N/A
Completed N=1,073
My Recordable On-Demand Audio Discharge Instructions
Heart Failure, Congestive
Source: ClinicalTrials.gov NCT02901314 ↗
Enrolled (actual)
1,073
Serious AEs
—
Results posted
May 2025
Primary outcomePrimary: Number of Patients Rehospitalized With Heart Failure — 71; 78; 425; 397 Participants
Summary
Non-adherence to the heart failure (HF) plan of care after hospital discharge has been associated with clinical outcomes, including the combined endpoint of all-cause mortality and rehospitalization for decompensated HF. Patients and informal caregivers receive education materials but may not act due to multiple factors. A recorded message that could be repeatedly played by patients and caregivers might increase adherence to post-discharge self-care behaviors and early follow-up appointments, and have clinical benefits related to a reduction in all-cause mortality and rehospitalization. The purposes of this randomized, controlled study are to examine the effects of use of a novel MyROAD (Recordable On-Demand Audio Discharge) card, given to patients at discharge. The aims of this single-blind, placebo-controlled study are to examine the effects of recorded messages that can be replayed post discharge (delivered via the MyROAD card) on multiple subjective and objective clinical outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Rehospitalized With Heart Failure |
192; 183 | — |
| SECONDARY Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge |
290; 285 | — |
| SECONDARY Quality of Life (Health Status) |
62.6; 64.5 | — |
| SECONDARY Symptoms |
4.0; 4.0 | — |
| SECONDARY Functional Status |
18.1; 18.3 | — |
| SECONDARY Adherence to Activity Recommendations |
186; 161; 162; 148; 8; 7 | — |
| SECONDARY Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome) |
331; 322 | — |
| SECONDARY Number of Patients Rehospitalized With Heart Failure |
192; 183 | — |
| SECONDARY Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit |
331; 322 | — |
Eligibility Criteria
Inclusion Criteria
- Not referred for cardiac transplantation or ventricular assist device during the index hospitalization,
- Minimum age 18 years (no upper age limit),
- Ability to read and write,
- Discharge to home or to a family member's home and has control of making self-care decisions,
- Willing to participate; which requires three (3) follow-up telephone calls post-discharge.
Exclusion Criteria
- Chart documented psychiatric or cognitive conditions that limit ability to understand or adhere to self-care recommendations (Alzheimer's condition, dementia, schizophrenia, other neurological history that impairs memory),
- Plans to discharge to assisted living apartment/center, skilled nursing facility or hospice care center,
- 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 heart failure),
- Post-cardiac transplantation or ventricular assist device placement,
- Currently enrolled in another experimental heart failure research study,
- Chronic renal failure and receiving chronic hemodialysis therapy for an estimated glomerular filtration rate < 30 mL/minute/1.73 m2,
- A non-traditional form of heart failure (hypertrophic or restrictive forms of cardiomyopathy, congenital heart disease or Takotsubo cardiomyopathy).
- Wheelchair bound, uses a cane or walker, or unable to carry out physical activity, including walking,due to a chronic disability or documented medical condition.
Data sourced from ClinicalTrials.gov (NCT02901314). 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. Informational only — not medical advice.