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临床试验/NCT05799625
NCT05799625进行中(未招募)不适用

An Interactive Smartphone Application to Motivate Smokers to Quit

Ottawa Heart Institute Research Corporation1 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2024年3月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
382
试验地点
1
主要终点
Self-reported readiness to quit

研究概览

简要总结

Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking.

详细描述

Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking. The intervention has been designed based by a team of scientist, taking principles of change behaviour into consideration. The application incorporates daily reminders, gamification, and models of habit formation to engage users. It will support participants to reflect on their smoking in a holistic manner through questions and activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older.
  • Living in Ontario, Canada.
  • Current smoker who indicates they are not interested in quitting within the next 30-days.
  • Have access to and regularly use a smartphone with internet access.
  • Read, write, speaks English or French.
  • Available and willing to participate in follow-up assessments over the next 6 months.
  • Able to provide consent.

排除标准

  • Planning on quitting smoking within the next 30-days.
  • Cognitively impaired or experiencing acute psychiatric illness that would alter their ability to participate.
  • Institutionalized at a retirement home, nursing home or long-term care facility.
  • Has morbid illness which will prevent completion of 6-month follow-up (e.g., receiving palliative care).
  • Participating in another smoking cessation program

研究组 & 干预措施

Usual Care

No Intervention

Eligible smokers randomized to usual care will receive an educational brochure for the University of Ottawa Heart Institute's Ottawa Model for Smoking Cessation (OMSC) Community Program. The brochure will include information about the OMSC Community Program and how to register for it to receive assistance to quit smoking.

Intervention

Experimental

Eligible smokers randomized to the intervention group will be asked to download the StepOne smartphone application onto their smartphone via the Apple Store or Google Play Store. They will be provided with a unique ID and unique code, which will enable them to log into the StepOne smartphone application to begin the 14-day program. Users will interact with the application in the morning and evening; the exact time of the engagement is selected by the participant and ideally at a time that maximizes the likelihood of engaging with the activity. The application incorporates interactive educational material, daily reminders, gamification, and models of habit formation to engage users. As with any other smartphone application, users can turn off notifications if they choose to do so. New content and activities will be shared daily.

干预措施: StepOne Smartphone Application (Behavioral)

结局指标

主要结局

Self-reported readiness to quit

时间窗: Day 195

Collected via survey

Having made a quit attempt

时间窗: Day 195

Collected via survey

Rate of smoking cessation

时间窗: Day 195 for participants who report smoking cessation

Biochemically verified using an expired carbon monoxide (CO) test

Self-reported readiness to quit

时间窗: Day 14

Collected via survey

Self-reported readiness to quit

时间窗: Day 45

Collected via survey

Having made a quit attempt

时间窗: Day 14

Collected via survey

Having made a quit attempt

时间窗: Day 45

Collected via survey

Rate of smoking cessation

时间窗: Day 45 for participants who report smoking cessation

Biochemically verified using an expired carbon monoxide (CO) test

次要结局

  • Use of behavioural supports (e.g. counselling, quit lines)(Day 14, 45, 195)
  • Number of participants that made a quit attempt(Day 14, 45, 195)
  • Point prevalence abstinence(Day 14, 45, 195)
  • Use of cessation medication and/or e-cigarettes(Day 14, 45, 195)
  • Satisfaction and perceived program barriers and facilitators will be assessed for patients in the intervention group(Day 14, 45, 195)
  • Change in smoking(Day 14, 45, 195)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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