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Completed

NCT Number: NCT00314197

Improving Health Behaviors Through Telephone Linked Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Academy of Family Physicians National Research Network

Leawood, Kansas, 66211-2672, United States

About this study

See above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone Linked Care - Behavior Change Counseling System

Behavioral

Telephone-linked behavioral counseling

Behavioral

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

American Academy of Family Physicians

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Apr 13, 2006
Registry last updated
Sep 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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