NCT03060278

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

4 days

First QC Date

January 10, 2017

Last Update Submit

April 10, 2018

Conditions

Smoking Cessation

Keywords

smoking cessation, food pantry

Outcome Measures

Primary Outcomes (1)

  • Smoking Status

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

    3-Month Follow-Up

Secondary Outcomes (3)

  • Participant satisfaction with treatment

    3-Month Follow-Up

  • Dropout rate

    3-Month Follow-Up

  • Intervention delivery rate

    3-Month Follow-Up

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

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: Self-help materialsDrug: nicotine patchBehavioral: Counseling

Automated Treatment

EXPERIMENTAL

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.

Behavioral: Self-help materialsDrug: nicotine patchOther: Smartphone-delivered automated treatment

Interventions

Self-help materialsBEHAVIORAL

Self-help smoking cessation materials.

Automated TreatmentStandard Treatment
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.

Automated TreatmentStandard Treatment
Smartphone-delivered automated treatmentOTHER

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

Automated Treatment
CounselingBEHAVIORAL

Proactive phone counseling with a Certified Tobacco Treatment Counselor

Standard Treatment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>/= 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation DevicesCounseling

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Damon Vidrine, DrPH

    OUHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

February 23, 2017

Study Start

May 15, 2017

Primary Completion

May 19, 2017

Study Completion

December 31, 2017

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)