Support Person Intervention to Promote a Smoking Helpline

NCT ID: NCT01331226

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1020 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-04-30

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).

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

Tobacco Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3 session telephone counseling

Group Type: EXPERIMENTAL

telephone counseling 3 sessions

Intervention Type: BEHAVIORAL

3 sessions of telephone counseling

1 session telephone counseling

Group Type: EXPERIMENTAL

telephone counseling 1 session

Intervention Type: BEHAVIORAL

1 session of telephone counseling

written materials

Group Type: ACTIVE_COMPARATOR

written materials only

Intervention Type: BEHAVIORAL

written materials only

Interventions

telephone counseling 3 sessions

3 sessions of telephone counseling

Intervention Type: BEHAVIORAL

telephone counseling 1 session

1 session of telephone counseling

Intervention Type: BEHAVIORAL

written materials only

written materials only

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Christi Patten

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mayo CLinic

Rochester, Minnesota, United States

Countries

United States

References

Patten CA, Boyle R, Tinkelman D, Brockman TA, Lukowski A, Decker PA, D'Silva J, Lichtenstein E, Zhu SH. Linking smokers to a quitline: randomized controlled effectiveness trial of a support person intervention that targets non-smokers. Health Educ Res. 2017 Aug 1;32(4):318-331. doi: 10.1093/her/cyx050.

Reference Type: DERIVED

PMID: 28854569 (View on PubMed)

Other Identifiers

10-008318

Identifier Type: OTHER

Identifier Source: secondary_id

11-001796

Identifier Type: -

Identifier Source: org_study_id