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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04114526
Other study ID # Pro00100099
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 19, 2019
Est. completion date January 10, 2020

Study information

Verified date October 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent policy from the U.S. Department of Housing and Urban Development (HUD) mandates that all public housing units go smoke-free by August 2018. Residents in public housing units have little access to proven cessation interventions and support is imperative to increase quitting success and is currently lacking in these communities;' thus this mandate is causing stress without providing resources to quit. Using a Community Engaged Research (CEnR) approach, we propose to partner the Durham County Department of Public Health and the Durham Housing Authority to develop sustainable Community Health Advisor tobacco cessation program that can be implemented in public housing communities. To achieve this goal, we plan to build on our previous collaborations to 1) form a team of previously identified DHA residents who are activated to support smoking cessation among public housing residents who can serve as Community Health Advisors and deliver cessation interventions in DHA properties, and 2) co-develop and pilot test a Community Health Advisor smoking cessation program to promote linkages with cessation services and to provide cessation education to DHA residents. This collaboration builds on our previous work to understand barriers and identify solutions for supporting smoking cessation among DHA residents. We will work with Community Health Advisors to develop an intervention and conduct a pilot study with up to 30 participants, Our primary outcomes are feasibility and acceptability of the co-development cessation intervention. We will collect survey data for the pilot in REDCap. Potential risks of study participation include breach of confidentiality with regard to identifiable personal information and questions that might make participants feel uncomfortable.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date January 10, 2020
Est. primary completion date January 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- =18 years of age

- current smoker (smoked in the last seven days)

- planning on quitting in the next 6 months

- speak English

- currently living in DHA property

Exclusion Criteria:

- less than18 years of

- cognitive impairment

- planning to move from the property in the next 2 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nicotine Replacement Therapy
CHAs meet with all interested residents to discuss taking steps towards quitting. The CHAs follow a four step program with all participant 1) get to know the resident and their smoking, 2) Assess what the resident is ready to do to take steps towards quitting, 3) discuss using nicotine replacement therapy (NRT) in the form of patches, gum or lozenges, 4) set one goal for taking steps towards quitting. CHAs will attempt to follow up with participants after the initial encounter. There is no limit on the number of times the CHA may talk with the participants. Some follow interactions will be brief encounters in the neighborhood, while others will be at scheduled. All contacts with each participant will be tracked. We will provide up to 6 weeks of NRT patches, gum and lozenges to participants who are interested in using NRT to help them quit.

Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of people who enroll in the study as measured by enrollment log. 4 months
Primary Number of people that interact with community health advisors 5 months
Primary Number of participants who rate the intervention as helpful for quitting based on survey questionnaire. 5 months
Primary Change in number of cigarettes smoked per day as measured by questionnaire Baseline and day 28
Primary Change in smoking cessation motivation will be self-reported on a 7-point scale. 1=not at all motivated and 7=completely motivated. Baseline and day 28
Primary Change in smoking status as measured by self-reports. Participants will be asked on a questionnaire, "Have you smoked in the last 7 days even a puff" and will have the option of answering "yes" or "no". Baseline and day 28
Primary Frequency of interaction with community health advisors during intervention period will be calculated from self-reports. Day 28
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