Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas (REMOTE-HF)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00415545
First received: December 21, 2006
Last updated: June 6, 2013
Last verified: June 2013

December 21, 2006
June 6, 2013
January 2007
January 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)
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Heart Failure, Congestive
  • 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.
  • 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.
  • Experimental: 1
    Fluid Watchers LITE program
    Intervention: Behavioral: Fluid Watchers LITE Educational Intervention
  • Experimental: 2
    Fluid Watchers PLUS program
    Intervention: Behavioral: Fluid Watchers PLUS Educational Intervention
  • No Intervention: 3
    Usual care control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
614
January 2013
January 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 information is only displayed when the study is recruiting subjects
United States
 
NCT00415545
423, R01HL083176, R01 HL083176-01A1
Yes
University of California, San Francisco
University of California, San Francisco
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Nursing Research (NINR)
Principal Investigator: Kathleen A. Dracup, DNSc University of California, San Francisco
University of California, San Francisco
June 2013

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