Evaluating a Telemedicine Smoking Cessation Program in Rural Primary Care Practices

Smoking Clinical Trial

Official title:

Telemedicine for Smoking Cessation in Rural Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843505
• Other study ID #: 625
• Secondary ID: R01HL087643-01A2
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2009
• Last updated: October 4, 2012
• Start date: June 2009
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

People who smoke cigarettes and live in rural areas may not have access to a wide variety of resources to help them stop smoking. This study will evaluate two smoking cessation programs—an Internet-based telemedicine program and a telephone-based quitline program—among rural residents.

Description:

People who live in rural areas are more likely to smoke cigarettes than people who live in urban and suburban areas. However, many smoking cessation resources and programs may not be available to residents of rural areas. Toll-free tobacco telephone quitlines are proven to help people stop smoking and are available to almost everyone living in the United States, but only 1% to 5% of smokers actually use them. Another option for helping people stop smoking may involve having doctors provide smoking cessation programs in their offices or clinics; however, most doctors' offices do not have the resources to provide this type of service. Telemedicine provides medical information over the phone or through the Internet by using various technologies, including Webcams or video conferencing equipment. It has been used successfully to provide psychiatric care and addictions counseling, but there have been no studies that have examined the effectiveness of a telemedicine smoking cessation program. The purpose of this study is to compare the effectiveness of a telemedicine smoking cessation program that takes place in a doctor's office versus the effectiveness of a traditional telephone quitline smoking cessation program among rural smokers.

The study will be conducted at 25 rural doctors' offices in Kansas. Participants will be randomly assigned to participate in a telephone quitline program or a telemedicine program. Participants in the telephone quitline program will receive four sessions of telephone quitline counseling from smoking cessation counselors over an 8-week period. Participants in the telemedicine program will receive four sessions of telemedicine counseling from smoking cessation counselors over an 8-week period, which will be delivered through two-way Webcams at computers in the doctors' offices. All participants will receive educational handouts and individually tailored quit plans, including information on smoking cessation medications. At baseline and Months 3, 6, and 12, all participants will take part in telephone interviews with study researchers to assess smoking habits. At baseline and Month 12, participants will mail a saliva sample to researchers for the purposes of determining the level of nicotine in the body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Smokes cigarettes every day

• Smokes five or more cigarettes per day

• Has smoked cigarettes for at least 1 year before study entry

• Has a home address and phone number

• Willing to participate in phone assessments

• Willing to be assigned to either of the two study programs

Exclusion Criteria:

• Pregnant or breastfeeding

• Another household member is enrolled in the study

• Moving out of the area of residence in the 14 months after study entry

• Primary care provider is not participating in the study

• Use of other forms of tobacco products (e.g., cigars, spit, snuff) in addition to cigarettes

• Use of a smoking cessation medication

Study Design

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Telemedicine Smoking Cessation Program
Participants will receive four sessions of telemedicine smoking cessation counseling over an 8-week period. The telemedicine sessions will be delivered by two-way Webcams mounted on desktop computers in the doctors' offices.
• Telephone Quitline Smoking Cessation Program
Participants will receive four sessions of smoking cessation counseling delivered by telephone in their homes over an 8-week period.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Kimber Richter, PhD, MPH, MA	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

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* Note: There are 156 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence		Measured at Months 3, 6, and 12	No
Secondary	Prolonged abstinence		Measured at Months 3, 6, and 12	No

External Links

•   Click here for the "Telemedicine: Past, Present, Future" article Web page.
•   Click here for the Bureau of Labor Statistics, U.S. Department of Labor Web site.
•   Click here for the Centers for Medicare & Medicaid Services Medlearn Matters: Smoking and Tobacco Use Cessation Counseling Web page.
•   Click here for the North American Quitline Consortium, part of the National Cancer Institute, "1-800-Quit Now" Data for U.S. States (Available to members or by e-mail request to: NAQC@americanlegacy.org)
•   Click here for the Pew Internet & American Life Project "Home Broadband Adoption 2006" Report Web page.
•   Click here for the Telecommunications Service in Rural America Web page on the Federal Communications Commission Web site.
•   Click here for the United States Department of Agriculture Economic Research Service, State Fact Sheet for Kansas Web page.