Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02901314 |
| Other study ID # |
16-122 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2016 |
| Est. completion date |
March 30, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
The Cleveland Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
