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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05095779
Other study ID # 13859
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2022
Est. completion date August 11, 2023

Study information

Verified date January 2024
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation counseling and self-reported abstinence at follow-up among Oklahoma Tobacco Helpline (OTH) callers living in persistent poverty counties (PPCs). The study will enroll at least 160 adults who reside in any of the 16 persistent poverty counties in Oklahoma, who are seeking smoking cessation treatment through the OTH.


Description:

The proposed randomized controlled trial will enroll adults who are seeking smoking cessation treatment through the OTH and who reside in any of the 16 PPCs in Oklahoma. Participants will be randomly assigned to OTH or OTH plus escalating incentives (OTH+I) for completing up to 5 counseling calls over 8 weeks. Feasibility outcomes for the incentives-based intervention will focus on counseling call completion, follow-up assessment completion, smoking cessation, incentive costs, and perceptions of the intervention. Potential effectiveness will be evaluated based on comparisons of counseling call completions and rates of self-reported smoking abstinence at 12 weeks post-enrollment (4 weeks after incentives have ended) in OTH+I relative to OTH alone.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date August 11, 2023
Est. primary completion date August 11, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Contact the OTH seeking smoking cessation treatment 2. Reside in any of the 16 PPCs in Oklahoma (Adair, Caddo, Cherokee, Choctaw, Greer, Harmon, Haskell, Hughes, Johnston, McCurtain, Okfuskee, Payne, Pushmataha, Seminole, Sequoyah, Tillman) 3. Report smoking = 5 cigarettes per day 4. Are = 18 years of age 5. Are able to provide a copy/photo of their ID/driver's license or other documentation of identity and residence 6. Be able to read, speak, and understand English 7. Have no contradictions for NRT

Study Design


Intervention

Behavioral:
Standard Care + Financial Incentives
Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.
Other:
Standard Care
Financial Incentives participants will receive standard care for completing counseling calls.

Locations

Country Name City State
United States TSET Health Promotion Research Center Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Outcome Measure: The primary outcome measure is self-reported smoking abstinence 7-day point prevalence at 12 weeks post-quit. 12 weeks post-quit-date
Primary Cost-effectiveness The incremental cost effectiveness ratio (ICER) calculated as the difference in mean costs between the new (CM) and standard treatment (SC) divided by the difference in mean effectiveness between the two, estimates additional resources needed to achieve an increase of one unit of effectiveness. The ICER is then compared with published threshold values for cost-effective interventions. The cost model will include all necessary personnel, hardware, and material costs. 12 weeks post-quit-date
Secondary Self-reported smoking abstinence Self-reported 7-day point prevalence abstinence at 8 weeks post-quit-date. 8 weeks post-quit-date
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