Smartphone-delivered Automated Video-assisted Smoking Treatment for Patrons of a Food Resource Center (AVAST-FRC)

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Counseling; Other: Smartphone-delivered automated treatment; Behavioral: Self-help materials; Drug: nicotine patch

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Tobacco Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >/= 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Treatment; Participants 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.	Behavioral: Counseling; Proactive phone counseling with a Certified Tobacco Treatment Counselor; Behavioral: Self-help materials; Self-help smoking cessation materials.; Drug: nicotine patch; 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.
Experimental: Automated Treatment; Participants 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.	Other: Smartphone-delivered automated treatment; Tailored video clips, text and graphical messages delivered automatically each week to the participant.; Behavioral: Self-help materials; Self-help smoking cessation materials.; Drug: nicotine patch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Status	Biochemically verifying smoking status on all participants by collecting an expired carbon monoxide breath sample.	3-Month Follow-Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dropout rate	The investigators will assess the number of participants who dropped out of the study.	3-Month Follow-Up
Intervention delivery rate	The investigators will assess the number of sessions completed by participants.	3-Month Follow-Up
Participant satisfaction with treatment	The investigators will use the Client Satisfaction Questionnaire to evaluate participant satisfaction.	3-Month Follow-Up

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Damon Vidrine, DrPH, OUHSC

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): May 19, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: smoking cessation, food pantry
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 7277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No