Improving Health Behaviors Through Telephone Linked Care
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|ClinicalTrials.gov Identifier: NCT00314197|
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : September 26, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Diet Physical Activity Smoking Alcohol Abuse||Behavioral: Telephone Linked Care - Behavior Change Counseling System Behavioral: Telephone-linked behavioral counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care|
|Study Start Date :||April 2006|
|Actual Study Completion Date :||June 2007|
- 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 [ Time Frame: 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. [ Time Frame: baseline, 3, 6, and 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314197
|United States, Kansas|
|American Academy of Family Physicians National Research Network|
|Leawood, Kansas, United States, 66211-2672|
|Principal Investigator:||Wilson D Pace, MD, FAAFP||American Academy of Family Physicians National Research Network|