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Reduction in Hospitalizations in Low-Income Patients With Heart Failure
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Rush University Medical Center
Chicago, Illinois, United States
Start Date
May 1, 2011
Primary Completion Date
December 1, 2015
Completion Date
December 1, 2015
Last Updated
April 19, 2016
320
ACTUAL participants
Enhanced Training
BEHAVIORAL
Enhanced Education
BEHAVIORAL
Lead Sponsor
Lynda Powell, PhD, MEd
Collaborators
NCT06909773
NCT06505109
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06189313