Clinical trial NCT03657459: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure; With Decompensation
Keywords: video education
self care management
symptom recognition
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Wellflix, Inc.
First posted: 2018-09-05
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled prospective trial
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
timeFrame: up to 30 days
Secondary outcomes:
measure: Number of Participants With HF-related Hospitalization
timeFrame: up to 30 days
measure: Number of Participants With HF-related ED Visits
timeFrame: up to 30 days
measure: Number of Participants With HF-related Death
timeFrame: up to 30 days
measure: Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
timeFrame: up to 90 days
measure: Number of Participants With HF-related Hospitalization
timeFrame: up to 90 days
measure: Number of Participants With HF-related ED Visit
timeFrame: up to 90 days
measure: Number of Participants With HF-related Death
timeFrame: up to 90 days
measure: Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
timeFrame: up to 180 days
measure: Number of Participants With HF-related Hospitalization
timeFrame: up to 180 days
measure: Number of Participants With HF-related ED Visit
timeFrame: up to 180 days
measure: Number of Participants With HF-related Death
timeFrame: up to 180 days
measure: Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
timeFrame: up to 30 days
measure: Number of Participants With All-cause Hospitalization
timeFrame: up to 30 days
measure: Number of Participants With All-cause ED Visits
timeFrame: 30 days
measure: Number of Participants With All-cause Death
timeFrame: up to 30 days
measure: Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
timeFrame: up to 90 days
measure: Number of Participants With All-cause Hospitalization
timeFrame: up to 90 days
measure: Number of Participants With All-cause ED Visits
timeFrame: up to 90 days
measure: Number of Participants With All-cause Death
timeFrame: up to 90 days
measure: Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
timeFrame: up to 180 days
measure: Number of Participants With All-cause Hospitalization
timeFrame: up to 180 days
measure: All-cause ED Visits at 180 Days
timeFrame: up to 180 days
measure: All-cause Death at 180 Days Post Discharge
timeFrame: up to 180 days
measure: Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge
timeFrame: up to 30 days
measure: Dyspnea at 30 Days Post Discharge
timeFrame: 30 days
measure: Fatigue at 30 Days Post Discharge
timeFrame: to 30 days
measure: Self-efficacy for Managing Symptoms at 30 Days Post Discharge
timeFrame: 30 days
measure: Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)
timeFrame: 30 days
measure: Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no)
timeFrame: 30 days
Other outcomes:
Locations:
city: Macon
country: United States
facility: Medical Center Navicent Health
state: Georgia
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic main campus
state: Ohio
city: Garfield Heights
country: United States
facility: Cleveland Clinic Marymount Hospital
state: Ohio
city: Mayfield Heights
country: United States
facility: Cleveland Clinic Hillcrest Hospital
state: Ohio
city: Medina
country: United States
facility: Cleveland Clinic Medina Hospital
state: Ohio
city: Warrensville Heights
country: United States
facility: Cleveland Clinic South Pointe Hospital
state: Ohio
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
Study officials:
affiliation: The Cleveland Clinic
name: NANCY M. ALBERT, PhD
role: PRINCIPAL_INVESTIGATOR
References: