic Marymount Hospital
  • Cleveland Clinic Hillcrest Hospital
  • Cleveland Clinic Medina Hospital
  • Cleveland Clinic South Pointe Hospital
  • WellSpan Health

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

usual care group

video education group

Arm Description

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

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)

Outcomes

Primary Outcome Measures

First occurrence of HF-related healthcare resource utilization (HCRU)
First occurrence of post-discharge HF-related HCRU: hospitalization, emergency department [ED) visits, death or cardiac transplantation/ ventricular assist device [VAD] implant (composite)

Secondary Outcome Measures

First occurrence of HF-related hospitalization
First occurrence of post-discharge HF-related hospitalization
First occurrence of HF-related ED visit
First occurrence of post-discharge HF-related ED visit
First occurrence of post-discharge HF-related death or cardiac transplantation /ventricular assist device placement
First occurrence of post-discharge HF-related death or cardiac transplant/VAD
First occurrence of HF-related hospitalization
First occurrence of post-discharge HF-related hospitalization
First occurrence of HF-related ED visit
First occurrence of post-discharge HF-related ED visit
First occurrence of HF-related death or cardiac transplant/VAD
First occurrence of post-discharge HF-related death or cardiac transplant/VAD
First occurrence of all-cause healthcare resource utilization (HCRU)
First occurrence of post-discharge all-cause HCRU (composite)
First occurrence of all-cause healthcare resource utilization (HCRU)
First occurrence of post-discharge all-cause HCRU (composite)
First occurrence of all-cause hospitalization
First occurrence of post-discharge HF-related hospitalization
First occurrence of all-cause ED visit
First occurrence of post-discharge HF-related ED visit
First occurrence of all-cause death or cardiac transplant/VAD
First occurrence of post-discharge HF-related death or cardiac transplant/VAD
Total all-cause healthcare resource utilization (HCRU)
Total post-discharge all-cause HCRU (composite)
Total HF-related healthcare resource utilization (HCRU)
Total post-discharge HF-related HCRU (composite)
Time to first occurrence of HF-related healthcare resource utilization (HCRU)
First occurrence of post-discharge HF-related HCRU (composite)
Time to first occurrence of HF-related hospitalization
First occurrence of post-discharge HF-related hospitalization
Time to first occurrence of HF-related ED visit
First occurrence of post-discharge HF-related ED visit
Time to first occurrence of HF-related death or cardiac transplantation/VAD
First occurrence of post-discharge HF-related death or cardiac transplantation/VAD
Time to first occurrence of all-cause healthcare resource utilization (HCRU)
First occurrence of post-discharge all-cause HCRU (composite)
Time to first occurrence of all-cause hospitalization
First occurrence of post-discharge HF-related hospitalization
Time to first occurrence of all-cause ED visit
First occurrence of post-discharge HF-related ED visit
Time to first occurrence of all-cause death or cardiac transplantation/VAD
First occurrence of post-discharge HF-related death or cardiac transplantation/VAD
Change in Functional status from baseline
Change in Duke Activity Status Index (DASI) score from baseline
Change in dyspnea from baseline
Change in PROMIS® Dyspnea Functional Limitations - Short Form 10a from baseline
Change in fatigue from baseline
Change in a 10-item Fatigue Assessment Scale from baseline
Change in self-efficacy for managing symptoms, from baseline
Change in PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline
Among intervention patients, HCRU based on all video views
Among intervention patients, differences in HCRU based on number of video views
Among intervention patients, HCRU based on video views with family in hospital
Among intervention patients, differences in HCRU based on video viewing with family (Y/N) in hospital
Among intervention patients, HCRU based on video views with family post hospital discharge
Among intervention patients, differences in HCRU based on video viewing with family (Y/N) post hospital discharge

Full Information

First Posted
August 30, 2018
Last Updated
August 11, 2022
Sponsor
The Cleveland Clinic
Collaborators
Wellflix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03657459
Brief Title
Danger Signs in Heart Failure- Effects of Video Education
Official Title
Danger Signs of Worsening Heart Failure and Self-Management of Danger Signs: The Effects of Video Education
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
October 20, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Wellflix, Inc.

