Heart Failure, Congestive Clinical Trial
Official title:
Improving Self Care Behavior and Outcomes in Rural Patients With Heart Failure
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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