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

Heart Failure, Congestive Clinical Trial

Official title:

Mobilizing Peer Support for Effective Heart Failure Self-Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508508
• Other study ID #: 429
• Secondary ID: 1R01HL085420-01
• Status: Completed
• Phase: N/A
• First received: July 27, 2007
• Last updated: June 17, 2013
• Start date: April 2007
• Est. completion date: October 2010

Study information

• Verified date: July 2011
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. Joseph Mercy Hospital	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-hospitalization and death rates		Measured at Month 12	No
Primary	Total hospitalizations		Measured at Month 12	No
Primary	HF-specific quality of life		Measured at Months 6 and 12	No
Secondary	HF self-management behaviors, treatment regimens, and perceived social support		Measured at Months 6 and 12	No
Secondary	HF self-care self-efficacy and autonomous motivation		Measured at Months 6 and 12	No
Secondary	Satisfaction with HF care		Measured at Months 6 and 12	No
Secondary	Depressive symptoms		Measured at Months 6 and 12	No