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N/A N=1,073 Randomized Single-blind Supportive Care

My Recordable On-Demand Audio Discharge Instructions

Heart Failure, Congestive

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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