Improving Health Behaviors Through Telephone Linked Care

NCT ID: NCT00314197

Last Updated: 2007-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-06-30

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

Conditions

Diet; Physical Activity; Smoking; Alcohol Abuse

Keywords

automated counseling system; telephone-based intervention; behavior change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Telephone Linked Care - Behavior Change Counseling System

Intervention Type: BEHAVIORAL

Telephone-linked behavioral counseling

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

American Academy of Family Physicians

OTHER

Sponsor Role: lead

Principal Investigators

Wilson D Pace, MD, FAAFP

Role: PRINCIPAL_INVESTIGATOR

American Academy of Family Physicians National Research Network

Locations

American Academy of Family Physicians National Research Network

Leawood, Kansas, United States

Countries

United States

Other Identifiers

06-005

Identifier Type: -

Identifier Source: org_study_id