Heart Failure, CongestiveMyROADNCT02901314
My Recordable On-Demand Audio Discharge Instructions
A study testing on-demand audio messages of heart failure education themes in people with Heart Failure, Congestive, run by The Cleveland Clinic at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- on-demand audio messages of heart failure education themes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,487 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2016to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic main campus
Cleveland, Ohio, 44195
Cleveland Clinic Fairview Hospital
Cleveland, Ohio
Cleveland Clinic Hillcrest hospital
Mayfield Heights, Ohio, 44124
Cleveland Clinic Medina Hospital
Medina, Ohio
About this study
Official title: My Recordable On-Demand Audio Discharge Instructions (MyROAD)
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.
Read the 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 heart failure. 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 heart failure 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 heart failure, patients receive a heart failure handbook and a "zones" 1-page handout before discharge. In addition, they can watch multiple video clips of many heart failure topics and discuss heart failure 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 heart failure 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 purpose 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, emergency department visits and death/ cardiac transplantation/ventricular assist device, (3) 45-day quality of life (Kansas City Cardiomyopathy Questionnaire), symptoms (investigator initiated tool; used in previous research), functional status (Duke Activity Status Index) 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 heart failure will be randomized to either usual care or usual care and receiving a MyROAD card at discharge.
- Conditions
- Heart Failure, Congestive
- Being tested
- on-demand audio messages of heart failure education themes
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on-demand audio messages of heart failure education themesOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: on-demand audio messages of heart failure education themes |
| Usual care | No intervention | Receives usual care heart failure education before discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Rehospitalized With Heart Failure
Number of patients re-hospitalized with heart failure.
Measured: 30 day
Secondary outcomes (15)
Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge
Adherence to 7-day follow-up appointment with a healthcare provider; by medical record chart review
Measured: Discharge from hospital
Quality of Life (Health Status)
Quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire that measures physical limitations, symptoms, self-efficacy, social interference and quality of life. The KCCQ is a standardized score from 0 to 100 points. A score of 0 is the lowest quality of life (poor) and score of 100 is the highest quality of life.
Measured: Baseline
Quality of Life (Health Status)
Quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire that measures physical limitations, symptoms, self-efficacy, social interference and quality of life. The KCCQ is a standardized score from 0 to 100 points. A score of 0 is the lowest quality of life (poor) and score of 100 is the highest quality of life.
Measured: 45 day
Symptoms
29-item list of heart failure-related symptoms. Patients were asked to consider any symptoms they experienced in the last 2 weeks and choose all that apply. Patients could also check "do not weigh self" and "no signs or symptoms of anything abnormal". The median [Q1, Q3] number of symptoms was reported between groups.
Measured: Baseline
Symptoms
29-item list of heart failure-related symptoms. Patients were asked to consider any symptoms they experienced in the last 2 weeks and choose all that apply. Patients could also check "do not weigh self" and "no signs or symptoms of anything abnormal". The median [Q1, Q3] number of symptoms was reported between groups.
Measured: 45 days
Functional Status
Duke Activity Status Index (DASI) is a 12-item questionnaire using Likert scale that determines a patient's ability to participate in common, everyday activities without difficulty including self-care activities (e.g., ambulation, housework, yard work, sexual relations, and recreational activities. This is a patient-reported tool that measures functional status in patients with heart failure.
Scores range from 0 (no functional capacity = worst score) to 58.2 (highest functional capacity = best score).
Measured: Baseline
Functional Status
Duke Activity Status Index (DASI) is a 12-item questionnaire. This is a patient-reported tool that measures functional status in patients with heart failure. Patients were called by telephone and asked to rate their ability to do daily activities (e.g., personal care, ambulation, household tasks, sexual function, and recreation).
Scores range from 0 (no functional capacity = worst score) to 58.2 (highest functional capacity = best score).
