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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01108432
Other study ID # 122286
Secondary ID U01DE016747
Status Completed
Phase Phase 0
First received April 20, 2010
Last updated January 24, 2013
Start date April 2010
Est. completion date June 2011

Study information

Verified date January 2013
Source Dental Practice-Based Research Network
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Our overall goal is to advance science related to using the Internet in health services delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed intervention is the first Internet-delivered intervention to target the dental microsystem for smoking cessation-providing access to hygienists and patients.


Description:

This study is designed to allow dental hygienists and dentists to provide additional tobacco cessation counseling with little additional marginal effort. This would be done using an Internet-based referral to external resources. This system, termed "ReferASmoker", will allow hygienists and dentists to refer patients to a patient education, self-management website, "Decide2Quit" and accompanying Quitline, while the patient is still in the dental office. We anticipate that hygienists will be the primary drivers of this intervention. Our intervention has several innovations designed to support the dental practice in their tobacco cessation activities and maximize patient cessation rates. We will randomize 80 community-based primary dental practices into a clinical trial.

Aim 1. To test hypothesis 1(H1)that the number of patients REFERRED to the self-management resource website will be larger in the intervention practices compared to control practices.

Aim 2. To test hypothesis 2 (H2) that the proportion of patients referred who GO to the patient self-management website will be larger in intervention practices compared to control practices

Aim 3. To test hypothesis 3 (H3) that the proportion of smokers who are referred who QUIT at six months will be larger among intervention compared to control because of the additional connectivity of the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Community-based practices with internet access available in the office seeing an average of five or more smokers in a week.

Exclusion Criteria:

- Exclude practices that have ongoing computer-based smoking cessation programs for patients.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Electronic Referral
Dental practices in this arm will be able to have option of making electronic patient referrals to the Decide2Quit website.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States Health Partners Research Foundation Minneapolis Minnesota

Sponsors (4)

Lead Sponsor Collaborator
Dental Practice-Based Research Network HealthPartners Institute, University of Alabama at Birmingham, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of smokers referred to tobacco cessation website We will asses the number of patient referrals that the dental hygienists make to the tobacco cessation website. 12 months No
Secondary Proportion of smokers who go to the tobacco cessation website We will assess the proportion of smokers who were referred to the tobacco cessation website to the number of patients who registered on the website. 12 months No
Secondary Point prevalence smoking cessation Tobacco cessation behaviors will be assessed by follow-up email and/or telephone interviews at six months from website enrollment. 6 months No
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