SmokingPhase 3NCT00843505
Evaluating a Telemedicine Smoking Cessation Program in Rural Primary Care Practices
A Phase 3 study testing Telemedicine Smoking Cessation Program and Telephone Quitline Smoking Cessation Program in people with Smoking, run by Kimber Richter, PhD, MPH, MA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Telemedicine Smoking Cessation Program and Telephone Quitline Smoking Cessation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Telemedicine for Smoking Cessation in Rural Primary Care
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Telemedicine Smoking Cessation Program, Telephone Quitline Smoking Cessation Program
- Keywords
- Smoking Cessation, Motivational Interviewing, Quitline, Telemedicine, Stop Smoking Medication
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine Smoking Cessation ProgramBehavioural
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.
Telephone Quitline Smoking Cessation ProgramBehavioural
Participants will receive four sessions of smoking cessation counseling delivered by telephone in their homes over an 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will take part in a telemedicine smoking cessation program. Receives: Behavioral: Telemedicine Smoking Cessation Program |
| 2 | Active comparator | Participants will take part in a telephone quitline smoking cessation program. Receives: Behavioral: Telephone Quitline Smoking Cessation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence
Measured: Measured at Months 3, 6, and 12
Secondary outcomes (1)
Prolonged abstinence
Measured: Measured at Months 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (158)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimber Richter, PhD, MPH, MA
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Kimber Richter, PhD, MPH, MA, University of Kansas Medical Center
- Investigators
- Kimber P. Richter, PhD, MPH, MA, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843505
- Sponsor's protocol ID
- 625
- Other IDs
- R01HL087643-01A2, HL087643-01A2
- Status last verified
- Oct 2012
- First submitted
- 12 Feb 2009
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Shireman TI, Tsevat J, Goldie SJ. Time costs associated with cervical cancer screening. Int J Technol Assess Health Care. 2001 Winter;17(1):146-52. doi: 10.1017/s0266462301104137.
PubMed 11329841Cupertino AP, Mahnken JD, Richter K, Cox LS, Casey G, Resnicow K, Ellerbeck EF. Long-term engagement in smoking cessation counseling among rural smokers. J Health Care Poor Underserved. 2007 Nov;18(4 Suppl):39-51. doi: 10.1353/hpu.2007.0117.
PubMed 18065851McGinnis JM, Foege WH. Actual causes of death in the United States. JAMA. 1993 Nov 10;270(18):2207-12.
PubMed 8411605Cronk CE, Sarvela PD. Alcohol, tobacco, and other drug use among rural/small town and urban youth: a secondary analysis of the monitoring the future data set. Am J Public Health. 1997 May;87(5):760-4. doi: 10.2105/ajph.87.5.760.
PubMed 9184502Doescher MP, Jackson JE, Jerant A, Gary Hart L. Prevalence and trends in smoking: a national rural study. J Rural Health. 2006 Spring;22(2):112-8. doi: 10.1111/j.1748-0361.2006.00018.x.
PubMed 16606421Stitzer ML. Combined behavioral and pharmacological treatments for smoking cessation. Nicotine Tob Res. 1999;1 Suppl 2:S181-7; discussion S207-10. doi: 10.1080/14622299050012041.
PubMed 11768178Hughes JR, Goldstein MG, Hurt RD, Shiffman S. Recent advances in the pharmacotherapy of smoking. JAMA. 1999 Jan 6;281(1):72-6. doi: 10.1001/jama.281.1.72.
PubMed 9892454Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2004;(3):CD000146. doi: 10.1002/14651858.CD000146.pub2.
PubMed 15266423Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47.
PubMed 16820546Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.
PubMed 16820548Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56.
PubMed 16820547Harris JM Jr. Disease management: new wine in new bottles? Ann Intern Med. 1996 May 1;124(9):838-42. doi: 10.7326/0003-4819-124-9-199605010-00009.
PubMed 8610954Ockene JK. Physician-delivered interventions for smoking cessation: strategies for increasing effectiveness. Prev Med. 1987 Sep;16(5):723-37. doi: 10.1016/0091-7435(87)90054-5.
PubMed 3317393Fagerstrom KO. Effects of nicotine chewing gum and follow-up appointments in physician-based smoking cessation. Prev Med. 1984 Sep;13(5):517-27. doi: 10.1016/0091-7435(84)90020-3.
