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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Behavioral: Fluid Watchers LITE Educational Intervention
* Behavioral: Fluid Watchers PLUS Educational Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fluid Watchers LITE program | Behavioral: Fluid Watchers LITE Educational Intervention<br>* 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.<br>|
| Experimental: 2<br>Fluid Watchers PLUS program | Behavioral: Fluid Watchers PLUS Educational Intervention<br>* 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.<br>|
| No Intervention: 3<br>Usual care control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for heart failure and cardiac mortality |  | Measured at Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure-related emergency department visits (without hospitalization) |  | Measured at Year 2 | 
| Unplanned physician visits |  | Measured at Year 2 | 
| Heart failure severity (New York Heart Association [NYHA] class and brain natriuretic peptide) |  | Measured at Year 2 | 
| Quality of life |  | Measured at Year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Patient Education