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Completed

NCT Number: NCT03657459

Danger Signs in Heart Failure- Effects of Video Education

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center Navicent Health, Macon, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

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

    Time frame: up to 30 days

    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.

Secondary outcomes

  1. Number of Participants With HF-related Hospitalization

    Time frame: up to 30 days

    Total number of participants post-discharge with HF-related hospitalization

  2. Number of Participants With HF-related ED Visits

    Time frame: up to 30 days

    Number of participants with post-discharge HF-related ED visits

  3. Number of Participants With HF-related Death

    Time frame: up to 30 days

    Number of participants post-discharge with HF-related death

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

    Time frame: up to 90 days

    Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.

  5. Number of Participants With HF-related Hospitalization

    Time frame: up to 90 days

    Number of participants post-discharge with HF-related hospitalization

  6. Number of Participants With HF-related ED Visit

    Time frame: up to 90 days

    Number of participants post-discharge with HF-related ED visit

  7. Number of Participants With HF-related Death

    Time frame: up to 90 days

    Number of participants post-discharge with HF-related death

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

    Time frame: up to 180 days

    Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.

  9. Number of Participants With HF-related Hospitalization

    Time frame: up to 180 days

    Number of participants post-discharge with HF-related hospitalization

  10. Number of Participants With HF-related ED Visit

    Time frame: up to 180 days

    Number of participants post-discharge with HF-related ED visit

  11. Number of Participants With HF-related Death

    Time frame: up to 180 days

    Number of participants post-discharge with HF-related death

  12. Number of Participants With All-cause Healthcare Resource Utilization (HCRU)

    Time frame: up to 30 days

    Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.

  13. Number of Participants With All-cause Hospitalization

    Time frame: up to 30 days

    Number of participants post-discharge with all-cause hospitalization

  14. Number of Participants With All-cause ED Visits

    Time frame: 30 days

    Number of participants with post-discharge all-cause ED visits

  15. Number of Participants With All-cause Death

    Time frame: up to 30 days

    Number of participants post-discharge with all-cause deaths

  16. Number of Participants With All-cause Healthcare Resource Utilization (HCRU)

    Time frame: up to 90 days

    Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.

  17. Number of Participants With All-cause Hospitalization

    Time frame: up to 90 days

    Number of participants with post-discharge all-cause hospitalization

  18. Number of Participants With All-cause ED Visits

    Time frame: up to 90 days

    Number of participants post-discharge with all-cause ED visits

  19. Number of Participants With All-cause Death

    Time frame: up to 90 days

    Number of participants post-discharge with all-cause death

  20. Number of Participants With All-cause Healthcare Resource Utilization (HCRU)

    Time frame: up to 180 days

    Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.

  21. Number of Participants With All-cause Hospitalization

    Time frame: up to 180 days

    Number of participants post-discharge with all-cause hospitalization

  22. All-cause ED Visits at 180 Days

    Time frame: up to 180 days

    Number of participants post-discharge with all-cause ED visits

  23. All-cause Death at 180 Days Post Discharge

    Time frame: up to 180 days

    Number of participants post-discharge with all-cause death

  24. Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge

    Time frame: up to 30 days

    Duke Activity Status Index (DASI) score at 30 days. Patients completed the DASI, a 12-item questionnaire using a Likert-like scale that determines a patient's ability to participate in daily self-care activities including ambulation, housework, yard work, sexual relations, and recreational activities. A total score reflects functional status based on responses. The full range of scores is 0 (most severe functional impairment) to 58.2 (no functional impairment). There is no established cut-point for this scale. Positive, higher scores reflect a positive and better functional status.

  25. Dyspnea at 30 Days Post Discharge

    Time frame: 30 days

    PROMIS® Dyspnea Functional Limitations - Short Form 10a was used. It is a 10-item tool that measures dyspnea by asking 10 questions about the difficulty in completing activities in the past 7 days. Responses range from "0 = no difficulty" to "3 = much difficulty" and there is an option for "I did not do this in the past 7 days" - there were 5 response options in total. Minimum and maximum raw scores are 0-30. PROMIS T scores are standardized with scores around 50 (standard deviation of 10) equating to normal/average levels and scores above or below equating to heightening or lessening of the variable being measured. A 5 point change in score is considered significant. A table is used to translate the total raw score to T score for each participant.

  26. Fatigue at 30 Days Post Discharge

    Time frame: to 30 days

    10-item Fatigue Assessment Scale from baseline. The Fatigue Assessment Scale is a valid, reliable 10-item scale evaluating symptoms of chronic fatigue. It uses Likert-type response options ranging from 1 ("never") to 5 ("always"), with some items reverse scored. Total scores range from 10 (lowest level of fatigue) to 50 (highest level of fatigue).

  27. Self-efficacy for Managing Symptoms at 30 Days Post Discharge

    Time frame: 30 days

    PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline. 8-item tool that ranges from 'I am not at all confident' to 'I am very confident" - higher scores equals higher self-efficacy. A mean score of 50 is the average score in the general population of U.S. with standard deviation of 10. A table is used to translate the total raw score to T score for each participant. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores (above 50) reflect better than average self-efficacy

  28. Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)

    Time frame: 30 days

    Among intervention group participants, total number of all-cause events within 30 days of discharge, based on the number of times the patient watched the video education. Participant responses are grouped into two categories: Never watched vs. 1 or more times

  29. Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no)

    Time frame: 30 days

    Total number of participants (video education group only), comparison of all-cause events within 30 days of discharge, based on family members watching the educational videos after the hospital (Yes/No).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Wellflix, Inc.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 5, 2018
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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