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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart PACT Program
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring heart failure, congestive, self-care, quality of life, health behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Heart PACT Program

Usual Care

Arm Description

Heart PACT Program - patient activation intervention

Usual Care

Outcomes

Primary Outcome Measures

patient activation

Secondary Outcome Measures

self-management

Full Information

First Posted
November 29, 2005
Last Updated
October 4, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00260650
Brief Title
Patient Activation in High-Risk Patients With Heart Failure
Acronym
HeartPACT
Official Title
Heart PACT: Patient Activation in High-Risk Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, congestive, self-care, quality of life, health behavior

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart PACT Program
Arm Type
Experimental
Arm Description
Heart PACT Program - patient activation intervention
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Heart PACT Program
Intervention Description
patient activation intervention
Primary Outcome Measure Information:
Title
patient activation
Time Frame
baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
self-management
Time Frame
baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy J Gardetto, PhD NP
Organizational Affiliation
VASDHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18226772
Citation
Riegel B, Moser DK, Rayens MK, Carlson B, Pressler SJ, Shively M, Albert NM, Armola RR, Evangelista L, Westlake C, Sethares K; Heart Failure Trialists Collaborators. Ethnic differences in quality of life in persons with heart failure. J Card Fail. 2008 Feb;14(1):41-7. doi: 10.1016/j.cardfail.2007.09.008.
Results Reference
background
Citation
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.
Results Reference
background

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Patient Activation in High-Risk Patients With Heart Failure

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