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Danger Signs in Heart Failure- Effects of Video Education

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ClinicalTrials.gov Identifier: NCT03657459
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Wellflix, Inc.
Information provided by (Responsible Party):
Nancy M. Albert, Ph.D., The Cleveland Clinic

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, 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 : July 26, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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)




Primary Outcome Measures :
  1. First occurrence of HF-related healthcare resource utilization (HCRU) [ Time Frame: 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 :
  1. First occurrence of HF-related hospitalization [ Time Frame: up to 30 days ]
    First occurrence of post-discharge HF-related hospitalization

  2. First occurrence of HF-related ED visit [ Time Frame: up to 30 days ]
    First occurrence of post-discharge HF-related ED visit

  3. First occurrence of post-discharge HF-related death or cardiac transplantation /ventricular assist device placement [ Time Frame: up to 30 days ]
    First occurrence of post-discharge HF-related death or cardiac transplant/VAD

  4. First occurrence of HF-related hospitalization [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related hospitalization

  5. First occurrence of HF-related ED visit [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related ED visit

  6. First occurrence of HF-related death or cardiac transplant/VAD [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related death or cardiac transplant/VAD

  7. First occurrence of all-cause healthcare resource utilization (HCRU) [ Time Frame: up to 30 days ]
    First occurrence of post-discharge all-cause HCRU (composite)

  8. First occurrence of all-cause healthcare resource utilization (HCRU) [ Time Frame: up to 180 days ]
    First occurrence of post-discharge all-cause HCRU (composite)

  9. First occurrence of all-cause hospitalization [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related hospitalization

  10. First occurrence of all-cause ED visit [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related ED visit

  11. First occurrence of all-cause death or cardiac transplant/VAD [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related death or cardiac transplant/VAD

  12. Total all-cause healthcare resource utilization (HCRU) [ Time Frame: up to 180 days ]
    Total post-discharge all-cause HCRU (composite)

  13. Total HF-related healthcare resource utilization (HCRU) [ Time Frame: up to 180 days ]
    Total post-discharge HF-related HCRU (composite)

  14. Time to first occurrence of HF-related healthcare resource utilization (HCRU) [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related HCRU (composite)

  15. Time to first occurrence of HF-related hospitalization [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related hospitalization

  16. Time to first occurrence of HF-related ED visit [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related ED visit

  17. Time to first occurrence of HF-related death or cardiac transplantation/VAD [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related death or cardiac transplantation/VAD

  18. Time to first occurrence of all-cause healthcare resource utilization (HCRU) [ Time Frame: up to 180 days ]
    First occurrence of post-discharge all-cause HCRU (composite)

  19. Time to first occurrence of all-cause hospitalization [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related hospitalization

  20. Time to first occurrence of all-cause ED visit [ Time Frame: 180 days ]
    First occurrence of post-discharge HF-related ED visit

  21. Time to first occurrence of all-cause death or cardiac transplantation/VAD [ Time Frame: up to 180 days ]
    First occurrence of post-discharge HF-related death or cardiac transplantation/VAD

  22. Change in Functional status from baseline [ Time Frame: up to 180 ays ]
    Change in Duke Activity Status Index (DASI) score from baseline

  23. Change in dyspnea from baseline [ Time Frame: up to 180 ays ]
    Change in PROMIS® Dyspnea Functional Limitations - Short Form 10a from baseline

  24. Change in fatigue from baseline [ Time Frame: up to 180 ays ]
    Change in a 10-item Fatigue Assessment Scale from baseline

  25. Change in self-efficacy for managing symptoms, from baseline [ Time Frame: up to 180 ays ]
    Change in PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline

  26. Among intervention patients, HCRU based on all video views [ Time Frame: 30 days ]
    Among intervention patients, differences in HCRU based on number of video views

  27. Among intervention patients, HCRU based on video views with family in hospital [ Time Frame: 30 days ]
    Among intervention patients, differences in HCRU based on video viewing with family (Y/N) in hospital

  28. Among intervention patients, HCRU based on video views with family post hospital discharge [ Time Frame: 30 days ]
    Among intervention patients, differences in HCRU based on video viewing with family (Y/N) post hospital discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

Please answer each question as it applies to you.

Sex: 0.______ Male 1.______ Female

Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657459


Contacts
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Contact: NANCY M. ALBERT, PhD 2164447028 ext 2164447028 albertn@ccf.org

Locations
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United States, Georgia
Medical Center Navicent Health Active, not recruiting
Macon, Georgia, United States, 31201
United States, Ohio
Cleveland Clinic Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: NANCY M ALBERT, PhD    216-444-7028 ext 2164447028    albertn@ccf.org   
Cleveland Clinic main campus Recruiting
Cleveland, Ohio, United States, 44195
Contact: NANCY M ALBERT, PhD    216-444-7028    albertn@ccf.org   
Cleveland Clinic Marymount Hospital Recruiting
Garfield Heights, Ohio, United States, 44125
Contact: Nancy M Albert, PhD    216-444-7028    albertn@ccf.org   
Cleveland Clinic Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: NANCY M ALBERT    216-444-7028 ext 2164447028    albertn@ccf.org   
Cleveland Clinic Medina Hospital Recruiting
Medina, Ohio, United States, 44256
Contact: Nancy M Albert, PhD    216-444-7028    albertn@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Wellflix, Inc.
Investigators
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Principal Investigator: NANCY M. ALBERT, PhD The Cleveland Clinic

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Responsible Party: Nancy M. Albert, Ph.D., Assocaite Chief Nursing Officer-Resaerch and Senior Nurse Scientist, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03657459     History of Changes
Other Study ID Numbers: 18-442
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share individual data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nancy M. Albert, Ph.D., The Cleveland Clinic:
video education
self care management
symptom recognition
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases