An interventional study of Interactive Voice Response System and Nurse-Led Group Clinic Visits in Heart Failure, Congestive, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-06-18.
Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 266 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: IVR
Behavioral: Interactive Voice Response System
Behavioral: Nurse-Led Group Visits
Behavioral: Nurse-Led Group Clinic Visits
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.
Also known as: Telephone Peer-Support
At Months 1, 3, and 6, participants will take part in group visits led by nurses to discuss HF self-management strategies.
Also known as: Self-Management Group Support and Training
Re-hospitalization and death rates
Time frame: Measured at Month 12
Total hospitalizations
Time frame: Measured at Month 12
HF-specific quality of life
Time frame: Measured at Months 6 and 12
HF self-management behaviors, treatment regimens, and perceived social support
Time frame: Measured at Months 6 and 12
HF self-care self-efficacy and autonomous motivation
Time frame: Measured at Months 6 and 12
Satisfaction with HF care
Time frame: Measured at Months 6 and 12
Depressive symptoms
Time frame: Measured at Months 6 and 12
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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University of Michigan