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Evaluating a Telemedicine Smoking Cessation Program in Rural Primary Care Practices
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Heart, Lung, and Blood Institute (NHLBI).   Recruitment status was  Recruiting

First Received on February 12, 2009.   Last Updated on August 21, 2009   History of Changes
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00843505
  Purpose

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.


Condition Intervention Phase
Smoking
 Behavioral: Telemedicine Smoking Cessation Program
Behavioral: Telephone Quitline Smoking Cessation Program
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telemedicine for Smoking Cessation in Rural Primary Care

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking
U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 7-day point prevalence abstinence [ Time Frame: Measured at Months 3, 6, and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prolonged abstinence [ Time Frame: Measured at Months 3, 6, and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 566
Study Start Date: June 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will take part in a telemedicine smoking cessation program.
 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.
Active Comparator: 2
Participants will take part in a telephone quitline smoking cessation program.
 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843505

Contacts
Contact: Kimber P. Richter, PhD, MPH, MA 913-588-2718 krichter@kumc.edu
Contact: Leah M Lambart, MPH 913-588-3782 llambart@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Kimber P. Richter, PhD, MPH, MA     913-588-2718     krichter@kumc.edu    
Contact: Leah M. Lambart, MPH     913-588-3782     llambart@kumc.edu    
Principal Investigator: Kimber P. Richter, PhD, MPH, MA            
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Kimber P. Richter, PhD, MPH, MA University of Kansas
  More Information

Additional Information:
Click here for the Pew Internet & American Life Project "Home Broadband Adoption 2006" Report Web page.  This link exits the ClinicalTrials.gov site
Click here for the Centers for Medicare & Medicaid Services Medlearn Matters: Smoking and Tobacco Use Cessation Counseling Web page.  This link exits the ClinicalTrials.gov site
Click here for the "Telemedicine: Past, Present, Future" article Web page.  This link exits the ClinicalTrials.gov site
Click here for the Bureau of Labor Statistics, U.S. Department of Labor Web site.  This link exits the ClinicalTrials.gov site
Click here for the Telecommunications Service in Rural America Web page on the Federal Communications Commission Web site.  This link exits the ClinicalTrials.gov site
Click here for the Telemedicine for the Medicare Population Evidence Report/Technology Assessment Web page.  This link exits the ClinicalTrials.gov site
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)  This link exits the ClinicalTrials.gov site
Click here for the Center for Tobacco Research and Intervention Fact Sheets Web site.  This link exits the ClinicalTrials.gov site
Click here for the United States Department of Agriculture Economic Research Service, State Fact Sheet for Kansas Web page.  This link exits the ClinicalTrials.gov site

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Responsible Party: Kimber Richter, PhD, MPH, MA, Associate Professor, Principal Investigator, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00843505     History of Changes
Other Study ID Numbers: 625, HL087643-01A2
Study First Received: February 12, 2009
Last Updated: August 21, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Smoking Cessation
Motivational Interviewing
Quitline
Telemedicine
Stop Smoking Medication

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on February 09, 2012



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