search
Back to results

Improving Health Behaviors Through Telephone Linked Care

Primary Purpose

Diet, Physical Activity, Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone Linked Care - Behavior Change Counseling System
Telephone-linked behavioral counseling
Sponsored by
American Academy of Family Physicians
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diet focused on measuring automated counseling system, telephone-based intervention, behavior change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • American Academy of Family Physicians National Research Network

Outcomes

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
At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2006
Last Updated
September 24, 2007
Sponsor
American Academy of Family Physicians
Collaborators
Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
search

1. Study Identification

Unique Protocol Identification Number
NCT00314197
Brief Title
Improving Health Behaviors Through Telephone Linked Care
Official Title
Study That Examines Integration of the Telephone Linked Care Behavioral Change (Automated Counseling) System Into Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: successfully integrate an automated telephone behavior change intervention into primary care practices; 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Physical Activity, Smoking, Alcohol Abuse
Keywords
automated counseling system, telephone-based intervention, behavior change

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Telephone Linked Care - Behavior Change Counseling System
Intervention Type
Behavioral
Intervention Name(s)
Telephone-linked behavioral counseling
Primary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilson D Pace, MD, FAAFP
Organizational Affiliation
American Academy of Family Physicians National Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Academy of Family Physicians National Research Network
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211-2672
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Improving Health Behaviors Through Telephone Linked Care

We'll reach out to this number within 24 hrs