Danger Signs in Heart Failure- Effects of Video Education

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03657459

Collaborator

Wellflix, Inc. (Other)

732

Enrollment

Locations

Arms

46.2

Actual Duration (Months)

91.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; With Decompensation	Other: Danger Signs of Heart Failure Videos	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

732 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, controlled prospective trialRandomized, controlled prospective trial

Masking:

Double (Care Provider, Investigator)

Masking Description:

Documentation of enrollment will not include group assignment Investigator will be blinded from group assignment via a separate excel file with that detail

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 26, 2018

Actual Primary Completion Date :

Oct 20, 2021

Actual Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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
Active Comparator: 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)	Other: 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)

Arm

Intervention/Treatment

No Intervention: 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

Active Comparator: 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)

Other: 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)

Outcome Measures

Primary Outcome Measures

First occurrence of HF-related healthcare resource utilization (HCRU) [up to 30 days]
First occurrence of post-discharge HF-related HCRU: hospitalization, emergency department [ED) visits, death or cardiac transplantation/ ventricular assist device [VAD] implant (composite)

Secondary Outcome Measures

First occurrence of HF-related hospitalization [up to 30 days]
First occurrence of post-discharge HF-related hospitalization
First occurrence of HF-related ED visit [up to 30 days]
First occurrence of post-discharge HF-related ED visit
First occurrence of post-discharge HF-related death or cardiac transplantation /ventricular assist device placement [up to 30 days]
First occurrence of post-discharge HF-related death or cardiac transplant/VAD
First occurrence of HF-related hospitalization [up to 180 days]
First occurrence of post-discharge HF-related hospitalization
First occurrence of HF-related ED visit [up to 180 days]
First occurrence of post-discharge HF-related ED visit
First occurrence of HF-related death or cardiac transplant/VAD [up to 180 days]
First occurrence of post-discharge HF-related death or cardiac transplant/VAD
First occurrence of all-cause healthcare resource utilization (HCRU) [up to 30 days]
First occurrence of post-discharge all-cause HCRU (composite)
First occurrence of all-cause healthcare resource utilization (HCRU) [up to 180 days]
First occurrence of post-discharge all-cause HCRU (composite)
First occurrence of all-cause hospitalization [up to 180 days]
First occurrence of post-discharge HF-related hospitalization
First occurrence of all-cause ED visit [up to 180 days]
First occurrence of post-discharge HF-related ED visit
First occurrence of all-cause death or cardiac transplant/VAD [up to 180 days]
First occurrence of post-discharge HF-related death or cardiac transplant/VAD
Total all-cause healthcare resource utilization (HCRU) [up to 180 days]
Total post-discharge all-cause HCRU (composite)
Total HF-related healthcare resource utilization (HCRU) [up to 180 days]
Total post-discharge HF-related HCRU (composite)
Time to first occurrence of HF-related healthcare resource utilization (HCRU) [up to 180 days]
First occurrence of post-discharge HF-related HCRU (composite)
Time to first occurrence of HF-related hospitalization [up to 180 days]
First occurrence of post-discharge HF-related hospitalization
Time to first occurrence of HF-related ED visit [up to 180 days]
First occurrence of post-discharge HF-related ED visit
Time to first occurrence of HF-related death or cardiac transplantation/VAD [up to 180 days]
First occurrence of post-discharge HF-related death or cardiac transplantation/VAD
Time to first occurrence of all-cause healthcare resource utilization (HCRU) [up to 180 days]
First occurrence of post-discharge all-cause HCRU (composite)
Time to first occurrence of all-cause hospitalization [up to 180 days]
First occurrence of post-discharge HF-related hospitalization
Time to first occurrence of all-cause ED visit [180 days]
First occurrence of post-discharge HF-related ED visit
Time to first occurrence of all-cause death or cardiac transplantation/VAD [up to 180 days]
First occurrence of post-discharge HF-related death or cardiac transplantation/VAD
Change in Functional status from baseline [up to 180 ays]
Change in Duke Activity Status Index (DASI) score from baseline
Change in dyspnea from baseline [up to 180 ays]
Change in PROMIS® Dyspnea Functional Limitations - Short Form 10a from baseline
Change in fatigue from baseline [up to 180 ays]
Change in a 10-item Fatigue Assessment Scale from baseline
Change in self-efficacy for managing symptoms, from baseline [up to 180 ays]
Change in PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline
Among intervention patients, HCRU based on all video views [30 days]
Among intervention patients, differences in HCRU based on number of video views
Among intervention patients, HCRU based on video views with family in hospital [30 days]
Among intervention patients, differences in HCRU based on video viewing with family (Y/N) in hospital
Among intervention patients, HCRU based on video views with family post hospital discharge [30 days]
Among intervention patients, differences in HCRU based on video viewing with family (Y/N) post hospital discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Center Navicent Health	Macon	Georgia	United States	31201
2	Cleveland Clinic Fairview Hospital	Cleveland	Ohio	United States	44111
3	Cleveland Clinic main campus	Cleveland	Ohio	United States	44195
4	Cleveland Clinic Marymount Hospital	Garfield Heights	Ohio	United States	44125
5	Cleveland Clinic Hillcrest Hospital	Mayfield Heights	Ohio	United States	44124
6	Cleveland Clinic Medina Hospital	Medina	Ohio	United States	44256
7	Cleveland Clinic South Pointe Hospital	Warrensville Heights	Ohio	United States	44122
8	WellSpan Health	York	Pennsylvania	United States	15198

Sponsors and Collaborators

The Cleveland Clinic
Wellflix, Inc.

Investigators

Principal Investigator: NANCY M. ALBERT, PhD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nancy M. Albert, Ph.D., Assocaite Chief Nursing Officer-Resaerch and Senior Nurse Scientist, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT03657459

Other Study ID Numbers:

18-442

First Posted:

Sep 5, 2018

Last Update Posted:

Aug 12, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nancy M. Albert, Ph.D., Assocaite Chief Nursing Officer-Resaerch and Senior Nurse Scientist, The Cleveland Clinic

video education

self care management

symptom recognition

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Aug 12, 2022