the congestive heart failure adherence redesign trial

Conditions: Heart Failure, Congestive; Cardiovascular Diseases; Heart Diseases

Summary: the purpose of this study is to test whether a culturally sensitive self-management (sm) intervention, compared to an education only control, will reduce all-cause hospital days in patients with mild to moderate heart failure and household income less than $30,000 per year.

the purpose of the chart research study is to assess the value of a novel multi-level intervention for low-income patients recently hospitalized with heart failure relative to providing education alone (both strategies are described in detail in the intervention section below). the investigators refer to their novel intervention strategy as 'enhanced training' and their education-only strategy the investigators refer to as 'enhanced education'. these two strategies of participant follow-up will be assessed and compared by analyzing patient's all-cause hospital days over a 2.5-year follow-up period (the investigators note that, for patients with heart failure, the average number of such all-cause hospital days over a 2.5-year period has tripled over the past 25 years). the enhanced training strategy aims to improve patient receipt of evidence-based therapy by: 1) activating patients using a culturally sensitive approach that might better resonate with the investigators predominantly urban, african-american and hispanic, target population; 2) providing timely and useful information to the primary care provider; and 3) promoting effective communication between patients and their primary care provider. the enhanced education strategy is less intrusive and aims to provide patients and primary care providers with appropriate educational materials via mail. the primary aims of this research study are to determine if enhanced training and/or enhanced education will improve: patient adherence to drug therapy and salt restriction, health care provider adherence to evidence-based guidelines, and patient functional capacity and quality of life. secondary aims will include assessing impact of the interventions on crp and bnp, which are two key biomarkers of heart failure progression.

Eligibility criteria:
inclusion criteria: inclusion criteria (pcp) 1. provider must be the health professional who is managing the potential patient enrollee's heart failure medication(s). inclusion criteria (patients) 1. participant has been diagnosed with heart failure (hf), 2. self reported family income is less than $30,000/year, 3. has experienced at least one hospitalization for acute, decompensated, hf within the previous 6 months based upon: 1. being admitted for symptoms of hf (ex: peripheral edema, shortness of breath and fatigue), and 2. responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ace inhibitors, arbs, or beta blockers. 4. has evidence of systolic dysfunction, defined by an ejection \<50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year. 5. age ≥ 18 years 6. currently resides in cook county, illinois. 7. speaks english or spanish. 8. the primary care provider (pcp) has consented and has no more than 12 patients enrolled. 9. completed the informed consent process. 10. successfully completed the 30-day run-in period and study baseline visit exclusion criteria: exclusion criteria (pcp) health providers will be excluded from enrollment if they are: 1. still in their residency or training period, 2. a member of the chart research staff. exclusion criteria (patients) patients will be excluded from enrollment if they have: 1. an uncertain 12-month prognosis. 1. listed for imminent cardiac transplant. 2. has an advanced directive of "do not resuscitate". 3. has uncertain 12-month prognosis, as adjudicated by the principal investigator

Keywords: heart failure self-management behavioral clinical trial