Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas (REMOTE-HF)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 3

Conditions: Heart Failure, Congestive

Treatments: Behavioral: Fluid Watchers PLUS Educational Intervention; Behavioral: Fluid Watchers LITE Educational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00415545

R01HL083176-01A1 (U.S. NIH Grant/Contract)

R01HL083176 (U.S. NIH Grant/Contract)

423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 614 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized for heart failure in the 6 months prior to study entry
• Able to read and write English
• Lives independently

Exclusion criteria

• Current participation in a heart failure management program
• Impaired cognition
• Serious co-morbidity

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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614 participants in 3 patient groups

1

Experimental group

Description:

Fluid Watchers LITE program

Treatment:

Behavioral: Fluid Watchers LITE Educational Intervention

2

Experimental group

Description:

Fluid Watchers PLUS program

Treatment:

Behavioral: Fluid Watchers PLUS Educational Intervention

3

No Intervention group

Description:

Usual care control group