PubMed 6396639Jamrozik K, Fowler G, Vessey M, Wald N. Placebo controlled trial of nicotine chewing gum in general practice. Br Med J (Clin Res Ed). 1984 Sep 29;289(6448):794-7. doi: 10.1136/bmj.289.6448.794.
PubMed 6434084
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for Smoking Cessation in Rural Primary Care
- ClinicalTrials.gov ID
- NCT00843505
- Acronym / sponsor ID
- 625
- Conditions
- Smoking
- Keywords
- Smoking Cessation, Motivational Interviewing, Quitline, Telemedicine, Stop Smoking Medication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Kimber Richter, PhD, MPH, MAUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Telemedicine Smoking Cessation ProgramParticipants will take part in a telemedicine smoking cessation program. |
| 2 | Active comparator | Behavioral: Telephone Quitline Smoking Cessation ProgramParticipants will take part in a telephone quitline smoking cessation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine Smoking Cessation ProgramParticipants 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. | Behavioural | 1 |
| Telephone Quitline Smoking Cessation ProgramParticipants will receive four sessions of smoking cessation counseling delivered by telephone in their homes over an 8-week period. | Behavioural | 2 |
Primary outcome
7-day point prevalence abstinence
Time frame: Measured at Months 3, 6, and 12
1 secondary outcome
Prolonged abstinence
Time frame: Measured at Months 3, 6, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
- Background: PubMed 11329841Shireman TI, Tsevat J, Goldie SJ. Time costs associated with cervical cancer screening. Int J Technol Assess Health Care. 2001 Winter;17(1):146-52. doi: 10.1017/s0266462301104137.
- Background: PubMed 18065851Cupertino AP, Mahnken JD, Richter K, Cox LS, Casey G, Resnicow K, Ellerbeck EF. Long-term engagement in smoking cessation counseling among rural smokers. J Health Care Poor Underserved. 2007 Nov;18(4 Suppl):39-51. doi: 10.1353/hpu.2007.0117.
- Background: PubMed 8411605McGinnis JM, Foege WH. Actual causes of death in the United States. JAMA. 1993 Nov 10;270(18):2207-12.
- Background: PubMed 9184502Cronk CE, Sarvela PD. Alcohol, tobacco, and other drug use among rural/small town and urban youth: a secondary analysis of the monitoring the future data set. Am J Public Health. 1997 May;87(5):760-4. doi: 10.2105/ajph.87.5.760.
- Background: PubMed 16606421Doescher MP, Jackson JE, Jerant A, Gary Hart L. Prevalence and trends in smoking: a national rural study. J Rural Health. 2006 Spring;22(2):112-8. doi: 10.1111/j.1748-0361.2006.00018.x.
- Background: PubMed 11768178Stitzer ML. Combined behavioral and pharmacological treatments for smoking cessation. Nicotine Tob Res. 1999;1 Suppl 2:S181-7; discussion S207-10. doi: 10.1080/14622299050012041.
- Background: PubMed 9892454Hughes JR, Goldstein MG, Hurt RD, Shiffman S. Recent advances in the pharmacotherapy of smoking. JAMA. 1999 Jan 6;281(1):72-6. doi: 10.1001/jama.281.1.72.
- Background: PubMed 15266423Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2004;(3):CD000146. doi: 10.1002/14651858.CD000146.pub2.
- Background: PubMed 16820546Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47.
- Background: PubMed 16820548Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.
- Background: PubMed 16820547Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56.
- Background: PubMed 8610954Harris JM Jr. Disease management: new wine in new bottles? Ann Intern Med. 1996 May 1;124(9):838-42. doi: 10.7326/0003-4819-124-9-199605010-00009.
- Click here for the "Telemedicine: Past, Present, Future" article Web page.Link provided by the sponsor.
- 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)Link provided by the sponsor.
- Click here for the United States Department of Agriculture Economic Research Service, State Fact Sheet for Kansas Web page.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimber P. Richter, PhD, MPH, MA principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telemedicine Smoking Cessation Program and Telephone Quitline Smoking Cessation Program in people with Smoking, run by Kimber Richter, PhD, MPH, MA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence (time frame: Measured at Months 3, 6, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00843505, which also lists 158 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.