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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00260650
First received: November 29, 2005
Last updated: February 6, 2014
Last verified: March 2011
  Purpose

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 Intervention
Heart Failure
Behavioral: Heart PACT Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Heart PACT: Patient Activation in High-Risk Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • patient activation [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • self-management [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: September 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Heart PACT Program - patient activation intervention
Behavioral: Heart PACT Program
patient activation intervention
No Intervention: Arm 2
Usual Care

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 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.

Objectives:

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.

Methods:

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.

Status:

Completed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260650

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Martha J. Shively, PhD RN San Diego Veterans Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00260650     History of Changes
Other Study ID Numbers: NRI 04-252
Study First Received: November 29, 2005
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
heart failure, congestive
self-care
quality of life
health behavior

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014