Improving Health Behaviors Through Telephone Linked Care

Study Overview
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Brief Summary
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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.

Detailed Description
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See above

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

Conditions
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Diet, Physical Activity, Smoking, Alcohol Abuse

Intervention / Treatment
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* Behavioral: Telephone Linked Care - Behavior Change Counseling System
* Behavioral: Telephone-linked behavioral counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Capable of giving informed consent Reliable access to a phone Able to read English Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Telephone Linked Care - Behavior Change Counseling System|nan|
|Behavioral: Telephone-linked behavioral counseling|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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. |  | baseline, 3, 6, and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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automated counseling system, telephone-based intervention, behavior change