N/A
N=746
Danger Signs in Heart Failure- Effects of Video Education
Heart Failure; With Decompensation
Bottom Line
View on ClinicalTrials.gov: NCT03657459 ↗Enrolled (actual)
746
Serious AEs
63.5%
Results posted
May 2025
Primary outcome: Primary: Number of Participants With HF-related Healthcare Resource Utilization (HCRU) — 64; 59 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Danger Signs of Heart Failure Videos (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With HF-related Healthcare Resource Utilization (HCRU) |
111; 135 | — |
| SECONDARY Number of Participants With HF-related Hospitalization |
104; 128 | — |
| SECONDARY Number of Participants With HF-related ED Visits |
40; 36 | — |
| SECONDARY Number of Participants With HF-related Death |
15; 14 | — |
| SECONDARY Number of Participants With HF-related Healthcare Resource Utilization (HCRU) |
111; 135 | — |
| SECONDARY Number of Participants With HF-related Hospitalization |
104; 128 | — |
| SECONDARY Number of Participants With HF-related ED Visit |
73; 91 | — |
| SECONDARY Number of Participants With HF-related Death |
15; 14 | — |
| SECONDARY Number of Participants With HF-related Healthcare Resource Utilization (HCRU) |
111; 135 | — |
| SECONDARY Number of Participants With HF-related Hospitalization |
104; 128 | — |
| SECONDARY Number of Participants With HF-related ED Visit |
73; 91 | — |
| SECONDARY Number of Participants With HF-related Death |
15; 14 | — |
| SECONDARY Number of Participants With All-cause Healthcare Resource Utilization (HCRU) |
232; 242 | — |
| SECONDARY Number of Participants With All-cause Hospitalization |
195; 188 | — |
| SECONDARY Number of Participants With All-cause ED Visits |
132; 134 | — |
| SECONDARY Number of Participants With All-cause Death |
30; 22 | — |
| SECONDARY Number of Participants With All-cause Healthcare Resource Utilization (HCRU) |
232; 242 | — |
| SECONDARY Number of Participants With All-cause Hospitalization |
195; 188 | — |
| SECONDARY Number of Participants With All-cause ED Visits |
132; 134 | — |
| SECONDARY Number of Participants With All-cause Death |
30; 22 | — |
| SECONDARY Number of Participants With All-cause Healthcare Resource Utilization (HCRU) |
232; 242 | — |
| SECONDARY Number of Participants With All-cause Hospitalization |
195; 188 | — |
| SECONDARY All-cause ED Visits at 180 Days |
160; 179 | 0.0096 sig |
| SECONDARY All-cause Death at 180 Days Post Discharge |
42; 40 | 0.90 |
| SECONDARY Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge |
17.2; 18.2 | — |
| SECONDARY Dyspnea at 30 Days Post Discharge |
46.1; 45.8 | — |
| SECONDARY Fatigue at 30 Days Post Discharge |
23.8; 23.3 | — |
| SECONDARY Self-efficacy for Managing Symptoms at 30 Days Post Discharge |
42.9; 43.4 | — |
| SECONDARY Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+) |
76; 25 | — |
| SECONDARY Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no) |
94; 7 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT03657459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.