Smoking CessationNCT04114526
Durham Housing Authority (DHA) Community Health Advisor (CHA) Smoking Cessation Project
A study testing Nicotine Replacement Therapy in people with Smoking Cessation, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine Replacement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2019to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- less than18 years of
- cognitive impairment
- planning to move from the property in the next 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collaboration to Develop and Pilot Test a Community Health Advisor Smoking Cessation Program for Durham Public Housing Residents
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.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine Replacement Therapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Advisor 4-step Program | Experimental | Not described Receives: Other: Nicotine Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people who enroll in the study as measured by enrollment log.
Measured: 4 months
Number of people that interact with community health advisors
Measured: 5 months
Number of participants who rate the intervention as helpful for quitting based on survey questionnaire.
Measured: 5 months
Change in number of cigarettes smoked per day as measured by questionnaire
Measured: Baseline and day 28
Change in smoking cessation motivation will be self-reported on a 7-point scale.
1=not at all motivated and 7=completely motivated.
Measured: Baseline and day 28
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".
Measured: Baseline and day 28
Frequency of interaction with community health advisors during intervention period will be calculated from self-reports.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start19 Jul 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura J Fish, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114526
- Sponsor's protocol ID
- Pro00100099
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2019
- Last updated
- 12 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary outcomes will be available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaboration to Develop and Pilot Test a Community Health Advisor Smoking Cessation Program for Durham Public Housing Residents
- ClinicalTrials.gov ID
- NCT04114526
- Acronym / sponsor ID
- Pro00100099
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community Health Advisor 4-step Program | Experimental | Other: Nicotine Replacement Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (3 listed)
- less than18 years of
- cognitive impairment
- planning to move from the property in the next 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement TherapyCHAs 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. | Other | Community Health Advisor 4-step Program |
Primary outcome
Number of people who enroll in the study as measured by enrollment log.
Time frame: 4 months
Number of people that interact with community health advisors
Time frame: 5 months
Number of participants who rate the intervention as helpful for quitting based on survey questionnaire.
Time frame: 5 months
Change in number of cigarettes smoked per day as measured by questionnaire
Time frame: Baseline and day 28
Change in smoking cessation motivation will be self-reported on a 7-point scale.
Time frame: Baseline and day 28
1=not at all motivated and 7=completely motivated.
Change in smoking status as measured by self-reports.
Time frame: Baseline and day 28
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".
Frequency of interaction with community health advisors during intervention period will be calculated from self-reports.
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary outcomes will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura J Fish, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement Therapy in people with Smoking Cessation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of people who enroll in the study as measured by enrollment log. (time frame: 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.