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.|
|ClinicalTrials.gov Identifier: NCT00260650|
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : September 30, 2014
|Condition or disease||Intervention/treatment|
|Heart Failure||Behavioral: Heart PACT Program|
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|
|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|
|Primary Completion Date :||September 2010|
|Study Completion Date :||September 2010|
Experimental: Arm 1
Heart PACT Program - patient activation intervention
Behavioral: Heart PACT Program
patient activation intervention
No Intervention: Arm 2
- patient activation [ Time Frame: baseline, 3 months, 6 months ]
- self-management [ Time Frame: baseline, 3 months, 6 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00260650
|United States, California|
|VA San Diego Healthcare System|
|San Diego, California, United States, 92161|