Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018005
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2001-06-26
Brief Title:
A Self-Management Intervention for Mild to Moderate Heart Failure
Sponsor:
Lynda Powell PhD MEd
Organization:
Rush University Medical Center
Study Overview
Official Title:
Heart Failure Adherence and Retention Trial HART
Status:
COMPLETED
Status Verified Date:
2012-10
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:
HART
Brief Summary:
This study will test whether a self-management SM intervention compared to usual care will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure
Detailed Description:
BACKGROUND
Heart failure is a major disabling disease for American adults affecting an estimated 49 million individuals Heart failure is associated with enormous health care expenditures This is because it is a progressive chronic condition that is characterized by disabling symptoms that limit independence and result in multiple hospitalizations and referrals to long-term care The emergence of heart failure as a major public health problem is related to the unintended result of both an aging population and the success in reducing mortality from cardiovascular disease Non-adherence to medications is a key problem in the treatment of heart failure with adherence rates ranging from 20 to 90 There is a clear need therefore to develop interventions that improve adherence in patients with heart failure
DESIGN NARRATIVE
This is a single-site partially blinded randomized clinical trial of 900 patients with systolic or diastolic dysfunction and New York Heart Association NYHA functional class II or III Patients will be recruited over a period of 2 years from seven hospitals Patients will be randomly assigned to either a SM intervention or attention control The SM group will meet 18 times for 2 hours over 1 year These group sessions will teach patients how to use five basic self-management skills self-monitoring environmental restructuring social support cognitive restructuring and the relaxation response to help build self-efficacy and maintain it after the treatment has been discontinued The attention control arm will consist of an educational intervention which includes 18 mailings of the American Heart Association Tip Sheets over the course of the first year plus a telephone follow-up with the patient after each mailing to check receipt and comprehension of the Tip Sheet and to address any questions about the Tip Sheet Treatment effects will be evaluated using the primary outcome of hospitalization for heart failure or death and the secondary outcomes of progression of heart failure quality of life and health care costs Potential mediators of effectiveness will include improved adherence and improved psychosocial function
Heart failure is a major disabling disease for American adults affecting an estimated 49 million individuals Heart failure is associated with enormous health care expenditures This is because it is a progressive chronic condition that is characterized by disabling symptoms that limit independence and result in multiple hospitalizations and referrals to long-term care The emergence of heart failure as a major public health problem is related to the unintended result of both an aging population and the success in reducing mortality from cardiovascular disease Non-adherence to medications is a key problem in the treatment of heart failure with adherence rates ranging from 20 to 90 There is a clear need therefore to develop interventions that improve adherence in patients with heart failure
DESIGN NARRATIVE
This is a single-site partially blinded randomized clinical trial of 900 patients with systolic or diastolic dysfunction and New York Heart Association NYHA functional class II or III Patients will be recruited over a period of 2 years from seven hospitals Patients will be randomly assigned to either a SM intervention or attention control The SM group will meet 18 times for 2 hours over 1 year These group sessions will teach patients how to use five basic self-management skills self-monitoring environmental restructuring social support cognitive restructuring and the relaxation response to help build self-efficacy and maintain it after the treatment has been discontinued The attention control arm will consist of an educational intervention which includes 18 mailings of the American Heart Association Tip Sheets over the course of the first year plus a telephone follow-up with the patient after each mailing to check receipt and comprehension of the Tip Sheet and to address any questions about the Tip Sheet Treatment effects will be evaluated using the primary outcome of hospitalization for heart failure or death and the secondary outcomes of progression of heart failure quality of life and health care costs Potential mediators of effectiveness will include improved adherence and improved psychosocial function
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL065547 | NIH | None | httpsreporternihgovquickSearchR01HL065547 |