Heart Failure, Congestive Clinical Trial
Official title:
Mobilizing Peer Support for Effective Heart Failure Self-Management
Heart failure (HF) patients living in low-income or isolated areas may have limited access to necessary clinic services and more difficulty in self-managing their illness. This study will evaluate a program that combines group health care visits and a peer-to-peer telephone buddy system at improving health outcomes among low-income and racial minority HF patients.
HF is a life-threatening condition in which the heart can no longer pump enough blood to the
rest of the body. It is important for individuals with heart failure to closely monitor
their symptoms, seek out medical attention when appropriate, and effectively self-manage
their condition. However, people with HF are often frail, poor, and socially isolated. These
factors may limit their ability to access clinic-based services and self-manage their
condition. Research has shown that group health care visits with other HF patients and peer
support for self-care behaviors are effective at improving heath care outcomes. This study
will use an interactive voice response (IVR) system, which is a low-cost telephone system
that allows calls to be made through a central 1-800 number, thereby eliminating the need to
distribute home phone numbers or pay for long distance calls. Through the IVR system,
participants will receive and provide peer support by sharing and discussing HF
self-management techniques. The IVR system will also facilitate patient communication with
care managers. This study will evaluate the effectiveness of the peer-to-peer IVR program in
combination with group health care visits led by HF nurses at reducing hospitalization and
death rates among HF patients. Participants will be drawn from a community health care
system that primarily serves large numbers of racial minority and socioeconomically
vulnerable people.
This study will enroll 288 moderate- to high-risk HF patients from St. Joseph Mercy Health
System in Ypsilanti, Michigan. Participants will be paired up with another HF patient, based
on gender and illness severity. Each pair will be randomly assigned to receive either usual
care or usual care plus the nurse-led group visits and the IVR program. Participants using
IVR will receive training in peer communication techniques and participate in an initial
nurse-led interactive group visit. They will then be asked to communicate at least weekly
with their partner using the IVR system. The IVR system will also automatically send
reminder calls to participants and allow them to leave voice mail messages for their partner
and their care manager. At Months 1, 3, and 6, participants will take part in group visits
led by nurses to discuss HF self-management strategies. Study staff will monitor
participants' use of the IVR system, including the dates, duration, and recipients of all
phone calls. At Months 6 and 12, all participants will complete questionnaires and undergo a
medical record review to assess hospitalization and death rates, quality of life,
self-management behaviors, social support, satisfaction with HF care, and depression
symptoms.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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