Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity and smoking in the intervention group compared to patients in the control group
研究概览
简要总结
The investigators propose to conduct a randomized controlled trial at the patient level of the Telephone Linked Care - Behavioral Change (TLC-BC) system, which is designed to promote smoking cessation, reduce risky drinking, and improve physical activity and diet. They expect to:
- successfully integrate an automated telephone behavior change intervention into primary care practices;
- demonstrate improvement in health behaviors for individuals randomized (assigned by systematic chance) to use the TLC-BC system compared to individuals who receive written health education informational packets; and
- evaluate the direct costs associated with the use and operation of the TLC-BC system.
Project aims and hypotheses follow:
Aim 1: Integrate a proven, totally automated computer telephone intervention, Telephone Linked Care - Behavior Change (TLC-BC), into primary care practices. This will be assessed by the patient and clinician/staff surveys at the end of data collection.
Aim 2: Demonstrate an improvement in health behaviors for individuals randomized to use the TLC-BC system compared to individuals who receive written informational packets.
Aim 3: Evaluate the direct costs associated with the use and operation of the TLC-BC system within the primary care setting.
Hypothesis 1: The Telephone Linked Care - Behavioral Change system will be successfully implemented by patients and practices.
Hypothesis 2: At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity, and smoking in the intervention group compared to patients in the control group.
Hypothesis 3: At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
详细描述
See above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Capable of giving informed consent
- •Reliable access to a phone
- •Able to read English
排除标准
- •Less than 18 years of age
- •Not capable of giving informed consent
- •No reliable access to a phone
- •Unable to read English (including blindness)
- •Too ill to participate
- •Not willing to allow the Telephone Linked Care - Behavior Change system to provide health information reports based on responses to physician
结局指标
主要结局
At 6 months a clinically significant improvement in behavioral change rates will be demonstrated for diet, physical activity and smoking in the intervention group compared to patients in the control group
时间窗: 6 months
At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
时间窗: baseline, 3, 6, and 9 months
次要结局
未报告次要终点
