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My Recordable On-Demand Audio Discharge Instructions (MyROAD)

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ClinicalTrials.gov Identifier: NCT02901314
Recruitment Status : Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
American Greetings
Information provided by (Responsible Party):
Nancy M. Albert, Ph.D., The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Other: on-demand audio messages of heart failure education themes Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1066 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: usual care education versus education with a pre-recorded card with heart failure instructions
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: My Recordable On-Demand Audio Discharge Instructions (MyROAD)
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: MyRoad
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
No Intervention: Usual care
Receives usual care heart failure education before discharge



Primary Outcome Measures :
  1. heart failure rehospitalization [ Time Frame: 30 day ]
    Chart review; interviews


Secondary Outcome Measures :
  1. time to first occurrence of HF-related hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device(composite outcome) [ Time Frame: time to first occurrence up to 30 days ]
    chart review; interviews

  2. functional status [ Time Frame: 45 day ]
    Duke Activity Status Index (telephone call)

  3. perceived adherence to activity recommendations [ Time Frame: 45 day ]
    investigator developed tool; used in previous research (telephone call)

  4. 7-day follow-up appointment with the healthcare provider assigned before discharge [ Time Frame: 45 day ]
    chart review; interview (telephone call)

  5. all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome) [ Time Frame: 180 days ]
    chart review; interview (telephone call)

  6. all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome) [ Time Frame: 30 days ]
    chart review; interview (telephone call)

  7. all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome) [ Time Frame: 90 day ]
    chart review; interview (telephone call)

  8. quality of life (health status) [ Time Frame: 45 day ]
    Kansas City Cardiomyopathy Questionnaire; telephone call

  9. Symptoms of HF [ Time Frame: 45 day ]
    investigator developed tool; used in previous research; telephone call

  10. time to first occurrence of all-cause hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device (composite outcome) [ Time Frame: time to first occurrence up to 180 days ]
    chart review; interview (telephone call)

  11. heart failure re-hospitalization [ Time Frame: 180 day ]
    chart review; interview (telephone call)

  12. heart failure re-hospitalization [ Time Frame: 90 day ]
    chart review; interview (telephone call)

  13. time to first occurrence of all-cause hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device (composite outcome) [ Time Frame: time to first occurrence up to 90 days ]
    chart review; interview (telephone call)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901314


Locations
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United States, Ohio
Cleveland Clinic main campus
Cleveland, Ohio, United States, 44195
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Hillcrest hospital
Mayfield Heights, Ohio, United States, 44124
Sponsors and Collaborators
The Cleveland Clinic
American Greetings

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Responsible Party: Nancy M. Albert, Ph.D., Associate Chief Nursing officer, Nursing Research and Innovation, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02901314     History of Changes
Other Study ID Numbers: 16-122
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases