NCT03527667

Brief Summary

This pilot study aims to test the feasibility of providing incentives to patients with T2D contingent on remote biochemical verification using a smartphone carbon monoxide (CO) monitor. The investigators will use an ecological momentary assessment (EMA) smartphone application and CO sensor to monitor urges to smoke, stressors, smoking behaviors, and to validate continuous abstinence throughout the intervention. Two different contingency management structures will be explored to investigate the length of time incentives need to be offered.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 22, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

May 4, 2018

Last Update Submit

December 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of CO readings completed

    Feasibility of study determined by number of CO readings completed by each participant

    12 weeks

Secondary Outcomes (2)

  • Quit outcomes

    12 weeks

  • Cigarettes per day

    12 weeks

Study Arms (3)

Short term incentives

EXPERIMENTAL

usual quit smoking treatment (counseling + medication) plus 6-weeks of payments for proof of smoking abstinence

Behavioral: Financial incentives

Long term incentives

EXPERIMENTAL

usual quit smoking treatment (counseling + medication) plus 12-weeks of payments for proof of smoking abstinence

Behavioral: Financial incentives

No incentives

NO INTERVENTION

usual quit smoking treatment (counseling + medication)

Interventions

Treatment arm participants will receive financial incentives ($20 per week) contingent on biochemically verified smoking abstinence submitted once daily for the time period allocated.

Long term incentivesShort term incentives

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 75
  • Type 2 diabetes diagnosis greater than 1 year prior to enrollment
  • Currently smoking at least 5 cigarettes per day
  • Self-reported quit attempt in past 12 months

You may not qualify if:

  • Unwilling to make a quit attempt
  • Unable to use smartphone iCO monitor following training session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Strathclyde

Glasgow, Scotland, United Kingdom

Location

Related Publications (1)

  • Martinez SA, Quaife SL, Hasan A, McMillan KA, Beebe LA, Muirhead F. Contingency management for smoking cessation among individuals with type 2 diabetes: protocol for a multi-center randomized controlled feasibility trial. Pilot Feasibility Stud. 2020 Jun 11;6:82. doi: 10.1186/s40814-020-00629-7. eCollection 2020.

MeSH Terms

Conditions

Smoking CessationDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sydney A Martinez, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3-arm randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 17, 2018

Study Start

June 22, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

December 6, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations