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
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

Additional relevant MeSH terms:
Smoking
Alcoholism
Habits
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014