The Congestive Heart Failure Adherence Redesign Trial (CHART)

Lynda Powell, PhD, MEd

Status and phase: Completed; Phase 3

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

Treatments: Behavioral: Enhanced Training; Behavioral: Enhanced Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01698242

10030801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

2. Listed for imminent cardiac transplant.

3. Has an advanced directive of "Do not resuscitate".

4. Has uncertain 12-Month Prognosis, as adjudicated by the Principal Investigator

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

Enhanced Training

Experimental group

Description:

The Enhanced Training intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. Randomization occurs at the PCP-level, that is, patients are assigned to the Enhanced Training group only if their PCP has been enrolled and randomized to this group. Descriptions of the intervention on the PCP-level and patient-level are provided in the intervention section.

Treatment:

Behavioral: Enhanced Training

Enhanced Education

Active Comparator group

Description:

The Enhanced Education intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. The intervention strategy revolves around providing nominal information through the mail. Randomization occurs at the PCP-level; that is, patients are assigned to the Enhanced Education group only if their PCP already has been enrolled and randomized to this group. Description of the intervention on the PCP-level and patient-level is provided in the intervention section.

Treatment:

Behavioral: Enhanced Education