Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00508508|
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : June 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Behavioral: Interactive Voice Response System Behavioral: Nurse-Led Group Clinic Visits||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mobilizing Peer Support for Effective Heart Failure Self-Management|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Behavioral: Interactive Voice Response System
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.
Other Name: Telephone Peer-Support
Behavioral: Nurse-Led Group Visits
Behavioral: Nurse-Led Group Clinic Visits
At Months 1, 3, and 6, participants will take part in group visits led by nurses to discuss HF self-management strategies.
Other Name: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508508
|United States, Michigan|
|St. Joseph Mercy Hospital|
|Ypsilanti, Michigan, United States, 48197|
|Principal Investigator:||M.E. Michele Heisler, MD||University of Michigan, Ann Arbor, Internal Medicine, General Medicine|