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Идёт набор NCT07459621

Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking

Без фазы С лечением Smoking Behaviors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Control Intervention, Experimental Intervention.
Кому может быть актуально
Состояния в реестре: Smoking Behaviors. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking: A Randomized Controlled Trial

Обзор

The goal of this study is to compare the effectiveness of two smoking cessation programs to determine which better helps people change their smoking behavior, the control or the experimental intervention? Both interventions include access to a mHealth app and other publicly available stop-smoking resources. The two app versions each include best practice advice and guidance for quitting smoking, but one includes additional content designed for people who aren't ready to quit smoking. The investigators hypothesize that people who receive the experimental intervention will be more likely to request additional stop-smoking resources offered through the intervention and report smoking abstinence after 6 months. The investigators also hypothesize people assigned to the experimental app will have better app engagement and be more likely to report positive changes in their smoking behavior and use of other evidence-based stop smoking treatments that are publicly available.

Вмешательства

  • Поведенческое Control Intervention
    GEMS mHealth app including standard, best-practice information and advice to support quitting smoking, in-app motivational support, and access to publicly-available, evidence-based stop smoking resources and treatment. App can be used ad-lib during the study duration.
  • Поведенческое Experimental Intervention
    GEMS mHealth app including same standard care, best-practice information and advice for quitting smoking and in-app motivational support as in the control arm, plus additional content designed to help users clarify their values, build motivation for change, and learn skills necessary to quit smoking. App can be used ad-lib during the study duration.

Первичные конечные точки

  • Evidence-based treatment request [Срок оценки: 6-months post-randomization]
  • 7-day Point Prevalence Abstinence (PPA) [Self-report] [Срок оценки: 6-months post-randomization]
Вторичные конечные точки (9)
  • 7-day Point Prevalence Abstinence (PPA) [Self-report] [Срок оценки: 3-months post-randomization]
  • 30-day Point Prevalence Abstinence (PPA) [Self-report] [Срок оценки: 3- and 6-months post-randomization]
  • 7-day Point Prevalence Abstinence (PPA) [Confirmed] [Срок оценки: 6-months post-randomization]
  • Evidence-based treatment request [Срок оценки: 3-months post-randomization]
  • Use of any cessation treatment [Срок оценки: 3- and 6-months post-randomization]
  • Successful 24-hour quit attempt [Срок оценки: By 3-months and 6-months post-randomization]
  • Any quit attempt [Срок оценки: By 3-months and 6-months post-randomization]
  • Change in cigarettes per day [Срок оценки: Baseline to each of 3-months and 6-months post-randomization]
  • Tobacco and nicotine abstinence [Срок оценки: 3- and 6-months post-randomization]

Критерии участия

Критерии включения

  • 18 years of age and older
  • Current cigarette smoker who is ambivalent about smoking
  • Not actively using any treatment to quit smoking
  • Own and regularly use a smartphone
  • State willingness to install and use their assigned app
  • Willingness to receive study communications
  • Smoke at least half a pack a day
  • Meet geolocation requirements

Критерии исключения

  • A lifetime history of dementia or psychosis
  • Visual impairments that prevent viewing phone content and they lack adaptive devices
  • Report medical contra-indications for over-the-counter NRT use
  • Due to the potential for bias introduced by fraudulent participants, other exclusions will be applied to deter fraudulent enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Kaiser Permanente Center for Health Research — Portland

Идентификаторы

NCT: NCT07459621 · 2171564 · R01CA293229

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