Family-Based Financial Incentives Intervention for Smoking Cessation (Aniqsaaq-RCT)

Mayo Clinic

Status: Enrolling

Conditions: Smoking Cessation

Treatments: Behavioral: Financial Incentive Rewards

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06556433

2024-04-015

1R01DA056469-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

The current study will conduct an RCT to evaluate the effectiveness of a family-based incentive intervention with Alaska Native/American Indian families. The experimental arm will be compared to a control arm on biochemically-confirmed smoking abstinence at 6- and 12-months post-intervention.

Full description

Dyads will be stratified by the index participant's sex, and residence with family member, and by the family member's current smoking status then randomized to a no incentives control condition (n=328 dyads) or a 6-month incentive intervention (n=328 dyads).

All dyads will receive existing evidence-based cessation materials on treatment resources and social support strategies. The study will measure the index participant's smoking status in both study groups weekly during the first four weeks, and at three and six months. All participants, including support persons, will receive incentives when they complete each of the smoking status assessments. The intervention group will additionally receive individual rewards provided to the index participant for achieving verified smoking abstinence at each time point, to a maximum of $750.

The enrolled family member will also receive rewards equivalent to the value earned by the index participant that can contribute to family needs. The study will explore potential moderators (e.g., family member smoking status, index participant's sex) and mediators (e.g., interdependence) of intervention effects.

Enrollment: 1,312 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Index Participant Inclusion Criteria:

• Alaska Native/American Indian (ANAI) person (based on self-reported race) and reside in Alaska.
• Age ≥18 years.
• Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 ng/mL (positive result based on at-home saliva swab test provided by study team).
• Smoked ≥ 3 cigarettes per day over the past 3 months.
• Considering or willing to make a quit attempt.
• Have or will nominate one adult family member to enroll with them.
• Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration
• Willing to upload photos of self during completion of smoking status tests.
• Willing to complete and sign an Internal Revenue Service (IRS) W-9 tax identification form if they wish to receive payments on the study.
• Willing to provide written informed consent and participate in study-related tests and procedures.

Index Participant Exclusion Criteria:

• Already enrolled in the study with another family member.
• Participated in a prior study phase.

Family Member Participant Inclusion Criteria (regardless of smoking status or residence with the index participant):

• Age ≥18 years.
• Defined as family and nominated by the index participant, or have an ANAI family member who is ≥18 years and smokes that they would like to support in quitting.
• Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration.
• Willing to complete and sign an IRS W-9 tax identification form if they wish to receive payments on the study.
• Willing to provide written informed consent and participate in study related tests and procedures.

Both men and women, those from non-ANAI racial/ethnic groups, and those who live outside of Alaska in the United States will be eligible family member participants.

Family Member Participant Exclusion Criteria:

• Already enrolled with another family member.
• Participated in a prior study phase.

After the randomized controlled trial, qualitative interviews will be conducted with index participants, family member participants, and Alaska Tribal Health System Stakeholders to inform program implementation. Healthcare providers, cessation specialists, Elder advisors, and Tribal Health System leaders and stakeholders will be invited by the Alaska Native Tribal Health Consortium team and separately consented and interviewed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,312 participants in 2 patient groups

Rewards Group

Experimental group

Description:

Index participants in the Rewards Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Rewards Group will receive informational materials on smoking cessation.

Treatment:

Behavioral: Financial Incentive Rewards

Comparison Group

No Intervention group

Description:

Index participants in the Comparison Group will be scheduled to complete smoking status check-ins six times during the 6-month Treatment Phase: weekly for four weeks, then at three and six months. At each check-in, cigarette smoking abstinence will be assessed. Participants in the Comparison Group will receive informational materials on smoking cessation.