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Evaluating a Telemedicine Smoking Cessation Program in Rural Primary Care Practices

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ClinicalTrials.gov Identifier: NCT00843505
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : October 5, 2012
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kimber Richter, PhD, MPH, MA, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Telemedicine Smoking Cessation Program Behavioral: Telephone Quitline Smoking Cessation Program Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telemedicine for Smoking Cessation in Rural Primary Care
Study Start Date : June 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 7-day point prevalence abstinence [ Time Frame: Measured at Months 3, 6, and 12 ]

Secondary Outcome Measures :
  1. Prolonged abstinence [ Time Frame: Measured at Months 3, 6, and 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843505

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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Kimber Richter, PhD, MPH, MA
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Kimber P. Richter, PhD, MPH, MA University of Kansas
Additional Information:
Richter KP, Surprenant ZJ, Schmelzle KH, Mayo MS. Detecting and documenting intimate partner violence: An intake form question is not enough. Violence Against Women. Vol 9; 2003:458-465.
Paine-Andrews A, Fawcett SB, Richter KP, Berkley JY, Williams EL, Lopez CM. Community coalition to prevent adolescent substance abuse: The case of the
Ellerbeck EF. Practice-level variance in ambulatory quality of care. J Gen Intern Med. April 2001 2001;16(supplement 1):192-193.
Engelman KK. Correlates of colorectal cancer screening among Medicare beneficiaries. The Gerontologist. 2000;40 (special issue 1):344
Spierto FW, Hannon WH, Kendrick JS, Bernert JT, Pirkle JL, Gargiullo P. Urinary cotinine levels in women enrolled in a smoking cessation study during and after pregnancy. J Smoking-Related Dis. 1988;5(2):65-76.
Hoyle RH, Kenny DA. Sample size, reliability, and tests of statistical mediation. In: Hoyle RH, ed. Statistical strategies for small sample research. Thousand Oaks, CA: Sage; 1999
Stone CA, Sobel ME. The robustness of estimates of total indirect effects in covariance structure models estimated by maximum likelihood. Psychometrika. 1990;55(337-52).
Kenny DA, Kashy DA, Bolger N. Data analysis in social psychology. In: Gilbert DT, Fiske ST, Lindzey G, eds. The Handbook of Social Psychology, Volume 1. New York: Oxford University Press; 1998:233-265
Glaser B, Strauss A. The Discovery of Grounded Theory: Strategies for Qualitative Research. Chicago: Aldine; 1967
Winer BJ. Statistical principles in experiemntal design. (2nd Edition): New York: McGraw-Hill; 1971
Brown RL. Assessing specific mediational effects in complex theoretical models. Structural Equation Modeling. 1997;4:142-156
Gold MR. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
Haddix AC, Teutsch SM, Corso PS. Prevention effectiveness: a guide to decision analysis and economic evaluation. 2nd ed. Oxford ; New York: Oxford University Press; 2003.
Miller WR, Rollnick S. Motivational interviewing: Preparing people to change addictive behavior. New York: Guilford Press; 1991.
American Medical Association. Physician Characteristics and Distribution in the US, 2007. Chicago, IL: American Medical Association; 2007.
Cupertino AP, Richter KP, Ellerbeck EF, Cox LS, Spaulding R. A Pilot study of telemedicine for smoking cessation Society for Research on Nicotine and Tobacco. Orlando - FL; 2006.
Doolittle GL, Spaulding A, Spaulding RJ. The financial side of a tele-oncology practice. In: Whitten P, Cook DJ, eds. Understanding Health Communication Technologies. San Francisco - CA: Jossey-Bass; 2004.
Nelson EL, Spaulding RJ. Adapting a patient-provider interaction coding system for interactive televideo. 2004;10:73.
Miller WR, Rollnick S. Motivational Interviewing: Preparing people for change. 2nd ed. ed. New York: Guilford Press; 2002.
Miller W. Combined Behavioral Intervention Manual: A Clinical Research Guide for Therapists Treating People with Alcohol Abuse and Dependence. DHHS Publication No. (NIH) 04-5288. Vol Volume 1. Bethesda, MD: DHHS Publication No. (NIH) 04-5288; 2004.
Bedrosian RC, Beck AT. Principles of cognitive therapy. In: Mahoney MH, ed. Psychotherapy Process: Current Issues and Future Directions. New York: Plenum; 1980:127-152.
Beck AT. Cognitive Therapy. In: Kaplan HI, Sadock BJ, eds. Comprehensive Textbook of Psychiatry. Vol II. New York: Williams and Wilkins; 1985:1432-1438.
Markland D, Ryan RM, Tobin VJ, Rollnick S. Motivational Interviewing and Self-Determination Theory. Journal of Social and Clinical Psychology. 2005;24(6):811-831.
Deci EL, Ryan RM. Handbook of self-determination research. Rochester, NY: University of Rochester Press; 2002.
Deci EL, Ryan RM. Intrinsic motivation and self-determination in human behavior. New York: Plenum; 1985.
Centers for Medicare & Medicaid Services. Medicare Benefit Policy Manual: Chapter 15 - Covered Medical and Other Health Services. Revision 37 ed: Centers for Medicare & Medicaid Services; 2005.
Fiore MC, Bailey WC, Cohen SJ, al. et. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.; 2000.
Kansas Department of Health and Environment. Primary Care: Health Professional Underserved Areas Report. Office of Local and Rural Health; 2004.
Eberhardt MS, Ingram DD, Makuc D. Urban and Rural Health Chartbook: Health United States, 2001. Hyattsville, MD: National Center for Health Statistics; 2001.
Bailey L. An Overview of NAQC. National Network of Tobacco Cessation Quitlines 2006 Regional Meeting -- Western Region. San Diego, CA; 2006.
Levin HM, McEwan PJ. Cost-effectiveness analysis: Methods and applications. 2nd ed. Thousand Oaks, Calif.: Sage Publications; 2001.
Moyers TB, Martin T, Manuel JK, Miller WR, Ernst D. Revised Global Scales: Motivational Interviewing Treatment Integrity (MITI) 3.0: University of New Mexico Center on Alcoholism, Substance Abuse and Addictions (CASAA); 2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kimber Richter, PhD, MPH, MA, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00843505    
Other Study ID Numbers: 625
R01HL087643-01A2 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012
Keywords provided by Kimber Richter, PhD, MPH, MA, University of Kansas Medical Center:
Smoking Cessation
Motivational Interviewing
Stop Smoking Medication