Improving Health Behaviors Through Telephone Linked Care

This study has been completed.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Information provided by:
American Academy of Family Physicians
ClinicalTrials.gov Identifier:
NCT00314197
First received: April 11, 2006
Last updated: September 24, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention
Diet
Physical Activity
Smoking
Alcohol Abuse
Behavioral: Telephone Linked Care - Behavior Change Counseling System
Behavioral: Telephone-linked behavioral counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care

Resource links provided by NLM:


Further study details as provided by American Academy of Family Physicians:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Enrollment: 400
Study Start Date: April 2006
Study Completion Date: June 2007
Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314197

Locations
United States, Kansas
American Academy of Family Physicians National Research Network
Leawood, Kansas, United States, 66211-2672
Sponsors and Collaborators
American Academy of Family Physicians
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Wilson D Pace, MD, FAAFP American Academy of Family Physicians National Research Network
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00314197     History of Changes
Other Study ID Numbers: 06-005
Study First Received: April 11, 2006
Last Updated: September 24, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by American Academy of Family Physicians:
automated counseling system
telephone-based intervention
behavior change

ClinicalTrials.gov processed this record on September 18, 2014