NCT00843505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

2.8 years

First QC Date

February 12, 2009

Last Update Submit

October 4, 2012

Conditions

Smoking

Keywords

Smoking CessationMotivational InterviewingQuitlineTelemedicineStop Smoking Medication

Outcome Measures

Primary Outcomes (1)

  • 7-day point prevalence abstinence

    Measured at Months 3, 6, and 12

Secondary Outcomes (1)

  • Prolonged abstinence

    Measured at Months 3, 6, and 12

Study Arms (2)

1

EXPERIMENTAL

Participants will take part in a telemedicine smoking cessation program.

Behavioral: Telemedicine Smoking Cessation Program

2

ACTIVE COMPARATOR

Participants will take part in a telephone quitline smoking cessation program.

Behavioral: Telephone Quitline Smoking Cessation Program

Interventions

Telemedicine Smoking Cessation ProgramBEHAVIORAL

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.

1
Telephone Quitline Smoking Cessation ProgramBEHAVIORAL

Participants will receive four sessions of smoking cessation counseling delivered by telephone in their homes over an 8-week period.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

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Related Links

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Kimber P. Richter, PhD, MPH, MA

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 5, 2012

Record last verified: 2012-10

Locations

US(1)