NCT02645838

Brief Summary

The purpose of this study is to determine whether or not motivational interviewing is effective in smoking cessation at general practice setting in China.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
unknown

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

December 24, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

December 24, 2015

Last Update Submit

January 3, 2016

Conditions

Smoking Cessation

Keywords

Motivational InterviewingSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • 1 week point prevalence abstinence (PPA)

    Validation: exhaled carbon monoxide (CO) (\< 10 ppm)

    Self-reported PPA at 1 week follow-up

Secondary Outcomes (3)

  • 1 month PPA

    Self-reported 7-day PPA at 1 month follow-up

  • 3 month PPA

    Self-reported 7-day PPA at 3 month follow-up

  • 6 month PPA

    Self-reported 7-day PPA at 6 month follow-up

Study Arms (2)

Motivational interviewing group

EXPERIMENTAL

1. Structural motivational interviewing for one section (about 20 mins)，provided by family physician 2. Follow-up telephone call，provided by family physician

Behavioral: Motivational interviewing

Brief advice group

NO INTERVENTION

Brief advice without motivational interviewing (about 5 mins), provided by family physician

Interventions

Motivational interviewingBEHAVIORAL

1\. Structural motivational interviewing for one section (about 20 mins)，provided by family physician;2. Follow-up telephone call，provided by family physician.

Motivational interviewing group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18 and 80 years.
  • Any person who replies "Yes" when asked "Do you smoke?".
  • Agree to participate the trial and be followed for at least one year.

You may not qualify if:

  • With severe mental illness, serious drug dependent patients.
  • Cannot understand conversation or cannot communicate, such as deafness or dementia.
  • Cannot be followed up for one year, such as not likely survive for more than one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Bock BC, Papandonatos GD, de Dios MA, Abrams DB, Azam MM, Fagan M, Sweeney PJ, Stein MD, Niaura R. Tobacco cessation among low-income smokers: motivational enhancement and nicotine patch treatment. Nicotine Tob Res. 2014 Apr;16(4):413-22. doi: 10.1093/ntr/ntt166. Epub 2013 Oct 30.

    PMID: 24174612BACKGROUND

  • Borrelli B, Novak S, Hecht J, Emmons K, Papandonatos G, Abrams D. Home health care nurses as a new channel for smoking cessation treatment: outcomes from project CARES (Community-nurse Assisted Research and Education on Smoking). Prev Med. 2005 Nov-Dec;41(5-6):815-21. doi: 10.1016/j.ypmed.2005.08.004. Epub 2005 Sep 22.

    PMID: 16182355BACKGROUND

  • Davis MF, Shapiro D, Windsor R, Whalen P, Rhode R, Miller HS, Sechrest L. Motivational interviewing versus prescriptive advice for smokers who are not ready to quit. Patient Educ Couns. 2011 Apr;83(1):129-33. doi: 10.1016/j.pec.2010.04.024.

    PMID: 20627440BACKGROUND

  • Glasgow RE, Whitlock EP, Eakin EG, Lichtenstein E. A brief smoking cessation intervention for women in low-income planned parenthood clinics. Am J Public Health. 2000 May;90(5):786-9. doi: 10.2105/ajph.90.5.786.

    PMID: 10800431BACKGROUND

  • Mantler T, Irwin JD, Morrow D. Motivational interviewing and smoking behaviors: a critical appraisal and literature review of selected cessation initiatives. Psychol Rep. 2012 Apr;110(2):445-60. doi: 10.2466/02.06.13.18.PR0.110.2.445-460.

    PMID: 22662398BACKGROUND

  • Miller RW, Rollnick S. Motivational Interviewing: Preparing people to change addictive behavior. New York: Guilford Press; 1991.

    BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yafang Huang, PHD

    School of General Practice and Continuing Education, Capital Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yafang Huang, PHD

CONTACT

+86-10-83911726huangyafang85@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PHD

Study Record Dates

First Submitted

December 24, 2015

First Posted

January 5, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

January 5, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

Individual patient data will be available.