Health TrialsbyHealthPanel

C-Raven, a Virtual Tobacco Cessation Intervention in Residency Clinics

ConditionTobacco Dependence
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorJohns Hopkins University

About this trial

In a residency clinic in Baltimore, the investigators propose to conduct a pilot RCT comparing a) an avatar-delivered computerized intervention (CI) for tobacco cessation augmented with CHW support and navigation to lung cancer screening to b) a waitlist control.

With a sample of participants from the residency clinic (N=30), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month, 3 months, and 6 months. The investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50 or older

Current tobacco use with >100 cigarettes smoked in the participant's lifetime

Considering smoking cessation

Planning to remain in local area for at least 6 months

Disqualifiers

Contraindication to nicotine replacement therapy

Current engagement in formal smoking cessation program

Major cognitive or psychiatric impairment

Severe hearing impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • C-Raven Virtual Tobacco Cessation Counseling

    Behavioral

    A two-module tobacco cessation intervention that involves interaction with a virtual counselor and includes instruction about addiction and the use of pharmacotherapy for cessation. Each module takes approximately 20 minutes to complete.

  • Nicotine Replacement Product

    Drug

    Participants will be offered up to a 12-week supply of nicotine patches and either nicotine gum or lozenges.

  • Community Health Worker

    Other intervention

    A community health worker will meet with each participant throughout the study period to teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation, conduct shared decision-making about lung cancer screening, and provide health system navigation when needed.

  • Lung Cancer Screening

    Other intervention

    After participating in shared decision-making, eligible participants will be referred to primary care physician or existing specialist to complete lung cancer screening.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: C-Raven + CHW Smoking Cessation InterventionExperimental treatment 4 interventions
Group B: No InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Acceptability and Feasibility as assessed by number of participants who complete modules

Time frame
1 month
2

Acceptability and Feasibility as assessed by number of sessions with CHW

Time frame
1 month, 3 months, 6 months
3

Number of participants who uptake Low-dose CT Scan

Time frame
3 months, 6 months

Secondary outcomes

1

Readiness to Quit as assessed by The Readiness Ruler

The Readiness Ruler is a brief measure of motivation, which uses 10-point visual analog scales on which the participant rates importance, confidence, and readiness, with a score of 0 reflecting "not ready," and a score of 10 reflecting "ready."

Time frame
1 month, 3 months, 6 months
2

Number of participants who uptake Nicotine Replacement Therapy (NRT)

Time frame
3 months, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Maryland Cigarette Restitution Fund

Collaborator

Source ClinicalTrials.gov
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