Danger Signs in Heart Failure- Effects of Video Education

NCT03657459 | Completed Results

• 1 other identifier: 18-442
• Study Type: interventional
• Target: 746
• Locations: 1 country
• Sites: 8

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.

Conditions

Heart Failure; With Decompensation

Keywords

video education; self care management; symptom recognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• Number of Participants With HF-related Hospitalization

  up to 30 days

• Number of Participants With HF-related ED Visits

  up to 30 days

• Number of Participants With HF-related Death

  up to 30 days

• Number of Participants With HF-related Healthcare Resource Utilization (HCRU)

  up to 90 days

• Number of Participants With HF-related Hospitalization

  up to 90 days

Study Arms (2)

usual care group

NO INTERVENTION

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

video education group

ACTIVE COMPARATOR

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

Interventions

Danger Signs of Heart Failure Videos 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

video education group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Please answer each question as it applies to you. Sex: 0.\_\_\_\_\_\_ Male 1.\_\_\_\_\_\_ Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Wellflix, Inc.: collaborator

Study Sites (8)

Medical Center Navicent Health

Macon, Georgia, 31201, United States

Location

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic main campus

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic Marymount Hospital

Garfield Heights, Ohio, 44125, United States

Location

Cleveland Clinic Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Cleveland Clinic Medina Hospital

Medina, Ohio, 44256, United States

Location

Cleveland Clinic South Pointe Hospital

Warrensville Heights, Ohio, 44122, United States

Location

WellSpan Health

York, Pennsylvania, 15198, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Nancy M. Albert PhD, CCNS, CHFN, CCRN, NE-BC, FAHA, FCCM, FHFSA, FAAN
• Organization: Cleveland Clinic

albertn@ccf.org

216-444-7028

Study Officials

• NANCY M. ALBERT, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Documentation of enrollment will not include group assignment Investigator will be blinded from group assignment via a separate excel file with that detail
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocaite Chief Nursing Officer-Resaerch and Senior Nurse Scientist

Model Details: Randomized, controlled prospective trial

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 5, 2018
• Study Start: July 26, 2018
• Primary Completion: October 20, 2021
• Study Completion: May 31, 2022
• Last Updated: May 7, 2025
• Results First Posted: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)