Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas

Heart Failure, Congestive Clinical Trial

— REMOTE-HF  

Official title:

Improving Self Care Behavior and Outcomes in Rural Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415545
• Other study ID #: 423
• Secondary ID: R01HL083176R01HL
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2006
• Last updated: June 6, 2013
• Start date: January 2007
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: January 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

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 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.

Locations

Country	Name	City	State
United States	University of California, Davis	Davis	California
United States	University of Kentucky	Lexington	Kentucky
United States	Washoe Health Care System	Reno	Nevada

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization for heart failure and cardiac mortality		Measured at Year 2	No
Secondary	Heart failure-related emergency department visits (without hospitalization)		Measured at Year 2	No
Secondary	Unplanned physician visits		Measured at Year 2	No
Secondary	Heart failure severity (New York Heart Association [NYHA] class and brain natriuretic peptide)		Measured at Year 2	No
Secondary	Quality of life		Measured at Year 2	No