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Patient Activation in High-Risk Patients With Heart Failure (Heart PACT)
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, October 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00260650
  Purpose

The purpose of this study is 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 will be 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

MedlinePlus related topics: Heart Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Heart PACT: Patient Activation in High-Risk Patients With Heart Failure

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 ]

Estimated Enrollment: 80
Study Start Date: August 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Heart PACT Program - patient activation intervention
Behavioral: Heart PACT Program
patient activation intervention
2: No Intervention
Usual Care

Detailed Description:

Background:

Heart failure (HF) care exemplifies efforts to improve chronic care over the past decade. Two of the most promising approaches, disease management and the Chronic Care Model, have evidenced success with heart failure patients but have not fully explored patients' engagement or activation in their own care.

Objectives:

The objective of this study is to determine the efficacy of a patient activation intervention (called Heart PACT Program) compared to usual care on activation, self-care management, and hospitalizations and emergency department (ED) visits in HF patients at high risk for hospital readmission. The investigators hypothesize that participants in the Heart PACT Program, as compared to usual care, will demonstrate improved activation, better self-care management, and fewer readmissions and ED visits.

Methods:

This study is a 3-year, randomized, 2-group, repeated-measures design. Following eligibility screening and consent, 80 patients will be stratified by activation level and randomly assigned to usual care (n = 40), or the activation intervention/Heart PACT Program (n = 40). The primary outcome variables are patient activation using the Patient Activation Measure (PAM) (Hibbard et al., 2005), self-care using the Self-Care for Heart Failure Index (SCHFI) (Riegel et al., 2004), and resource use (hospital readmissions and ED visits) collected from VHA Medical SAS Inpatient and Outpatient Datasets. Outcomes will be measured at baseline, 3 months and 6 months. Resource use will be tracked for 1 year before and after enrollment. The intervention consists of 4 individual meetings/clinic appointments and phone call follow-up over 6 months. At the first individual meeting, the intervention leaders assess the patient's level of activation: stage 1 or 2 (low activation), stage 3 (medium), or stage 4 (high) based on the patient's PAM score and a brief interview. The intervention leaders then collaborate with patients to improve activation and self-management of heart failure: adhering to medications; monitoring weight, blood pressure, and symptoms; and implementing health behavior goals, e.g., weight, diet or activity changes. The primary analysis will be a randomized 2 (group: control vs. intervention) x 3 (time) repeated measures analysis of variance.

Status:

Enrollment started 9/06. 57 participants have completed baseline assessments, 48 completed 3 month follow-up, 40 completed 6 month follow-up.

  Eligibility

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

Inclusion Criteria:

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

Contacts
Contact: Carolyn B Larson, BSN RN (858) 552-8585 ext 4374

Locations
United States, California
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact: Carolyn B Larson, BSN RN     858-552-8585 ext 4374        
Principal Investigator: Martha J. Shively, PhD RN            
Sub-Investigator: Nancy Gardetto, MSN NP            
Sponsors and Collaborators
Investigators
Principal Investigator: Martha J. Shively, PhD RN VA San Diego Healthcare System
  More Information

Publications of Results:
Responsible Party: Department of Veterans Affairs ( Shively, Martha - Principal Investigator )
Study ID Numbers: NRI 04-252
Study First Received: November 29, 2005
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00260650  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Quality of Life

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009