Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260650
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2005-11-29
Brief Title:
Patient Activation in High-Risk Patients With Heart Failure
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Heart PACT Patient Activation in High-Risk Patients With Heart Failure
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HeartPACT
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None