Clinical trial NCT00843505: Evaluating a Telemedicine Smoking Cessation Program in Rural Primary Care Practices
Official title: Telemedicine for Smoking Cessation in Rural Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Keywords: Smoking Cessation
Motivational Interviewing
Quitline
Telemedicine
Stop Smoking Medication
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-02-13
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 7-day point prevalence abstinence
timeFrame: Measured at Months 3, 6, and 12
Secondary outcomes:
measure: Prolonged abstinence
timeFrame: Measured at Months 3, 6, and 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas
name: Kimber P. Richter, PhD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
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