NCT00415545

Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas

Improving Self Care Behavior and Outcomes in Rural Patients With Heart Failure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 614 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Heart failure patients living in rural areas usually do not have adequate access to formal heart failure management programs. This study will compare two versions of an educational intervention aimed at improving self-care management techniques among individuals with heart failure who are living in rural areas.

Detailed description

Heart failure 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 and seek out medical attention when appropriate. Swelling and weight gain are common heart failure symptoms that indicate excess fluid buildup in the body and worsening heart function. Closely monitoring and responding to these symptoms can be a strategic way to prevent heart failure exacerbations. However, many patients ignore symptoms and are reluctant to seek care. Specialized monitoring programs can help heart failure patients to respond more appropriately to their symptoms. Traditionally, heart failure patients living in rural areas have had limited access to formal monitoring programs. Fluid Watchers is a program designed to help heart failure patients living in rural areas improve self-management of symptoms, specifically excess fluid buildup. The purpose of this study is to compare the effectiveness of two versions of Fluid Watchers at improving the hospitalization and death rates of individuals with heart failure who live in rural areas. In this 2-year study, 710 participants will be randomly assigned to either the Fluid Watchers LITE program, the Fluid Watchers PLUS program, or a usual care control group. Individuals in both Fluid Watchers groups will attend a one-on-one educational session that will include heart failure counseling and information on self-monitoring and care-seeking strategies. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis. All participants will record self-monitoring adherence and contact with healthcare providers. Outcome measures will be assessed during either clinic or home visits at study entry and Months 3, 12, and 24, and will include number of emergency department visits, number of physician visits, heart failure severity, and quality of life.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
BEHAVIORAL	Fluid Watchers LITE Educational Intervention	Patients in Fluid Watchers LITE will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written material, a diary, a scale and a telephone follow-up to answer any questions they might have about the educational session.
BEHAVIORAL	Fluid Watchers PLUS Educational Intervention	Patients in Fluid Watchers PLUS will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written materials, a diary, a scale, an audio tape of the session and telephone followup. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis, as compared to participants in the LITE program.

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-01-01
• Completion: 2013-01-01
• First posted: 2006-12-25
• Last updated: 2013-06-07

Locations

3 sites across 1 country: United States