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Support Person Intervention to Promote a Smoking Helpline (ClearWay #4)

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ClinicalTrials.gov Identifier: NCT01331226
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Christi Patten, Mayo Clinic

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Tobacco Cessation Behavioral: telephone counseling 3 sessions Behavioral: telephone counseling 1 session Behavioral: written materials only Not Applicable

Detailed Description:

We will conduct a randomized clinical trial within the ongoing service of the QUITPLAN® Helpline. Our primary aim is to examine the efficacy of two levels of telephone counseling for support persons (1 or 3 sessions) compared with a control condition on the proportion of smokers who call the Helpline over the 7 month follow-up period. We hypothesize a dose response relationship between number of telephone sessions provided to the support persons and smoker calls to the Helpline. Additional aims are to examine smoker quit attempts and cessation, and cost-effectiveness of the interventions.

Nonsmoking adult support persons (N=1020) residing in Minnesota will be enrolled and randomly assigned to one of three study conditions: (1) control condition -written self-help materials, (2) written materials plus one telephone session, or (3) written materials plus three telephone sessions. Outcome assessments will be completed by support persons and smokers at post-treatment (week 4) and at 7 month follow-up.

This design will allow for evaluation of whether results from our previous trial (Patten et al., in press, AJPM) can be replicated when the intervention is implemented within a "real-world" setting. That is all support person intervention calls will be delivered by the Helpline. Moreover, we will examine the potential efficacy and cost-effectiveness of a streamlined version of the intervention (i.e., 1 call). Furthermore, the proposed study will provide new data on quit attempts and cessation among the smokers. Ultimately, positive findings from this line of research could serve as the basis for expanding the range of helpline services to nonsmokers.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline
Study Start Date : July 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: 3 session telephone counseling Behavioral: telephone counseling 3 sessions
3 sessions of telephone counseling

Experimental: 1 session telephone counseling Behavioral: telephone counseling 1 session
1 session of telephone counseling

Active Comparator: written materials Behavioral: written materials only
written materials only




Primary Outcome Measures :
  1. helpline utilization [ Time Frame: At 7 month follow-up ]
    smoker calls to the helpline


Secondary Outcome Measures :
  1. smoker quit attempts and cessation [ Time Frame: 7 month follow-up ]


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:   Yes
Criteria

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.

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): NCT01331226


Locations
United States, Minnesota
Mayo CLinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christi Patten, Professor of Psychology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01331226     History of Changes
Other Study ID Numbers: 11-001796
10-008318 ( Other Identifier: Mayo Clinic )
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015