Clinical trial NCT01698242: The Congestive Heart Failure Adherence Redesign Trial
Official title: Reduction in Hospitalizations in Low-Income Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure, Congestive
Cardiovascular Diseases
Heart Diseases
Keywords: Heart failure
Self-Management
Behavioral Clinical Trial
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Cook County Health
name: Sinai Health System
name: University of Illinois at Chicago
First posted: 2012-10-02
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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

Primary outcomes:
measure: Total number of all cause hospitalization days
timeFrame: Measured over the 30 month patient participant follow-up period
Secondary outcomes:
measure: Total number of heart failure related hospitalization days
timeFrame: measured over the 30 month patient participant follow-up period
measure: Health Care Costs
timeFrame: Measured over the 30 monthstudy follow-up period
measure: Distance traveled during th Six-Minute Walk test
timeFrame: This test is administered during in-person participant assessment visits conducted at baseline and at 6 and 30 months following treatment assignmentMeasured over/after 30 months
measure: The Kansas City Cardiomyopathy Questionnaire
timeFrame: This questionnaire is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: Patient Medication Adherence
timeFrame: Adherence is measured at baseline and at 6 and 30 months following treatment assignment
measure: CALS Food Frequency Questionnaire (Salt Intake)
timeFrame: This questionnaire is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: Self-Efficacy of Heart Failure Self-Management
timeFrame: This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: EQ-5D Visual Analog Scale (VAS) with Time Trade-Off (TTO) Utility Score
timeFrame: This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: Biomarkers of heart failure progression
timeFrame: Assessed during in-person participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: PHQ9 (Depression)
timeFrame: This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: Past Stressor Events
timeFrame: This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: Traumatic Stress Survey (Composite International Diagnostic Interview)
timeFrame: This survey that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: PCL-Civilian Short Form
timeFrame: This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: Modified Global Adherence Indicator (mGAI3)
timeFrame: This is assessed at baseline and at 6 and 30 months following participant treatment assignment.
measure: PCP Adherence to blood pressure goal
timeFrame: Patient participant blood pressure is assessed during in-person participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.
measure: Total number of heart failure hospitalizations and emergency room visits.
timeFrame: Measured over the 30 month patient participant follow-up period.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Chairperson and Professor
name: Lynda H. Powell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calvin JE, Shanbhag S, Avery E, Kane J, Richardson D, Powell L. Adherence to evidence-based guidelines for heart failure in physicians and their patients: lessons from the Heart Failure Adherence Retention Trial (HART). Congest Heart Fail. 2012 Mar-Apr;18(2):73-8. doi: 10.1111/j.1751-7133.2011.00263.x. Epub 2011 Nov 3.
citation: Powell LH, Calvin JE Jr, Mendes de Leon CF, Richardson D, Grady KL, Flynn KJ, Rucker-Whitaker CS, Janssen I, Kravitz G, Eaton C; Heart Failure Adherence and Retention Trial Investigators. The Heart Failure Adherence and Retention Trial (HART): design and rationale. Am Heart J. 2008 Sep;156(3):452-60. doi: 10.1016/j.ahj.2008.05.011.
citation: de Leon CF, Grady KL, Eaton C, Rucker-Whitaker C, Janssen I, Calvin J, Powell LH. Quality of life in a diverse population of patients with heart failure: BASELINE FINDINGS FROM THE HEART FAILURE ADHERENCE AND RETENTION TRIAL (HART). J Cardiopulm Rehabil Prev. 2009 May-Jun;29(3):171-8. doi: 10.1097/HCR.0b013e31819a0266.
citation: Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.
citation: Rucker-Whitaker C, Flynn KJ, Kravitz G, Eaton C, Calvin JE, Powell LH. Understanding African-American participation in a behavioral intervention: results from focus groups. Contemp Clin Trials. 2006 Jun;27(3):274-86. doi: 10.1016/j.cct.2005.11.006. Epub 2006 Jan 19.