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Smoking CessationPhase 4AVAST-FRCNCT03060278

Smartphone-delivered Automated Video-assisted Smoking Treatment for Patrons of a Food Resource Center

A Phase 4 study testing Self-help materials, nicotine patch and Smartphone-delivered automated treatment in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed pilot study seeks to address the smoking cessation treatment needs of underserved smokers with limited resources by evaluating the feasibility and preliminary efficacy of a smartphone delivered automated video-assisted smoking treatment (AVAST). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Smoking Cessation
What is being tested?
Self-help materials, nicotine patch and Smartphone-delivered automated treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
15 May 2017to 31 Dec 2017
Phase
Phase 4
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >/= 18 years
  • Smoked >/= 100 cigarettes in a lifetime
  • English speaking
  • Currently smoking 5 or more cigarettes per day
  • Willing to make a quit attempt within 1 week of enrollment
  • Patron of the Urban Mission Food Resource Center

Who cannot join

  • History of medical condition that precludes the use of nicotine replacement therapy
  • Current use of smoking cessation medications
  • Pregnant or nursing
  • Enrolled in another smoking cessation study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oklahoma Tobacco Research Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Smartphone-delivered Automated Video-assisted Smoking Treatment for Patrons of a Food Resource Center: Project AVAST - FRC

The proposed pilot study seeks to address the smoking cessation treatment needs of underserved smokers with limited resources by evaluating the feasibility and preliminary efficacy of a smartphone delivered automated video-assisted smoking treatment (AVAST). AVAST will enable smoking cessation treatment content to be presented with voice/audio, images, videos, and text in an interactive, structured format anytime and anywhere. Participants will be recruited from the Urban Mission, a non-profit food and resource center that serves approximately 20,000 people each year in the Oklahoma City metro area.

Read the detailed description

Smoking remains the leading cause of preventable morbidity and mortality in the United States,1-3 with tobacco use accounting for more deaths each year than the combined deaths attributable to alcohol, other drugs, homicide, suicide, motor vehicle accidents, and sexual behavior.4 While smoking cessation decreases the risk of lung cancer, other cancers, heart attack, stroke, and chronic lung disease,5 smoking quit rates are low. Approximately 40-50% of adult daily smokers make a quit attempt each year, but less than 14% of those smokers are able to maintain abstinence for even a single month.6 Individuals with low socioeconomic status are far more likely to smoke and are less successful at quitting.7-9 Thus, smoking is a critically significant behavioral risk factor that contributes to social disparities in the incidence and mortality of disease.10-15 Data indicate that smokers with higher socioeconomic status are more likely than those with lower socioeconomic status to use effective resources for quitting smoking, which appears to partially explain their higher cessation rates.16 Therefore, efficiently connecting underserved smokers with limited resources to efficacious tobacco cessation programs that are easily accessible is crucial for disease prevention and the elimination of health disparities.

Food security is defined by the United States Department of Agriculture (USDA) as having consistent, dependable access to enough food for all household members to lead an active, healthy life.17 In 2014, 14% of US households were classified as food insecure,17 a condition that describes limited or uncertain access to nutritionally adequate, personally acceptable, and safe foods.18 National studies indicate food insecurity within low-income households is associated with hypertension (24.6%), self-reported hyperlipidemia (43.3%), diabetes (10.2%), and smoking (35%).19 Emerging data suggests populations accessing foods at food pantries fare worse compared to the general low income, food insecure population, with self-reported hypertension (65.4%) and diabetes (25.9%) being notably higher.20

Participants (n=20) will be randomized to one of two treatment conditions: 1) Standard Treatment (ST; n=10) or Automated Treatment (AT; n=10). In the ST condition, research staff will provide participants with in- person brief advice to quit and enroll them in a proactive telephone counseling program for smoking cessation. This ST approach mirrors the Ask Advise Connect (AAC) approach that our team has previously developed and implemented in numerous clinic settings.21,22 ST will be evaluated against AT, the fully automated AVAST approach. In the AT condition, smokers will be provided with brief in-person advice to quit and be enrolled in a fully automated and interactive smartphone-based treatment program that comprises interactive text messaging, images and audio/video clips. Participants in both treatment conditions will be provided with nicotine replacement therapy (NRT) in the form of transdermal patches. The goal of this pilot project is to establish the preliminary efficacy and feasibility of AT. Data collected in the pilot will then be used to support the submission of a NIH R01 application (or equivalent), and to determine if AT performs no worse than the more resource intensive ST approach. If lack of inferiority is established in the larger project, the AT approach will be readily scalable; easily implemented by community-based clinics and organizations; and offer an efficient way to allocate limited public health resources to tobacco control interventions.

Being tested
Self-help materials, nicotine patch, Smartphone-delivered automated treatment, Counseling
Keywords
smoking cessation, food pantry
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-help materialsBehavioural

    Self-help smoking cessation materials.

  • nicotine patchDrug

    Participants who smoke >10 cigarettes per day will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg nicotine patches. Participants who smoke < 10 cigarettes per day will receive 6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches.

  • Smartphone-delivered automated treatmentOther

    Tailored video clips, text and graphical messages delivered automatically each week to the participant.

  • CounselingBehavioural

    Proactive phone counseling with a Certified Tobacco Treatment Counselor

Study groups in NCT03060278
Study groupRoleWhat they receive
Standard TreatmentActive comparatorParticipants randomized to Standard Treatment will receive a smartphone with active service, brief advice to quit smoking (self-help materials), an 8-week supply of nicotine replacement therapy (patches), and provided 5 proactive phone counseling sessions by a trained Certified Tobacco Treatment Specialist.
Receives: Behavioral: Self-help materials; Drug: nicotine patch; Behavioral: Counseling
Automated TreatmentExperimentalParticipants randomized to Automated Treatment will receive smartphone-delivered automated treatment that will provide tailored smoking cessation treatment by way of video clips, text and graphical messages. Participants will receive notifications on study provided smartphone once a week for an 8-week treatment period. Content delivered will be specific to the participants smoking status and motivation to quit.
Receives: Behavioral: Self-help materials; Drug: nicotine patch; Other: Smartphone-delivered automated treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking Status

    Biochemically verifying smoking status on all participants by collecting an expired carbon monoxide breath sample.

    Measured: 3-Month Follow-Up

Secondary outcomes (3)
  1. Participant satisfaction with treatment

    The investigators will use the Client Satisfaction Questionnaire to evaluate participant satisfaction.

    Measured: 3-Month Follow-Up

  2. Dropout rate

    The investigators will assess the number of participants who dropped out of the study.

    Measured: 3-Month Follow-Up

  3. Intervention delivery rate

    The investigators will assess the number of sessions completed by participants.

    Measured: 3-Month Follow-Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start15 May 2017
  3. Primary completion19 May 2017
  4. Study completion31 Dec 2017

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03060278
Sponsor's protocol ID
7277
Acronym
AVAST-FRC
Status last verified
Apr 2018
First submitted
10 Jan 2017
Last updated
12 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Self-help materials, nicotine patch and Smartphone-delivered automated treatment in people with Smoking Cessation, run by University of Oklahoma 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 6 inclusion and 4 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 Apr 2018. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Smoking Status (time frame: 3-Month Follow-Up). 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 Apr 2018.

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