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

Mobilizing Peer Support for Effective Heart Failure Self-Management

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure, Congestive
• Intervention / Treatment: Behavioral: Interactive Voice Response System; Behavioral: Nurse-Led Group Clinic Visits

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 Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Self-Management Group Support and Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Re-hospitalization and death rates	Measured at Month 12
Total hospitalizations	Measured at Month 12
HF-specific quality of life	Measured at Months 6 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
HF self-management behaviors, treatment regimens, and perceived social support	Measured at Months 6 and 12
HF self-care self-efficacy and autonomous motivation	Measured at Months 6 and 12
Satisfaction with HF care	Measured at Months 6 and 12
Depressive symptoms	Measured at Months 6 and 12

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: M.E. Michele Heisler, MD, University of Michigan, Ann Arbor, Internal Medicine, General Medicine

Publications and helpful links

General Publications

• Heisler M, Halasyamani L, Cowen ME, Davis MD, Resnicow K, Strawderman RL, Choi H, Mase R, Piette JD. Randomized controlled effectiveness trial of reciprocal peer support in heart failure. Circ Heart Fail. 2013 Mar;6(2):246-53. doi: 10.1161/CIRCHEARTFAILURE.112.000147. Epub 2013 Feb 6.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: July 27, 2007
• First Submitted That Met QC Criteria: July 27, 2007
• First Posted (Estimate): July 30, 2007

Study Record Updates

• Last Update Posted (Estimate): June 18, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Heart Failure; Peer Support; Self Management
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 429; 1R01HL085420-01 (U.S. NIH Grant/Contract)