My Recordable On-Demand Audio Discharge Instructions

NCT02901314 | Completed Results

• 1 other identifier: 16-122
• Study Type: interventional
• Target: 2,487
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

• Number of Patients Rehospitalized With Heart Failure

  Number of patients re-hospitalized with heart failure.

  30 day

Secondary Outcomes (15)

• Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge

  Discharge from hospital

• Quality of Life (Health Status)

  Baseline

• Quality of Life (Health Status)

  45 day

• Symptoms

  Baseline

• Symptoms

  45 days

Study Arms (2)

MyRoad

EXPERIMENTAL

Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.

Other: on-demand audio messages of heart failure education themes

Usual care

NO INTERVENTION

Receives usual care heart failure education before discharge

Interventions

on-demand audio messages of heart failure education themes OTHER

MyRoad

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• American Greetings: collaborator

Study Sites (4)

Cleveland Clinic main campus

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Location

Cleveland Clinic Hillcrest hospital

Mayfield Heights, Ohio, 44124, United States

Location

Cleveland Clinic Medina Hospital

Medina, Ohio, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Nancy M. Albert, PhD, CCNS, CCHFN, CCRN, NE-BC, FAHA, FCCM, FHFSA, FAAN
• Organization: Cleveland Clinic

albertn@ccf.org

216-444-7028

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Nursing officer, Nursing Research and Innovation

Model Details: usual care education versus education with a pre-recorded card with heart failure instructions

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 15, 2016
• Study Start: March 1, 2016
• Primary Completion: September 30, 2020
• Study Completion: March 30, 2022
• Last Updated: May 7, 2025
• Results First Posted: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)