Impact of Patient-Centered Approach for Communicating Coronary Calcium on Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Patient Self-Reported Smoking Habits and Cessation
研究概览
简要总结
This multicenter clustered randomized prospective study will be managed by the American College of Radiology Center for Research and Innovation (ACR CRI). The research team aims to test the efficacy of a patient-centered educational intervention based on coronary artery calcification (CAC) information in cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.
详细描述
Objectives:
The overall goal of the proposed study is to improve cardiovascular health of smokers and previous smokers, as CAD is the most common cause of death in this population. Patients enrolled in lung cancer screening programs compose a highly suitable cohort of heavy smokers and previous smokers with 55-80 years of age for testing interventions that could improve the cardiovascular health of the population
The objective is to use coronary artery calcification burden, derived from computed tomography studies obtained for lung cancer screening purposes, to motivate patients into improving their health habits. The specific goal of this study is to test the efficacy of a patient-centered educational intervention based on CAC information in appropriate statin use and cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.
Recruitment:
Patients will be sent a mail or email research packet containing the invitation to join the study, the consent form and the baseline survey. Alternatively, patients could receive a phone call regarding information about the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 to 80 years old
- •More than 20 pack years of smoking
- •Actively smoking or previous smokers who quit with the last 15 years
- •Completed a Low-dose CT Scan for Lung Cancer Screening within 30 day of registration
排除标准
- •Patients unable to understand the informed consent process
- •Patients without a contact phone number or permanent address to receive the study intervention.
- •Patients who do not understand the English language
- •Patients with known CAD or prior heart surgery /intervention
结局指标
主要结局
Patient Self-Reported Smoking Habits and Cessation
时间窗: 6 Months
Patients' self-reported smoking habits will be assessed via phone call or questionnaire at baseline and 6-month follow-up.
Guideline-Appropriate High Cholesterol Care
时间窗: 6 Months
Rate of statin use (how often patients are required to take statin medications) and adherence (how often patents comply with taking statin medications as prescribed) to prescription in patients with known hypercholesterolemia. This will be determined by patients' self-reported answers to questions during interviews and review of medical records. Both rate of statin use and patient compliance will be used to generate a single, overall assessment of how well patients are being treated for and managing their hypercholesteremia.
Exercise Level
时间窗: 6 Months
Changes in exercise level, surveyed using International Physical Activity Questionnaire (IPAQ-short) questionnaire. The IPAQ-short questionnaire is comprised of 7, self-reported, open-ended questions surrounding individuals' last 7-day recall of physical activity. The questionnaire estimates the total physical activity in Metabolic Equivalent of Task (METs)- min/week and time spent sitting. Scores vary depending on the person's activity level throughout the preceding 7 days, and there is not defined range for scores, as the questions are open ended (e.g. How many hours did you spend doing vigorous activities during the last 7days?).
Weight loss
时间窗: 6 Months
Patient reported weight changes
Blood Pressure Control
时间窗: 6 Months
Patient reported blood pressure changes and initiation of anti-hypertensive therapy. Both systolic/diastolic blood pressure will be measured.
Patient Anxiety
时间窗: 6 Months
Patient anxiety, measured by changes in Generalize Anxiety Disorder-7 (GAD-7) anxiety questionnaire 6 months after intervention. The GAD-7 questionnaire is rated on a scale from 0-21, with higher scores indicating higher patient self-reported anxiety levels.
Number of Invasive/Noninvasive Hospitalizations
时间窗: 6 Months
Clinical visits, cardiac imaging tests, and hospitalizations 6 months after the intervention, to be measured by medical record review (to be assessed by research coordinator at 6 month follow-up) and follow up phone survey (patient self-reporting). Number of visits, obtained from both the patient interview and patient medical records, for both invasive and noninvasive hospitalizations, will be combined to generate a single number, or complete total number of visits patients have experienced 6 months after intervention.
次要结局
未报告次要终点