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My Recordable On-Demand Audio Discharge Instructions (MyROAD)

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
on-demand audio messages of heart failure education themes
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure, Congestive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 HF 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 HF (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.

Sites / Locations

  • Cleveland Clinic main campus
  • Cleveland Clinic Fairview Hospital
  • Cleveland Clinic Hillcrest hospital
  • Cleveland Clinic Medina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MyRoad

Usual care

Arm Description

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.

Receives usual care heart failure education before discharge

Outcomes

Primary Outcome Measures

heart failure rehospitalization
Chart review; interviews

Secondary Outcome Measures

time to first occurrence of HF-related hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device(composite outcome)
chart review; interviews
functional status
Duke Activity Status Index (telephone call)
perceived adherence to activity recommendations
investigator developed tool; used in previous research (telephone call)
7-day follow-up appointment with the healthcare provider assigned before discharge
chart review; interview (telephone call)
all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome)
chart review; interview (telephone call)
all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome)
chart review; interview (telephone call)
all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome)
chart review; interview (telephone call)
quality of life (health status)
Kansas City Cardiomyopathy Questionnaire; telephone call
Symptoms of HF
investigator developed tool; used in previous research; telephone call
time to first occurrence of all-cause hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device (composite outcome)
chart review; interview (telephone call)
heart failure re-hospitalization
chart review; interview (telephone call)
heart failure re-hospitalization
chart review; interview (telephone call)
time to first occurrence of all-cause hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device (composite outcome)
chart review; interview (telephone call)

Full Information

First Posted
September 1, 2016
Last Updated
August 11, 2022
Sponsor
The Cleveland Clinic
Collaborators
American Greetings
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1. Study Identification

Unique Protocol Identification Number
NCT02901314
Brief Title
My Recordable On-Demand Audio Discharge Instructions
Acronym
MyROAD
Official Title
My Recordable On-Demand Audio Discharge Instructions (MyROAD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
American Greetings

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Most patients are discharged with a complex set of instructions that include multiple medications (and differing mediation administration plans), sodium restricted diet, fluid management actions (daily weight monitoring and in some cases, fluid restriction), monitoring signs and symptoms of HF, activity and exercise, and when to return for follow-up. At discharge, patients (and their families) may not understand that HF is chronic. Improvement in quality of life may be dependent on patients' acceptance of HF as a chronic, irreversible condition that requires self-care monitoring and behaviors (for example, becoming or staying physically active), even when they feel fine. To decrease the complexity of understanding HF, patients receive a HF handbook and a "zones" 1-page handout before discharge. In addition, they can watch multiple video clips of many HF topics and discuss HF self-care with the hospital healthcare team. However, patients may not read (or view) education materials due to health literacy issues, cognitive decline, eyesight issues, fatigue or depression. Patients may rely on lay (family) caregivers to understand self-car expectations and be active partners in care. Caregivers engaged in patients' care may not be present at discharge or may have preconceived or inaccurate ideas about HF self-care after discharge. A recorded message that could be repeatedly played by patients and caregivers might increase adherence to post-discharge self-care behaviors and 7-day 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 (1) 45-, 90-, and 180-day first occurrence and (2) time to first occurrence of all-cause and HF-related hospitalization, ED visits and death/ cardiac transplantation/ventricular assist device, (3) 45-day quality of life (KCCQ), symptoms (investigator initiated tool; used in previous research), functional status (DASI) and perceived adherence to activity recommendations (investigator initiated tool; used in previous research), and (4) 7-day follow-up appointment with the healthcare provider assigned before discharge. A total of 1066 patients (968 + 10% attrition) with decompensated HF will be randomized to either usual care or usual care and receiving a MyROAD card at discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
usual care education versus education with a pre-recorded card with heart failure instructions
Masking
Investigator
Allocation
Randomized
Enrollment
1073 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MyRoad
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Receives usual care heart failure education before discharge
Intervention Type
Other
Intervention Name(s)
on-demand audio messages of heart failure education themes
Primary Outcome Measure Information:
Title
heart failure rehospitalization
Description
Chart review; interviews
Time Frame
30 day
Secondary Outcome Measure Information:
Title
time to first occurrence of HF-related hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device(composite outcome)
Description
chart review; interviews
Time Frame
time to first occurrence up to 30 days
Title
functional status
Description
Duke Activity Status Index (telephone call)
Time Frame
45 day
Title
perceived adherence to activity recommendations
Description
investigator developed tool; used in previous research (telephone call)
Time Frame
45 day
Title
7-day follow-up appointment with the healthcare provider assigned before discharge
Description
chart review; interview (telephone call)
Time Frame
45 day
Title
all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome)
Description
chart review; interview (telephone call)
Time Frame
180 days
Title
all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome)
Description
chart review; interview (telephone call)
Time Frame
30 days
Title
all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome)
Description
chart review; interview (telephone call)
Time Frame
90 day
Title
quality of life (health status)
Description
Kansas City Cardiomyopathy Questionnaire; telephone call
Time Frame
45 day
Title
Symptoms of HF
Description
investigator developed tool; used in previous research; telephone call
Time Frame
45 day
Title
time to first occurrence of all-cause hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device (composite outcome)
Description
chart review; interview (telephone call)
Time Frame
time to first occurrence up to 180 days
Title
heart failure re-hospitalization
Description
chart review; interview (telephone call)
Time Frame
180 day
Title
heart failure re-hospitalization
Description
chart review; interview (telephone call)
Time Frame
90 day
Title
time to first occurrence of all-cause hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device (composite outcome)
Description
chart review; interview (telephone call)
Time Frame
time to first occurrence up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 HF 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 HF (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.
Facility Information:
Facility Name
Cleveland Clinic main campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleveland Clinic Fairview Hospital
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Cleveland Clinic Hillcrest hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Cleveland Clinic Medina Hospital
City
Medina
State/Province
Ohio
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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