Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293852
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2006-02-17
Brief Title:
Collaborative Care for Heart Failure Patients With the Metabolic Syndrome
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Collaborative Care for Heart Failure Patients With the Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2020-02
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:
None
Brief Summary:
Heart failure is a condition where the heart does not pump enough blood to the rest of the body People with heart failure may have another condition called the metabolic syndrome having excess fat in the belly high blood pressure high fat in the blood low level of good cholesterol and high blood sugar People who have both heart failure and the metabolic syndrome often see many doctors A new clinic has been formed at Ben Taub General Hospital that includes a specialist in heart failure cardiologist and in the metabolic syndrome endocrinologist as well as patient teaching The goal of this study is to randomize patients with the metabolic syndrome who are admitted to the hospital for heart failure to this clinic collaborative care versus the usual doctor appointments usual care The purpose of this study is to see if collaborative care is better medical care than usual care Specifically we will see if patients in collaborative care will have
1 fewer admissions to hospitals for illness
2 better blood pressure sugar fat and heart failure control
3 better patient satisfaction and knowledge about their diseases
4 lower levels of inflammation
1 fewer admissions to hospitals for illness
2 better blood pressure sugar fat and heart failure control
3 better patient satisfaction and knowledge about their diseases
4 lower levels of inflammation
Detailed Description:
A striking feature of the Harris County Hospital District heart failure population is that the prevalence of obesity 508 and the metabolic syndrome 489 exceeds that of the general US population The metabolic syndrome is defined as the presence of 3 out of 5 components abdominal obesity elevated blood pressure dyslipidemias triglycerides and high density lipoprotein and insulin resistance and hyperglycemia Current treatment recommendations for the metabolic syndrome include lifestyle modification diet exercise and weight control and targeted pharmaceutical therapy for the individual components Although specialized care for the metabolic syndrome has not been reported separately both specialty heart failure care and endocrinology care have been shown to reduce hospital admissions and health care costs increase target medication titration and disease control improve quality of life and survival in patients with heart failure and diabetes respectively As both heart failure and the metabolic syndrome are commonly found in the same patients collaborative out-patient management of both conditions in the same clinic is novel and may have a significant impact on outcomes
Hypothesis
Compared to usual post-discharge follow-up collaborative treatment of heart failure patients with the metabolic syndrome by a team composed of an endocrinologist cardiologist patient educator nurse and case manager will result in
Decreased hospital readmissions and emergency room visits
Health care cost savings
Increased achievement of treatment goals target blood pressure HgbA1c lipids and heart failure medication titration
Improved patient satisfaction knowledge and compliance
Lower levels of markers of inflammation and insulin resistance
Hypothesis
Compared to usual post-discharge follow-up collaborative treatment of heart failure patients with the metabolic syndrome by a team composed of an endocrinologist cardiologist patient educator nurse and case manager will result in
Decreased hospital readmissions and emergency room visits
Health care cost savings
Increased achievement of treatment goals target blood pressure HgbA1c lipids and heart failure medication titration
Improved patient satisfaction knowledge and compliance
Lower levels of markers of inflammation and insulin resistance
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