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临床试验/NCT00314197
NCT00314197已完成不适用

Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care

American Academy of Family Physicians2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2006年4月最近更新:
适应症

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:

  1. successfully integrate an automated telephone behavior change intervention into primary care practices;
  2. 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
  3. 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

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

研究者

申办方类型
Other

研究点 (2)

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