A Phase 3 interventional study of Fluid Watchers LITE Educational Intervention and Fluid Watchers PLUS Educational Intervention in Heart Failure, Congestive, sponsored by University of California, San Francisco. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-07.
Sponsored by University of California, San Francisco · Phase 3, Interventional, and Health services research
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 614 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
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Exclusion Criteria:
Fluid Watchers LITE program
Behavioral: Fluid Watchers LITE Educational Intervention
Fluid Watchers PLUS program
Behavioral: Fluid Watchers PLUS Educational Intervention
Usual care control group
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.
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.
Hospitalization for heart failure and cardiac mortality
Time frame: Measured at Year 2
Heart failure-related emergency department visits (without hospitalization)
Time frame: Measured at Year 2
Unplanned physician visits
Time frame: Measured at Year 2
Heart failure severity (New York Heart Association [NYHA] class and brain natriuretic peptide)
Time frame: Measured at Year 2
Quality of life
Time frame: Measured at Year 2
The record gives a start of Jan 2007, a primary completion of Jan 2012 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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