Evaluating a Telemedicine Smoking Cessation Program in Rural Primary Care Practices
NCT ID: NCT00843505
Last Updated: 2012-10-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
566 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-06-30
Study Completion Date
2012-04-30
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.
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.
Conditions
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Smoking
Keywords
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Smoking Cessation
Motivational Interviewing
Quitline
Telemedicine
Stop Smoking Medication
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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1
Participants will take part in a telemedicine smoking cessation program.
Group Type
EXPERIMENTAL
Telemedicine Smoking Cessation Program
Intervention Type
BEHAVIORAL
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.
2
Participants will take part in a telephone quitline smoking cessation program.
Group Type
ACTIVE_COMPARATOR
Telephone Quitline Smoking Cessation Program
Intervention Type
BEHAVIORAL
Participants will receive four sessions of smoking cessation counseling delivered by telephone in their homes over an 8-week period.
Interventions
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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.
Intervention Type
BEHAVIORAL
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.
Intervention Type
BEHAVIORAL
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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
Kimber Richter, PhD, MPH, MA
OTHER
Sponsor Role
lead
Responsible Party
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Kimber Richter, PhD, MPH, MA
Associate Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Kimber P. Richter, PhD, MPH, MA
Role: PRINCIPAL_INVESTIGATOR
University of Kansas
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Site Status
Countries
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United States
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Mussulman L, Ellerbeck EF, Cupertino AP, Preacher KJ, Spaulding R, Catley D, Cox LS, Lambart L, Hunt JJ, Nazir N, Shireman T, Richter KP. Design and participant characteristics of a randomized-controlled trial of telemedicine for smoking cessation among rural smokers. Contemp Clin Trials. 2014 Jul;38(2):173-81. doi: 10.1016/j.cct.2014.04.008. Epub 2014 Apr 24.
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DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://www.nlm.nih.gov/archive/20040830/pubs/cbm/telembib.html
Click here for the "Telemedicine: Past, Present, Future" article Web page.
http://www.fcc.gov/cgb/rural
Click here for the Telecommunications Service in Rural America Web page on the Federal Communications Commission Web site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HL087643-01A2
Identifier Type: -
Identifier Source: secondary_id
625
Identifier Type: -
Identifier Source: org_study_id