Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291824
Status:
UNKNOWN
Last Update Posted:
2006-02-15
First Post:
2006-02-13
Brief Title:
Cardiovascular Lifestyle Study Effects and Expense of a Cardiovascular Risk Reduction Clinic in Primary Care
Sponsor:
Caroline Medical Group
Organization:
Caroline Medical Group
Study Overview
Official Title:
A Randomized Controlled Trial of the Effects and Expense of a Primary and Secondary Cardiovascular Risk Reduction Clinic in Primary Care
Status:
UNKNOWN
Status Verified Date:
2006-02
Last Known Status:
RECRUITING
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:
The purpose of this trial is to study the effects on risk reduction and expense of 3 approaches to the care of people with cardiovascular risk factors in a naturalistic primary care environment
Detailed Description:
Background Uncontrolled hypertension hyperlipidemia hyperglycemia smoking and other cardiovascular risks remain at epidemic proportions despite known efficacious treatments Issues of both provider and patient behavioral non-adherence to guidelines and therapeutic regimes respectively are key factors in non-control Few interventions aimed at reducing cardiovascular risk factors are based on sound theories of behavior change
Objective To assess the effectiveness and expense of three approaches to the care of persons with known risks for cardiovascular disease The three treatment approaches are usual care usual care plus nurse telephone calls and usual care plus clinic visits to a nurse andor physician
Design Patients will be randomized to a 1 specialized proactive and holistic cardiovascular risk management clinic using principles of behavior change 2 nurse telephone calls as an attention placebo yet a low dose health promotion intervention and 3 usual primary care A random sample of 670 patients with cardiovascular risks identified in the past five years will be selected Patients will be excluded if they do not speak English are cognitively impaired or live in a nursing home Interview questionnaires will measure cardiovascular risk intention to change social support depression coping and health services use In addition patients will be required to give a blood sample to measure cholesterol and glucose levels Patients will then be randomized to one of three treatment groups
Significance The expected findings of this study is that the cardiovascular clinic with nurse and physician will be most effective at reducing cardiovascular risk and will pay for itself by averting hospital and emergency use for cardiovascular events
Objective To assess the effectiveness and expense of three approaches to the care of persons with known risks for cardiovascular disease The three treatment approaches are usual care usual care plus nurse telephone calls and usual care plus clinic visits to a nurse andor physician
Design Patients will be randomized to a 1 specialized proactive and holistic cardiovascular risk management clinic using principles of behavior change 2 nurse telephone calls as an attention placebo yet a low dose health promotion intervention and 3 usual primary care A random sample of 670 patients with cardiovascular risks identified in the past five years will be selected Patients will be excluded if they do not speak English are cognitively impaired or live in a nursing home Interview questionnaires will measure cardiovascular risk intention to change social support depression coping and health services use In addition patients will be required to give a blood sample to measure cholesterol and glucose levels Patients will then be randomized to one of three treatment groups
Significance The expected findings of this study is that the cardiovascular clinic with nurse and physician will be most effective at reducing cardiovascular risk and will pay for itself by averting hospital and emergency use for cardiovascular events
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