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure; With Decompensation
Keywords
video education, self care management, symptom recognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled prospective trial
Masking
Care ProviderInvestigator
Masking Description
Documentation of enrollment will not include group assignment Investigator will be blinded from group assignment via a separate excel file with that detail
Allocation
Randomized
Enrollment
732 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care group
Arm Type
No Intervention
Arm Description
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
Arm Title
video education group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Danger Signs of Heart Failure Videos
Intervention Description
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)
Primary Outcome Measure Information:
Title
First occurrence of HF-related healthcare resource utilization (HCRU)
Description
First occurrence of post-discharge HF-related HCRU: hospitalization, emergency department [ED) visits, death or cardiac transplantation/ ventricular assist device [VAD] implant (composite)
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
First occurrence of HF-related hospitalization
Description
First occurrence of post-discharge HF-related hospitalization
Time Frame
up to 30 days
Title
First occurrence of HF-related ED visit
Description
First occurrence of post-discharge HF-related ED visit
Time Frame
up to 30 days
Title
First occurrence of post-discharge HF-related death or cardiac transplantation /ventricular assist device placement
Description
First occurrence of post-discharge HF-related death or cardiac transplant/VAD
Time Frame
up to 30 days
Title
First occurrence of HF-related hospitalization
Description
First occurrence of post-discharge HF-related hospitalization
Time Frame
up to 180 days
Title
First occurrence of HF-related ED visit
Description
First occurrence of post-discharge HF-related ED visit
Time Frame
up to 180 days
Title
First occurrence of HF-related death or cardiac transplant/VAD
Description
First occurrence of post-discharge HF-related death or cardiac transplant/VAD
Time Frame
up to 180 days
Title
First occurrence of all-cause healthcare resource utilization (HCRU)
Description
First occurrence of post-discharge all-cause HCRU (composite)
Time Frame
up to 30 days
Title
First occurrence of all-cause healthcare resource utilization (HCRU)
Description
First occurrence of post-discharge all-cause HCRU (composite)
Time Frame
up to 180 days
Title
First occurrence of all-cause hospitalization
Description
First occurrence of post-discharge HF-related hospitalization
Time Frame
up to 180 days
Title
First occurrence of all-cause ED visit
Description
First occurrence of post-discharge HF-related ED visit
Time Frame
up to 180 days
Title
First occurrence of all-cause death or cardiac transplant/VAD
Description
First occurrence of post-discharge HF-related death or cardiac transplant/VAD
Time Frame
up to 180 days
Title
Total all-cause healthcare resource utilization (HCRU)
Description
Total post-discharge all-cause HCRU (composite)
Time Frame
up to 180 days
Title
Total HF-related healthcare resource utilization (HCRU)
Description
Total post-discharge HF-related HCRU (composite)
Time Frame
up to 180 days
Title
Time to first occurrence of HF-related healthcare resource utilization (HCRU)
Description
First occurrence of post-discharge HF-related HCRU (composite)
Time Frame
up to 180 days
Title
Time to first occurrence of HF-related hospitalization
Description
First occurrence of post-discharge HF-related hospitalization
Time Frame
up to 180 days
Title
Time to first occurrence of HF-related ED visit
Description
First occurrence of post-discharge HF-related ED visit
Time Frame
up to 180 days
Title
Time to first occurrence of HF-related death or cardiac transplantation/VAD
Description
First occurrence of post-discharge HF-related death or cardiac transplantation/VAD
Time Frame
up to 180 days
Title
Time to first occurrence of all-cause healthcare resource utilization (HCRU)
Description
First occurrence of post-discharge all-cause HCRU (composite)
Time Frame
up to 180 days
Title
Time to first occurrence of all-cause hospitalization
Description
First occurrence of post-discharge HF-related hospitalization
Time Frame
up to 180 days
Title
Time to first occurrence of all-cause ED visit
Description
First occurrence of post-discharge HF-related ED visit
Time Frame
180 days
Title
Time to first occurrence of all-cause death or cardiac transplantation/VAD
Description
First occurrence of post-discharge HF-related death or cardiac transplantation/VAD
Time Frame
up to 180 days
Title
Change in Functional status from baseline
Description
Change in Duke Activity Status Index (DASI) score from baseline
Time Frame
up to 180 ays
Title
Change in dyspnea from baseline
Description
Change in PROMIS® Dyspnea Functional Limitations - Short Form 10a from baseline
Time Frame
up to 180 ays
Title
Change in fatigue from baseline
Description
Change in a 10-item Fatigue Assessment Scale from baseline
Time Frame
up to 180 ays
Title
Change in self-efficacy for managing symptoms, from baseline
Description
Change in PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline
Time Frame
up to 180 ays
Title
Among intervention patients, HCRU based on all video views
Description
Among intervention patients, differences in HCRU based on number of video views
Time Frame
30 days
Title
Among intervention patients, HCRU based on video views with family in hospital
Description
Among intervention patients, differences in HCRU based on video viewing with family (Y/N) in hospital
Time Frame
30 days
Title
Among intervention patients, HCRU based on video views with family post hospital discharge
Description
Among intervention patients, differences in HCRU based on video viewing with family (Y/N) post hospital discharge
Time Frame
30 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Please answer each question as it applies to you. Sex: 0.______ Male 1.______ Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NANCY M. ALBERT, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center Navicent Health
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Cleveland Clinic Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic main campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleveland Clinic Marymount Hospital
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
Cleveland Clinic Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Cleveland Clinic Medina Hospital
City
Medina
State/Province
Ohio
ZIP/Postal Code
44256
Country
United States
Facility Name
Cleveland Clinic South Pointe Hospital
City
Warrensville Heights
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
WellSpan Health
City
York
State/Province
Pennsylvania
ZIP/Postal Code
15198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plans to share individual data

Learn more about this trial

Danger Signs in Heart Failure- Effects of Video Education

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