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Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), July 2008
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00508508
  Purpose

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.


Condition Intervention
Heart Failure, Congestive
Behavioral: Interactive Voice Response System
Behavioral: Nurse-Led Group Clinic Visits

MedlinePlus related topics: Heart Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Mobilizing Peer Support for Effective Heart Failure Self-Management

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Re-hospitalization and death rates [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Total hospitalizations [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • HF-specific quality of life [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HF self-management behaviors, treatment regimens, and perceived social support [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • HF self-care self-efficacy and autonomous motivation [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Satisfaction with HF care [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: April 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Behavioral: IVR
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.
2: Experimental
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.

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 socio-economically 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with HF
  • Inpatient Hospital stay or Heart Failure Clinic Appointment

Exclusion Criteria:

  • Serious mental illness or cognitive dysfunction
  • Does not speak English fluently
  • Receives most HF care outside the St. Joseph Mercy Health System
  • Unable to use the telephone to access the IVR system
  • Will be discharged to a long-term care or hospice facility
  • End-stage cancer or other end-stage condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508508

Contacts
Contact: Rebecca A. Mase, MSW 734-845-3973 rmase@umich.edu
Contact: M.E. Michele Heisler, MD 734-845-3614 mheisler@umich.edu

Locations
United States, Michigan
St. Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Rebecca A. Mase, MSW     734-845-3973     rmase@umich.edu    
Principal Investigator: Lakshmi Halasyamani, MD            
Sub-Investigator: Mark Cowen, MD, MPH            
Sub-Investigator: Marlo Leonen, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: M.E. Michele Heisler, MD University of Michigan, Ann Arbor, Internal Medicine, General Medicine
  More Information

Responsible Party: University of Michigan ( M.E. Michele Heisler, MD, Principal Investigator )
Study ID Numbers: 429, 1 R01 HL085420-01
Study First Received: July 27, 2007
Last Updated: July 28, 2008
ClinicalTrials.gov Identifier: NCT00508508  
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Heart Failure
Peer Support
Self Management

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009