Danger Signs in Heart Failure- Effects of Video Education

NCT ID: NCT03657459

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 746 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2022-05-31

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.

Conditions

Heart Failure; With Decompensation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: ACTIVE_COMPARATOR

Danger Signs of Heart Failure Videos

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellflix, Inc.

UNKNOWN

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Nancy M. Albert, Ph.D.

Assocaite Chief Nursing Officer-Resaerch and Senior Nurse Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NANCY M. ALBERT, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Medical Center Navicent Health

Macon, Georgia, 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

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, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-442

Identifier Type: -

Identifier Source: org_study_id