Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Heart failure is a long-term health problem that can cause shortness of breath, fatigue, and rapid heartbeat. Patients with heart failure often go to their healthcare providers, such as doctors and nurses, or the emergency room to manage their symptoms.
In this study, the research team is looking to see how well a telehealth support program called I-COACH helps patients manage heart failure compared with enhanced usual care. Telehealth helps with providing care to patients remotely using phone, video, or monitoring devices.
Who can this research help?
Results may help providers, patients, and caregivers when considering ways to manage heart failure.
What is the research team doing?
The research team is assigning 400 patient-caregiver pairs by chance to take part in the I-COACH program or receive enhanced usual care.
The I-COACH program helps patients remotely monitor their blood pressure, heart rate, weight, pulse, and oxygen levels. It also lets providers see patients’ health data in real time. I-COACH sends automatic patient updates to a call center. If results are higher or lower than normal, a nurse at the call center checks with the patient and contacts the patient’s provider if needed. Patients communicate with their providers through I-COACH video appointments and messaging.
Patients and caregivers receiving enhanced usual care attend their regular appointments in person or by phone as needed. These patients are also receiving home equipment and a logbook to record vital signs and monitor weight, blood pressure, and pulse.
Patients and caregivers complete a survey at the start of the study and again three and six months later. The patient survey asks about self-care for heart failure and other outcomes such as depression, pain, and physical function. The caregiver survey asks about caregiver burden, health, and satisfaction with care.
Patients with heart failure, caregivers, and healthcare professionals are helping to plan and conduct this study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 400 patients ages 55 and older with heart failure and their caregivers |
| Interventions/ Comparators |
|
| Outcomes |
Primary: self-care for heart failure Secondary: patient-reported anxiety, depression, fatigue, pain interference, pain intensity, physical function, sleep disturbance, ability to participate in social roles and activities, health distress, and quality of life; caregiver burden and health; health system outcomes including patient satisfaction with care received, number of medical treatment visits, and mortality |
| 6-month follow-up for primary outcome |
COVID-19-Related Study
Summary
This study received additional funding in 2020 to quickly initiate new research related to COVID-19. The additional research is in progress. PCORI will post the research findings on this page once the results are final.
To reduce the risk of spreading the virus that causes COVID-19, many health systems have shifted from in-person to telehealth care. Telehealth provides care to patients remotely using phone, video, or other devices that can help manage care.
With this enhancement, the research team wants to learn how telehealth affects care for patients with heart failure. The team will compare in-person versus telehealth healthcare provider visits. They will look at:
- Quality of care, communication, and patient satisfaction
- Data about the visits, such as average wait time; missed, rescheduled, or delayed visits; and number of patients seen per day
- Patient use of health care that is related to the type of visit, such as number of provider, hospital, or emergency visits and diagnostic testing
This study will help decide which type of medical visit results in highest quality care and will identify gaps between actual practice and needs of older adults with heart failure during this pandemic.
Enhancement Award Amount: $499,701