Coronary Heart Disease Risk Clinical Trial
Official title:
GENErating Change, An Integrative Health Coaching and Genetic Risk Testing Pilot in Primary Care: A Multidisciplinary Approach to Personalized Medicine Targeting CHD Risk
Verified date | November 2014 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this 4 group (2x2) pilot randomized controlled trial is to test the feasibility and logistics of incorporating genetic risk information (9p21)into standard Coronary Heart Disease (CHD) risk counseling or health coaching intervention (or both) in primary care at 2 Duke Clinics.
Status | Completed |
Enrollment | 31 |
Est. completion date | October 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - age 18+, - presence of at least one of the following: - FPG > 100, - HbA1c > 5.7%, - diabetic, - LDL > 129, - triglycerides > 150, - total cholesterol > 200, - SBP > 130, - BMI > 25, - able to speak and understand English, - able and willing to give informed consent Exclusion Criteria: - diagnosed CHD (MI or documented coronary artery disease), - inability to ambulate or participate in physical activity, - serious chronic disease related complications, - current participation in a risk communication study for chronic disease, |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diet | National Cancer Institute (NCI) Multifactor Screener | 6 months | No |
Primary | Physical Activity | Stanford Brief Activity Scale (SBAS) | 6 months | No |
Secondary | Fasting blood glucose | 6 months | Yes | |
Secondary | Systolic blood pressure | 6 months | No | |
Secondary | Body mass index | 6 months | No | |
Secondary | Waist circumference | 6 months | No | |
Secondary | Low Density Cholesterol (LDL) | 6 months | No | |
Secondary | Triglyceride | 6 months | No | |
Secondary | Total cholesterol | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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Comparison of the Cost-Effectiveness of Coronary CT Angiography Versus Myocardial SPECT in Patients With Intermediate Risk of Coronary Heart Disease
|
N/A |