Clinical trial NCT00314197: Improving Health Behaviors Through Telephone Linked Care
Official title: Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet
Physical Activity
Smoking
Alcohol Abuse
Keywords: automated counseling system
telephone-based intervention
behavior change
Lead sponsor: American Academy of Family Physicians
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2006-04-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: See above

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
measure: At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.
timeFrame: baseline, 3, 6, and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leawood
country: United States
facility: American Academy of Family Physicians National Research Network
state: Kansas
Study officials:
affiliation: American Academy of Family Physicians National Research Network
name: Wilson D Pace, MD, FAAFP
role: PRINCIPAL_INVESTIGATOR
References: