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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00260650 |
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 |
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 |
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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%)
Exclusion Criteria:
Patients will be excluded if they meet any of these criteria:
Contact: Carolyn B Larson, BSN RN | (858) 552-8585 ext 4374 |
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 |
Principal Investigator: | Martha J. Shively, PhD RN | VA San Diego Healthcare System |
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 |
heart failure, congestive self-care quality of life health behavior |
Heart Failure Heart Diseases Quality of Life |
Cardiovascular Diseases |