Clinical Trials Directory

Trials / Completed

CompletedNCT01331226

Support Person Intervention to Promote a Smoking Helpline

Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,020 (estimated)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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).

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALtelephone counseling 3 sessions3 sessions of telephone counseling
BEHAVIORALtelephone counseling 1 session1 session of telephone counseling
BEHAVIORALwritten materials onlywritten materials only

Timeline

Start date
2011-07-01
Primary completion
2015-04-01
Completion
2015-04-01
First posted
2011-04-07
Last updated
2015-04-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01331226. Inclusion in this directory is not an endorsement.