Clinical trial NCT00508508: Effectiveness of Peer Support in Improving Heart Failure Self-Management and Care
Official title: Mobilizing Peer Support for Effective Heart Failure Self-Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Keywords: Heart Failure
Peer Support
Self Management
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-07-30
Enrollment: 266
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Re-hospitalization and death rates
timeFrame: Measured at Month 12
measure: Total hospitalizations
timeFrame: Measured at Month 12
measure: HF-specific quality of life
timeFrame: Measured at Months 6 and 12
Secondary outcomes:
measure: HF self-management behaviors, treatment regimens, and perceived social support
timeFrame: Measured at Months 6 and 12
measure: HF self-care self-efficacy and autonomous motivation
timeFrame: Measured at Months 6 and 12
measure: Satisfaction with HF care
timeFrame: Measured at Months 6 and 12
measure: Depressive symptoms
timeFrame: Measured at Months 6 and 12
Other outcomes:
Locations:
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
Study officials:
affiliation: University of Michigan, Ann Arbor, Internal Medicine, General Medicine
name: M.E. Michele Heisler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.