NCT01331226

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,020

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

3.8 years

First QC Date

April 6, 2011

Last Update Submit

April 9, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • helpline utilization

    smoker calls to the helpline

    At 7 month follow-up

Secondary Outcomes (1)

  • smoker quit attempts and cessation

    7 month follow-up

Study Arms (3)

3 session telephone counseling

EXPERIMENTAL
Behavioral: telephone counseling 3 sessions

1 session telephone counseling

EXPERIMENTAL
Behavioral: telephone counseling 1 session

written materials

ACTIVE COMPARATOR
Behavioral: written materials only

Interventions

3 sessions of telephone counseling

3 session telephone counseling

1 session of telephone counseling

1 session telephone counseling

written materials only

written materials

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The support person must
  • reside in Minnesota
  • be 18 years of age or older
  • provide written informed consent
  • be a never or former cigarette smoker (no cigarette smoking in the past 6 months)
  • 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
  • be able and willing to participate in all aspects of the study
  • have access to a working telephone
  • 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.

You may not qualify if:

  • Support persons will be excluded if another support person from the same household has enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo CLinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 7, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations