Tobacco Cessation Clinical Trial
— ClearWay #4Official title:
Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline
Verified date | April 2015 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This study is designed to examine if a telephone-based intervention delivered to a support person (i.e., friend, spouse of a smoker) increases the smoker's use of the Minnesota helpline. In addition, the study will examine if the rate of smoker calls to the helpline is greater if the support person receives 3 intervention calls, 1 intervention call, or no calls (written materials only, control condition).
Status | Completed |
Enrollment | 1020 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The support person must 1. reside in Minnesota 2. be 18 years of age or older 3. provide written informed consent 4. be a never or former cigarette smoker (no cigarette smoking in the past 6 months) 5. want to support a current cigarette smoker (has smoked a total of >1 cigarettes during the past 7 days) who is 18 years of age or older, resides in Minnesota, and has not been enrolled in a helpline or any other cessation program in the last 3 months 6. be able and willing to participate in all aspects of the study 7. have access to a working telephone 8. have current and anticipated contact (any combination of face-to-face, telephone, text messaging, or electronic mail) with the smoker on at least 3 days a week for the 30 week study duration. Exclusion Criteria: - Support persons will be excluded if another support person from the same household has enrolled. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo CLinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | helpline utilization | smoker calls to the helpline | At 7 month follow-up | No |
Secondary | smoker quit attempts and cessation | 7 month follow-up | No |
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