Evaluating a Telemedicine Smoking Cessation Program in Rural Primary Care Practices

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Telemedicine for Smoking Cessation in Rural Primary Care

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Telemedicine Smoking Cessation Program
* Behavioral: Telephone Quitline Smoking Cessation Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will take part in a telemedicine smoking cessation program. | Behavioral: Telemedicine Smoking Cessation Program<br>* 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.<br>|
| Active Comparator: 2<br>Participants will take part in a telephone quitline smoking cessation program. | Behavioral: Telephone Quitline Smoking Cessation Program<br>* Participants will receive four sessions of smoking cessation counseling delivered by telephone in their homes over an 8-week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence abstinence |  | Measured at Months 3, 6, and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged abstinence |  | Measured at Months 3, 6, and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Motivational Interviewing, Quitline, Telemedicine, Stop Smoking Medication