Improving Health Behaviors Through Telephone Linked Care

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314197
• Other study ID #: 06-005
• Status: Completed
• Phase: N/A
• First received: April 11, 2006
• Last updated: September 24, 2007
• Start date: April 2006
• Est. completion date: June 2007

Study information

• Verified date: September 2007
• Source: American Academy of Family Physicians
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Diet
• Physical Activity
• Smoking

Intervention

Behavioral:
• Telephone Linked Care - Behavior Change Counseling System

• Telephone-linked behavioral counseling

Locations

Country	Name	City	State
United States	American Academy of Family Physicians National Research Network	Leawood	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
American Academy of Family Physicians	Agency for Healthcare Research and Quality (AHRQ), Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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