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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00314197
Other study ID # 06-005
Secondary ID
Status Completed
Phase N/A
First received April 11, 2006
Last updated September 24, 2007
Start date April 2006
Est. completion date June 2007

Study information

Verified date September 2007
Source American Academy of Family Physicians
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

See above


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Telephone Linked Care - Behavior Change Counseling System

Telephone-linked behavioral counseling


Locations

Country Name City State
United States American Academy of Family Physicians National Research Network Leawood Kansas

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Primary At baseline, 3, 6, and 9 months risky drinking will be identified, but there will be no difference in improvement between the study groups. baseline, 3, 6, and 9 months
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