Status:
COMPLETED
Patient Activation in High-Risk Patients With Heart Failure
Lead Sponsor:
VA Office of Research and Development
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study was to determine the efficacy of a self-management program, called the Heart PACT Program, compared to usual health care in patients with heart failure. Outcomes measured wer...
Detailed Description
Background: Heart failure (HF) places an enormous burden on patients, their families, health care systems and society. Readmission for HF occurs within 30 days following 20 percent of discharges from...
Eligibility Criteria
Inclusion
- This study was done at the VA San Diego Healthcare System only. Participants must live in San Diego and meet all of the following inclusion criteria:
- Has VA primary care provider for heart failure care
- Hospitalization or emergency department visit for treatment of HF within past 12 months. Hospital discharge must be at least one month prior to study enrollment.
- Hospitalization diagnoses may include: acute myocardial infarction (MI) or acute coronary syndrome with LV dysfunction (EF \<40%); status post coronary bypass graft surgery with LV dysfunction (EF \< 40%)
- Documented heart failure (systolic or diastolic dysfunction) by echocardiogram or physician diagnosis and Stage C heart failure
- 18 years of age or older
- Read and speak English
- Have telephone access
Exclusion
- Patients will be excluded if they meet any of these criteria:
- Are unable to give written informed consent
- Have had a major acute medical problem (e.g., stroke, acute MI, CABG, or percutaneous intervention), or are considered medically unstable within the prior month
- Have a history of severe pulmonary disease, renal disease requiring dialysis, severe hepatic disease, severe aortic or mitral stenosis, constrictive pericarditis, or cardiac transplant
- Have a left ventricular assist device (LVAD)
- Have a bi-ventricular pacemaker or implantable cardioverter defibrillator (ICD) placement in the past 1 month
- Have a life expectancy of less than 1 year
- Have current acute psychiatric problems, active substance abuse or homelessness
- Are participating in an ongoing clinical drug trial.
- Enrolled in specialty HF care via the HF Program or telehealth
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00260650
Start Date
September 1 2006
End Date
September 1 2010
Last Update
October 8 2019
Active Locations (1)
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1
VA San Diego Healthcare System
San Diego, California, United States, 92161