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Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas (REMOTE-HF)
This study is currently recruiting participants.
Study NCT00415545   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: December 21, 2006   Last Updated: July 10, 2009   History of Changes

December 21, 2006
July 10, 2009
January 2007
April 2012   (final data collection date for primary outcome measure)
Hospitalization for heart failure and cardiac mortality [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
Hospitalization for heart failure and cardiac mortality (measured at Month 24)
Complete list of historical versions of study NCT00415545 on ClinicalTrials.gov Archive Site
  • Heart failure-related emergency department visits (without hospitalization) [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Unplanned physician visits [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Heart failure severity (New York Heart Association [NYHA] class and brain natriuretic peptide) [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Heart failure-related emergency department visits (without hospitalization)
  • Unplanned physician visits
  • Heart failure severity (New York Heart Association [NYHA] class and brain naturetic peptide)
  • Quality of life (all measured at Month 24)
 
Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas
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.

Phase III
Interventional
Health Services Research, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Heart Failure, Congestive
  • Behavioral: Fluid Watchers LITE Educational Intervention
  • Behavioral: Fluid Watchers PLUS Educational Intervention
  • Experimental: Fluid Watchers LITE program
  • Experimental: Fluid Watchers PLUS program
  • No Intervention: Usual care control group
Caldwell MA, Peters KJ, Dracup KA. A simplified education program improves knowledge, self-care behavior, and disease severity in heart failure patients in rural settings. Am Heart J. 2005 Nov;150(5):983.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
710
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kathleen A. Dracup, DNSc 415-476-1805 kathy.dracup@nursing.ucsf.edu
Contact: Jessica Zegre, MS 415-476-4745 jessica.zegre@nursing.ucsf.edu
United States
 
NCT00415545
Kathleen Dracup/Principal Investigator, University of California, San Francisco
423, R01 HL083176-01A1
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Nursing Research (NINR)
Principal Investigator: Kathleen A. Dracup, DNSc University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP