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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01414036 |
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Date of registration:
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09/08/2011 |
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Primary sponsor: |
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Public title:
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Pilot Study of Patient Navigation to Promote Smoking Cessation
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Scientific title:
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Primary Care-based Patient Navigation to Promote Smoking Cessation Treatment: a Pilot Randomized Controlled Trial |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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240 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01414036 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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Contacts
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Name:
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Karen E Lasser, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boston Medical Center/Boston University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. age > 18 years
2. smoked cigarettes in the past week
3. have a scheduled visit with a PCP
4. telephone access
5. English speaking
6. able and willing to participate in the study protocol and provide informed consent.
Exclusion Criteria:
1. planning to move out of the area within the next 6 months
2. cognitive impairments that preclude participation in study activities.
3. severe illness or distress
4. inability to read/understand English
5. actively using evidence-based smoking cessation treatment, and
6. transient residence or lack of a telephone for follow-up assessments.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cigarette Smoking
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Intervention(s)
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Behavioral: Patient navigation
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Other: Enhanced Traditional Care control
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Primary Outcome(s)
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engagement in smoking cessation treatment
[Time Frame: 3 months]
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Secondary Outcome(s)
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level of nicotine dependence
[Time Frame: 3 months]
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Stage of change with regard to smoking cessation
[Time Frame: 3 months]
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use of other tobacco treatment support
[Time Frame: 3 months]
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Use of tobacco treatment medications
[Time Frame: 3 months]
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Secondary ID(s)
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UL1RR025771
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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