Danger Signs in Heart Failure- Effects of Video Education

Heart Failure; With Decompensation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657459
• Other study ID #: 18-442
• Status: Completed
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 732
• Est. completion date: May 31, 2022
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation

Intervention

Other:
• 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)

Locations

Country	Name	City	State
United States	Cleveland Clinic Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic main campus	Cleveland	Ohio
United States	Cleveland Clinic Marymount Hospital	Garfield Heights	Ohio
United States	Medical Center Navicent Health	Macon	Georgia
United States	Cleveland Clinic Hillcrest Hospital	Mayfield Heights	Ohio
United States	Cleveland Clinic Medina Hospital	Medina	Ohio
United States	Cleveland Clinic South Pointe Hospital	Warrensville Heights	Ohio
United States	WellSpan Health	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Wellflix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to 30 days
Secondary	First occurrence of HF-related hospitalization	First occurrence of post-discharge HF-related hospitalization	up to 30 days
Secondary	First occurrence of HF-related ED visit	First occurrence of post-discharge HF-related ED visit	up to 30 days
Secondary	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	up to 30 days
Secondary	First occurrence of HF-related hospitalization	First occurrence of post-discharge HF-related hospitalization	up to 180 days
Secondary	First occurrence of HF-related ED visit	First occurrence of post-discharge HF-related ED visit	up to 180 days
Secondary	First occurrence of HF-related death or cardiac transplant/VAD	First occurrence of post-discharge HF-related death or cardiac transplant/VAD	up to 180 days
Secondary	First occurrence of all-cause healthcare resource utilization (HCRU)	First occurrence of post-discharge all-cause HCRU (composite)	up to 30 days
Secondary	First occurrence of all-cause healthcare resource utilization (HCRU)	First occurrence of post-discharge all-cause HCRU (composite)	up to 180 days
Secondary	First occurrence of all-cause hospitalization	First occurrence of post-discharge HF-related hospitalization	up to 180 days
Secondary	First occurrence of all-cause ED visit	First occurrence of post-discharge HF-related ED visit	up to 180 days
Secondary	First occurrence of all-cause death or cardiac transplant/VAD	First occurrence of post-discharge HF-related death or cardiac transplant/VAD	up to 180 days
Secondary	Total all-cause healthcare resource utilization (HCRU)	Total post-discharge all-cause HCRU (composite)	up to 180 days
Secondary	Total HF-related healthcare resource utilization (HCRU)	Total post-discharge HF-related HCRU (composite)	up to 180 days
Secondary	Time to first occurrence of HF-related healthcare resource utilization (HCRU)	First occurrence of post-discharge HF-related HCRU (composite)	up to 180 days
Secondary	Time to first occurrence of HF-related hospitalization	First occurrence of post-discharge HF-related hospitalization	up to 180 days
Secondary	Time to first occurrence of HF-related ED visit	First occurrence of post-discharge HF-related ED visit	up to 180 days
Secondary	Time to first occurrence of HF-related death or cardiac transplantation/VAD	First occurrence of post-discharge HF-related death or cardiac transplantation/VAD	up to 180 days
Secondary	Time to first occurrence of all-cause healthcare resource utilization (HCRU)	First occurrence of post-discharge all-cause HCRU (composite)	up to 180 days
Secondary	Time to first occurrence of all-cause hospitalization	First occurrence of post-discharge HF-related hospitalization	up to 180 days
Secondary	Time to first occurrence of all-cause ED visit	First occurrence of post-discharge HF-related ED visit	180 days
Secondary	Time to first occurrence of all-cause death or cardiac transplantation/VAD	First occurrence of post-discharge HF-related death or cardiac transplantation/VAD	up to 180 days
Secondary	Change in Functional status from baseline	Change in Duke Activity Status Index (DASI) score from baseline	up to 180 ays
Secondary	Change in dyspnea from baseline	Change in PROMIS® Dyspnea Functional Limitations - Short Form 10a from baseline	up to 180 ays
Secondary	Change in fatigue from baseline	Change in a 10-item Fatigue Assessment Scale from baseline	up to 180 ays
Secondary	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	up to 180 ays
Secondary	Among intervention patients, HCRU based on all video views	Among intervention patients, differences in HCRU based on number of video views	30 days
Secondary	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	30 days
Secondary	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	30 days