The Congestive Heart Failure Adherence Redesign Trial
Completed · Phase 3
Conditions studied: Heart Failure, Congestive, Cardiovascular Diseases, Heart Diseases
In brief
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.
Key facts
- Study ID
- NCT01698242
- Run by
- Lynda Powell, PhD, MEd
- People needed
- 320
- Starts
- 2011-05-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2016-04-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- Participant has been diagnosed with Heart Failure (HF),
- Self reported family income is less than $30,000/year,
- Has experienced at least one hospitalization for acute, decompensated, HF within the previous 6 months based upon:
- Being admitted for symptoms of HF (ex: peripheral edema, shortness of breath and fatigue), and
- responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ACE Inhibitors, ARBs, or Beta blockers.
- 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.
- Age ≥ 18 years
- Currently resides in Cook County, Illinois.
- Speaks English or Spanish.
- The primary care provider (PCP) has consented and has no more than 12 patients enrolled.
- Completed the informed consent process.
- Successfully completed the 30-day run-in period and study baseline visit
You may not qualify if…
- Exclusion Criteria (PCP)
- Health providers will be excluded from enrollment if they are:
- Still in their residency or training period,
- A member of the CHART research staff.
- Exclusion Criteria (Patients)
- Patients will be excluded from enrollment if they have:
- An uncertain 12-month prognosis.
- Listed for imminent cardiac transplant.
- Has an advanced directive of "Do not resuscitate".
- Has uncertain 12-Month Prognosis, as adjudicated by the Principal Investigator
Where it is running
- Rush University Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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