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Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rebecca Mase, University of Michigan
ClinicalTrials.gov Identifier:
NCT00508508
First received: July 27, 2007
Last updated: June 17, 2013
Last verified: July 2011
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mobilizing Peer Support for Effective Heart Failure Self-Management

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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 ]

Enrollment: 266
Study Start Date: April 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Other Name: Telephone Peer-Support
Experimental: 2
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508508

Locations
United States, Michigan
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: M.E. Michele Heisler, MD University of Michigan, Ann Arbor, Internal Medicine, General Medicine
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rebecca Mase, Project Manager, University of Michigan
ClinicalTrials.gov Identifier: NCT00508508     History of Changes
Other Study ID Numbers: 429, 1R01HL085420-01, 1 R01 HL085420-01
Study First Received: July 27, 2007
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Heart Failure
Peer Support
Self Management

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014