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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00415545
First Posted: December 25, 2006
Last Update Posted: June 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition Intervention Phase
Heart Failure, Congestive Behavioral: Fluid Watchers LITE Educational Intervention Behavioral: Fluid Watchers PLUS Educational Intervention Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Hospitalization for heart failure and cardiac mortality [ Time Frame: Measured at Year 2 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 614
Study Start Date: January 2007
Study Completion Date: January 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Experimental: 2
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Kathleen A. Dracup, DNSc University of California, San Francisco
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00415545     History of Changes
Other Study ID Numbers: 423
R01HL083176 ( U.S. NIH Grant/Contract )
R01HL083176-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 21, 2006
First Posted: December 25, 2006
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by University of California, San Francisco:
Heart Failure
Patient Education

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases