Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas (REMOTE-HF)
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|ClinicalTrials.gov Identifier: NCT00415545|
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : June 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Behavioral: Fluid Watchers LITE Educational Intervention Behavioral: Fluid Watchers PLUS Educational Intervention||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||614 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Improving Self Care Behavior and Outcomes in Rural Patients With Heart Failure|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2013|
Fluid Watchers LITE program
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.
Fluid Watchers PLUS program
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.
No Intervention: 3
Usual care control group
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415545
|United States, California|
|University of California, Davis|
|Davis, California, United States, 95817|
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40526|
|United States, Nevada|
|Washoe Health Care System|
|Reno, Nevada, United States, 89523|
|Principal Investigator:||Kathleen A. Dracup, DNSc||University of California, San Francisco|