Tobacco Cessation Clinical Trial
Official title:
Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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