Measured: 45 day
Adherence to Activity Recommendations
Modified PACE tool; used in previous research. Patients were asked to self-report their perceived adherence to activity recommendations by selecting the option on a checklist that matched their activity level.
Measured: Baseline
Adherence to Activity Recommendations
Modified PACE tool; used in previous research. Patient's were contacted by telephone and asked to self-report their perceived adherence to activity recommendations.
Measured: 45 day
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
All-cause re-hospitalization, death, left ventricular assist device (LVAD), or cardiac transplant via medical record chart review; interview (telephone call).
Measured: 90 days
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
All-cause re-hospitalization, death, left ventricular assist device (LVAD), or cardiac transplant via medical record chart review; interview (telephone call).
Measured: 180 days
Number of Patients Rehospitalized With Heart Failure
Number of patients rehospitalized with heart failure via chart review; interview (telephone call).
Measured: 45 days
Number of Patients Rehospitalized With Heart Failure
Number of patients rehospitalized with heart failure via chart review
Measured: 90 days
Number of Patients Rehospitalized With Heart Failure
Number of patients rehospitalized with heart failure via chart review; interview (telephone call).
Measured: 180 days
Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit
Number of patients with all-cause rehospitalization, death, or emergency department visits within 180 days. Information is obtained via medical record chart review.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start1 Mar 2016
- Primary completion30 Sep 2020
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- usual care education versus education with a pre-recorded card with heart failure instructions
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,487 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Greetings
- Responsible party
- Principal investigator, Nancy M. Albert, Ph.D., The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901314
- Sponsor's protocol ID
- 16-122
- Acronym
- MyROAD
- Status last verified
- Apr 2025
- First submitted
- 1 Sep 2016
- Last updated
- 7 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Recordable On-Demand Audio Discharge Instructions (MyROAD)
- ClinicalTrials.gov ID
- NCT02901314
- Acronym / sponsor ID
- MyROAD / 16-122
- Conditions
- Heart Failure, Congestive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,487 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- American Greetings
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Posted 7 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 heart failure. 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 heart failure 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 heart failure, patients receive a heart failure handbook and a "zones" 1-page handout before discharge. In addition, they can watch multiple video clips of many heart failure topics and discuss heart failure 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 heart failure 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 purpose 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, emergency department visits and death/ cardiac transplantation/ventricular assist device, (3) 45-day quality of life (Kansas City Cardiomyopathy Questionnaire), symptoms (investigator initiated tool; used in previous research), functional status (Duke Activity Status Index) 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 heart failure will be randomized to either usual care or usual care and receiving a MyROAD card at discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- usual care education versus education with a pre-recorded card with heart failure instructions
| Arm | Type | Receives |
|---|---|---|
| MyRoad | Experimental | Other: on-demand audio messages of heart failure education themesReceives 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. |
| Usual care | No intervention | –Receives usual care heart failure education before discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| on-demand audio messages of heart failure education themes | Other | MyRoad |
Primary outcome
Number of Patients Rehospitalized With Heart Failure
Time frame: 30 day
Number of patients re-hospitalized with heart failure.
15 secondary outcomes
Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge
Time frame: Discharge from hospital
Quality of Life (Health Status)
Time frame: Baseline
Quality of Life (Health Status)
Time frame: 45 day
Symptoms
Time frame: Baseline
Symptoms
Time frame: 45 days
Functional Status
Time frame: Baseline
Functional Status
Time frame: 45 day
Adherence to Activity Recommendations
Time frame: Baseline
Adherence to Activity Recommendations
Time frame: 45 day
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
Time frame: 90 days
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
Time frame: 180 days
Number of Patients Rehospitalized With Heart Failure
Time frame: 45 days
Number of Patients Rehospitalized With Heart Failure
Time frame: 90 days
Number of Patients Rehospitalized With Heart Failure
Time frame: 180 days
Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing on-demand audio messages of heart failure education themes in people with Heart Failure, Congestive, run by The Cleveland Clinic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Rehospitalized With Heart Failure (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.