Heart Failure Clinical Trial

Danger Signs in Heart Failure- Effects of Video Education

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.

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Full 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.

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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).

Study is for people with:

Heart Failure

Estimated Enrollment:

732

Study ID:

NCT03657459

Recruitment Status:

Completed

Sponsor:

The Cleveland Clinic

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There are 8 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

732

Study ID:

NCT03657459

Recruitment Status:

Completed

Sponsor:


The Cleveland Clinic

How clear is this clinincal trial information?

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