Patient Activation in High-Risk Patients With Heart Failure (Heart PACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00260650
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : September 30, 2014
Information provided by (Responsible Party):
VA Office of Research and Development

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 were patient activation (skills needed to maintain function, collaborate with providers, and access care), self-care management, hospitalizations and emergency department visits.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Heart PACT Program Not Applicable

Detailed Description:


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 the VA system with similar rates in the Medicare health care system. Few studies have examined whether chronic heart failure (HF) outcomes can be improved by increasing patient engagement (known as activation) in care and capabilities for self-care management.


The objective was to determine the efficacy of a patient activation (Heart PACT) intervention compared to usual care on activation, self-care management, hospitalizations and emergency room visits in patients with HF.


This study employed a randomized, 2-group, repeated-measures design at a single VA site. Following consent, 84 participants were stratified by activation level and randomly assigned to usual care (n = 41), or usual care plus the Heart PACT intervention (n = 43). The primary outcomes and measures were patient activation using the Patient Activation Measure (PAM); self-management using the Self-Care of Heart Failure Index (SCHFI) and the Medical Outcomes Study (MOS) Specific Adherence Scale; and hospitalizations and emergency room visits using self-report and VA databases. The Heart PACT intervention consisted of individual meetings and phone contacts over 6 months. The intervention leaders collaborated with patients to increase activation and improve HF self-management behaviors, such as adhering to medications and implementing health behavior goals. The primary analyses were 2 (group: control vs. intervention) x 3 (time) repeated measures analyses of variance.



Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Heart PACT: Patient Activation in High-Risk Patients With Heart Failure
Study Start Date : September 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Arm 1
Heart PACT Program - patient activation intervention
Behavioral: Heart PACT Program
patient activation intervention

No Intervention: Arm 2
Usual Care

Primary Outcome Measures :
  1. patient activation [ Time Frame: baseline, 3 months, 6 months ]

Secondary Outcome Measures :
  1. self-management [ Time Frame: baseline, 3 months, 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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 Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00260650

United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development

McKibbin CL, Shively M, Glaser D, Kodiath M, Kelly A, Bormann JE, Stepnowsky C, Smith T. Readiness to change in heart failure patients: Adaptation of a pain readiness to change measure. Clinical Gerontologist. 2007 Oct 1; 31(2):33-43.

Responsible Party: VA Office of Research and Development Identifier: NCT00260650     History of Changes
Other Study ID Numbers: NRI 04-252
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014

Keywords provided by VA Office of Research and Development:
heart failure, congestive
quality of life
health behavior

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases