Support Person Intervention to Promote a Smoking Helpline

Tobacco Cessation Clinical Trial

— ClearWay #4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331226
• Other study ID #: 11-001796
• Secondary ID: 10-008318
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: April 9, 2015
• Start date: July 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Cessation

Intervention

Behavioral:
• telephone counseling 3 sessions
3 sessions of telephone counseling
• telephone counseling 1 session
1 session of telephone counseling
• written materials only
written materials only

Locations

Country	Name	City	State
United States	Mayo CLinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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