N/A
N=1,073
My Recordable On-Demand Audio Discharge Instructions
Heart Failure, Congestive
Bottom Line
View on ClinicalTrials.gov: NCT02901314 ↗Enrolled (actual)
1,073
Serious AEs
—
Results posted
May 2025
Primary outcome: Primary: Number of Patients Rehospitalized With Heart Failure — 71; 78; 425; 397 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- on-demand audio messages of heart failure education themes (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Sep 2020
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 Quality of Life (Health Status) |
62.6; 64.5 | — |
| SECONDARY Symptoms |
4.0; 4.0 | — |
| SECONDARY Symptoms |
4.0; 4.0 | — |
| SECONDARY Functional Status |
18.1; 18.3 | — |
| SECONDARY Functional Status |
18.1; 18.3 | — |
| SECONDARY Adherence to Activity Recommendations |
186; 161; 162; 148; 8; 7 | — |
| 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 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 Rehospitalized With Heart Failure |
192; 183 | — |
| 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 | — |
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.
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.