Text Size

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

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Christi Patten, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01331226
First received: April 6, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Tobacco Cessation
 Behavioral: telephone counseling 3 sessions
Behavioral: telephone counseling 1 session
Behavioral: written materials only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • helpline utilization [ Time Frame: At 7 month follow-up ] [ Designated as safety issue: No ]
    smoker calls to the helpline


Secondary Outcome Measures:
  • smoker quit attempts and cessation [ Time Frame: 7 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 1020
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331226

Contacts
Contact: Christi A Patten, PhD 507-538-7370 patten.christi@mayo.edu
Contact: Christi M Smith 507-266-2658 smith.christina@mayo.edu

Locations
United States, Minnesota
Mayo CLinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Christi A Patten, PhD     507-538-7370     patten.christi@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Christi Patten, Professor of Psychology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01331226     History of Changes
Other Study ID Numbers: 11-001796, 10-008318
Study First Received: April 6, 2011
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 17, 2013