NCT01311830

Brief Summary

This study will develop an intervention for adults who want to support a smoker. The goal of the intervention is for the support person to motivate \& encourage their smoker to call the state Quitline funded by Minnesota ClearWay. The study will examine the efficacy of a telephone based intervention for support persons compared to a self-help intervention (written materials only).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
534

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration 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

Study Start

First participant enrolled

September 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

2.6 years

First QC Date

March 8, 2011

Last Update Submit

March 22, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • proportion of smokers in each group who call the Minnesota Quitline, and changes in supportive behaviors among the support persons as measured by the Support Provided Measure.

    6 months

Secondary Outcomes (1)

  • quit attempts and changes in readiness to quit among the smokers

    6 months

Study Arms (2)

Telephone Counseling

ACTIVE COMPARATOR
Behavioral: Telephone Counseling

Written Materials

PLACEBO COMPARATOR
Behavioral: Written Materials

Interventions

Telephone Counseling
Written Materials

Eligibility Criteria

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

You may qualify if:

  • 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)
  • be interested in supporting a current cigarette smoker (has smoked a total of \>1 cigarettes during the past 7 days) who is 18 years of age or older and who resides in Minnesota
  • 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, or electronic mail) with the smoker on at least 3 days a week for the 26 week study duration.
  • Individuals 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, Smith CM, Brockman TA, Decker PA, Hughes CA, Nadeau AM, Sinicrope PS, Offord KP, Lichtenstein E, Zhu SH. Support-person promotion of a smoking quitline: a randomized controlled trial. Am J Prev Med. 2011 Jul;41(1):17-23. doi: 10.1016/j.amepre.2011.03.012.

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 10, 2011

Study Start

September 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations