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

NCT ID: NCT00508508

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-10-31

Brief 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.

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.

Conditions

Heart Failure, Congestive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

Behavioral: IVR

Group Type: EXPERIMENTAL

Interactive Voice Response System

Intervention Type: BEHAVIORAL

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

Behavioral: Nurse-Led Group Visits

Group Type: EXPERIMENTAL

Nurse-Led Group Clinic Visits

Intervention Type: BEHAVIORAL

At Months 1, 3, and 6, participants will take part in group visits led by nurses to discuss HF self-management strategies.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Telephone Peer-Support; Self-Management Group Support and Training

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Mase

Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M.E. Michele Heisler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, Ann Arbor, Internal Medicine, General Medicine

Locations

St. Joseph Mercy Hospital

Ypsilanti, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23388114 (View on PubMed)

Other Identifiers

1R01HL085420-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

429

Identifier Type: -

Identifier Source: org_study_id