Danger Signs in Heart Failure- Effects of Video Education

Study Overview
=================
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.

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

Conditions
-----------------
Heart Failure; With Decompensation

Intervention / Treatment
-----------------
* Other: Danger Signs of Heart Failure Videos


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled prospective trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care group<br>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 | |
| Active Comparator: video education group<br>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) | Other: Danger Signs of Heart Failure Videos<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
video education, self care management, symptom recognition