Viewing Study NCT00508508



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Last Modification Date: 2024-10-26 @ 9:35 AM
Study NCT ID: NCT00508508
Status: COMPLETED
Last Update Posted: 2013-06-18
First Post: 2007-07-27

Brief Title: Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care
Sponsor: University of Michigan
Organization: University of Michigan

Study Overview

Official Title: Mobilizing Peer Support for Effective Heart Failure Self-Management
Status: COMPLETED
Status Verified Date: 2011-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R01HL085420-01 NIH None httpsreporternihgovquickSearch1R01HL085420-01