Prevention Trial to Achieve Cardiovascular Targets

Obesity Clinical Trial

— IMPACT  

Official title:

Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642355
• Other study ID #: IMPACT-2012-400
• Status: Completed
• Phase: N/A
• First received: July 3, 2012
• Last updated: December 30, 2016
• Start date: June 2012
• Est. completion date: May 2016

Study information

• Verified date: December 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets) is to determine the best management strategy for patients undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. The study will compare different cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult, and (3) cardiovascular prevention consult with a behavioral intervention program over a 6-month period. The trial hypothesis is that for patients undergoing a cardiovascular intervention, a prevention consult and behavioral intervention is superior to usual care in reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin enrollment in the June of 2012.

Description:

SPECIFIC AIMS

Primary aim:

The primary aim is that a targeted Cardiovascular Prevention consult will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention.

Secondary aim:

The secondary aim is that a targeted Cardiovascular Prevention consult plus a behavioral intervention will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• at least 21 years of age or older

• Subjects scheduled to undergo a percutaneous coronary or peripheral vascular intervention

• Patients must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Life expectancy less than 1-year

• Inability to walk

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Myocardial Ischemia
• Obesity
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Prediabetes
• Prediabetic State

Intervention

Behavioral:
• Prevention Consult
In addition to usual care, patients will receive a prevention consult by a prevention fellow and attending following their intervention. The consult will include guideline based medical recommendations for optimization of the patient's medical regimen targeting dyslipidemia, hypertension and diabetes. In addition, each patient will be educated on the cardiovascular disease process and given detailed lifestyle recommendations on physical activity, improved nutrition, smoking cessation and medication adherence.
• Consult & Behavioral Intervention
In addition to usual care and prevention consult (as detailed above), patients will receive a full motivational intervention program by a trained motivational coach and text messages over 6 months.

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	The Rainer Arnhold Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gianos E, Schoenthaler A, Mushailov M, Fisher EA, Berger JS. Rationale and design of the Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets (IMPACT) trial. Am Heart J. 2015 Sep;170(3):430-7.e9. doi: 10.1016/j.ahj.2015.06.001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Non-HDL cholesterol		6 months	No
Secondary	Lipids	LDL-C, HDL, triglycerides	6 months	No
Secondary	Metabolic risk factors	weight, BMI, HbA1C, abdominal circumference	6 months	No
Secondary	Physical Activity	Yale Physical Activity assessment (Part 2)	6 months	No
Secondary	Nutrition	Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions	6 months	No
Secondary	Medication Adherence	Morisky-4 medication adherence survey	6 months	No
Secondary	Optimal medical regimen	assessment of lipid lowering and cardiovascular medication regimen	6 months	No
Secondary	Quality of life	Euro Qual 5D survey	6 months	No
Secondary	Smoking cessation	Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment	6 months	No
Secondary	Cardiovascular risk	cardiovascular risk assessment score (i.e. Framingham)	6 months	No
Secondary	Cardiovascular events	cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years	5 years	No

External Links

•   New York University Langone Center for the Prevention of Cardiovascular Disease website