Self-monitoring and timely response by heart failure (HF) patients to worsening symptoms caused by fluid overload (the primary reason for hospital readmissions) are important to minimize myocardial damage. However, patients often ignore symptoms or are reluctant to seek care. Disease management models have improved outcomes but are limited to major urban centers and are unavailable in rural areas. These programs are also based on treatment guidelines for systolic HF (SHF) and not patients who suffer from diastolic HF (DHF). PURPOSE: We propose to test the effects on clinical outcomes (HF-related hospital readmissions, mortality, HF severity, quality of life [QOL]), self-care monitoring and behaviors, care-seeking behaviors, patient knowledge and cost) of 2 doses of an easily administered education intervention focused on fluid weight management (Fluid Watchers) designed specifically for rural patients. METHODS: 710 HF subjects will be randomized to 1 of 3 groups (usual care [UC], Fluid Watchers LITE or PLUS) at rural sites in California, Kentucky and Nevada. Patients in Fluid Watchers LITE and PLUS groups will receive counseling about HF and self-monitoring, and coaching on seeking care. The PLUS group will also receive additional counseling, audio tapes and telephone followup. Data will be collected at baseline, 3, 12 and 24 months. Instruments include a knowledge questionnaire, HF Self-Care Behavior Scale, and The Minnesota Living with Heart FailureQOL instrument. Diaries will be used to measure adherence and healthcare provider contacts (self-care monitoring and care seeking respectively). ANALYSES: Chi-squares, t-tests, multivariate regressions, cox proportional hazards and mixed models analyses will be used. Program costs and cost effectiveness (net cost per hospitalization averted or year of life saved) will be calculated. SIGNIFICANCE: This study is unique because it is a single component intervention with 2 doses designed for rural or resource-scarce settings, conducted in patients with both DHF and SHF, with long term follow-up over 2 years. If effective, this intervention would be broadly applicable and lend valuable insight about treatment of HF in rural settings. LAY: Self monitoring and timely response to symptoms by HF patients is important to minimize heart damage. HF interventions have not been developed for resource scarce rural areas. The intervention tested here could help patients with HF in rural areas avoid hospitalizations.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL083176-05
Application #
7810591
Study Section
Health Services Organization and Delivery Study Section (HSOD)
Program Officer
Cooper, Lawton S
Project Start
2006-08-01
Project End
2013-04-30
Budget Start
2010-05-01
Budget End
2013-04-30
Support Year
5
Fiscal Year
2010
Total Cost
$661,493
Indirect Cost
Name
University of California San Francisco
Department
Other Health Professions
Type
Schools of Nursing
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
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