Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS)
22 мая 2019 г. обновлено: Susan Collins, University of Washington
Randomized Controlled Trial of Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS)
This study will evaluate the effectiveness of HaRTS-TRENDS compared to standard care (i.e., brief advice to quit + referral to state quit line that offers free NRT) in facilitating a biochemically verified nonsmoking and b) reducing smoking-related harm as measured by concentration of urinary tobacco-specific nitrosamines (TSNAs).
Potential underlying mechanisms of changes in the proposed outcomes--including nicotine craving and smoking reduction, respectively--will be tested.
Обзор исследования
Статус
Неизвестный
Условия
Вмешательство/лечение
Подробное описание
The prevalence of smoking and smoking-related illness is disproportionately higher among people experiencing chronic homelessness than among people in the general population.
Unfortunately, smoking cessation treatment does not reach or engage the overwhelming majority of smokers experiencing chronic homelessness, and smoking-related harm persists even after people are housed.
There have therefore been calls for more flexible and client-centered approaches tailored to this population's needs.
In response, we are proposing a randomized controlled trial (RCT) of Harm-Reduction for Tobacco Smoking with support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS) as an innovative, empirically informed, and client-driven alternative to traditional smoking cessation treatment.
To maximize its efficacy, the 4-session, individual HaRTS-TRENDS was collaboratively designed with a community advisory board made up of researchers, people with lived experience of chronic homelessness and smoking, and staff and management at a nonprofit, community-based housing agency.
HaRTS-TRENDS entails the provision of electronic nicotine delivery systems (ENDS) in conjunction with harm-reduction counseling.
Interventionists embody a compassionate, advocacy-oriented "heart-set" or style and deliver manualized components that include a) participant-led tracking of preferred smoking outcomes, b) elicitation of participants' harm-reduction goals and their progress toward achieving them, c) discussion of the relative risks of various nicotine delivery systems, and d) instruction in using ENDS.
The proposed study will feature a randomized controlled trial (N=94) of HaRTS-TRENDS among smokers with lived experience of chronic homelessness who have moved into permanent, supportive housing.
Participants will be randomized to receive HaRTS-TRENDS or standard care.
The standard care, which is what people most commonly receive from providers, is brief advice to quit plus referral to the Washington State quitline where participants have access to free NRT.
All participants will be assessed at baseline and posttest as well as at 1-, 3-, 6-, and 12-month follow-ups.
Analyses will be conducted to test the efficacy of HaRTS-TRENDS compared to SC in a) facilitating biochemically verified nonsmoking and b) reducing smoking-related harm as measured by concentration of urinary tobacco-specific nitrosamines (TSNAs).
It is hypothesized that, compared to SC participants, HaRTS-TRENDS participants will show a significantly greater likelihood of nonsmoking and reduced concentration of TSNAs.
Further, we will examine reductions in smoking craving as a mediator of the HaRTS-TRENDS effect on nonsmoking as well as nonsmoking as a mediator of the HaRTS-TRENDS effect on TSNA concentration.
If its results are positive, this project will lay the groundwork for longer-term objectives including dissemination of HaRTS-TRENDS to researchers, clinicians, and community-based agencies to decrease smoking-related harm for a high-cost and severely affected population.
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
94
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
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Washington
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Seattle, Washington, Соединенные Штаты, 98195
- Рекрутинг
- University of Washington - Harborview Medical Center
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Контакт:
- Susan E Collins, PhD
- Номер телефона: 206-832-7885
- Электронная почта: collinss@uw.edu
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Главный следователь:
- Susan E Collins, PhD
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 21 год до 65 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Having a history of chronic homelessness according to the widely accepted federal definition,
- Being a current DESC client living in one of DESC's participating permanent supportive housing projects,
- Being between 21-65 years of age,
- Being a daily smoker (>4 cigarettes/day in the past year with a breath CO ≥ 6 ppm or salivary cotinine test at level 1 if CO < 6 ppm)
- Having adequate English language skills to understand verbal information and communicate in the study
Exclusion Criteria:
- Use of other tobacco products besides cigarettes ≥ 9 days in the past month
- Refusal or inability to consent to participation in research
- Constituting a risk to the safety and security of other clients or staff.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: HaRTS-TRENDS
See description below.
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HaRTS-TRENDS comprises 4, individual sessions delivered in the context of the interventionist's pragmatic harm-reduction mindset paired with a compassionate, advocacy-oriented "heart-set" or style.
It comprises the delivery of 4 manualized components, including a) participant-led tracking of preferred smoking outcomes, b) elicitation of participants' harm-reduction goals and their progress toward achieving them, c) discussion of the relative risks of various nicotine delivery systems, and d) instruction in using ENDS.
Additionally, HaRTS-TRENDS entails provision of commercially available ENDS.
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Активный компаратор: Standard Care (SC)
See description below.
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The 4-session, individual standard care control condition entails the well-documented and evidence-based 5 As intervention (i.e., Ask about nicotine use, Assess use, Advise to quit smoking, Assist with exploring current smoking/planning smoking cessation, Arrange follow-up).
Part of arranging follow-up is the recommendation to call the smoking quit line, which can supply additional counseling and nicotine replacement therapy.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Nonsmoking
Временное ограничение: Change across the 12-month follow-up
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Biologically verified nonsmoking (i.e., self-reported nonsmoking if corresponding CO measure is < 8) in the past 7 days will serve as a primary outcome as well as a potential mediator of the HaRTS-TRENDS effect on TSNA concentration.
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Change across the 12-month follow-up
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TSNA Concentration
Временное ограничение: Change across the 12-month follow-up
|
This primary outcome entails urinary concentration of a tobacco-specific nitrosamine (i.e., NNK), a key carcinogen in tobacco.
Secondarily, TSNA concentration will be used as a longer-term biochemical index of tobacco use.
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Change across the 12-month follow-up
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
smoking intensity
Временное ограничение: Change across the 12-month follow-up
|
Self-reported smoking intensity is the mean number of cigarettes participants report smoking per day in the 7 days prior to the assessment.
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Change across the 12-month follow-up
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smoking frequency
Временное ограничение: Change across the 12-month follow-up
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Self-reported smoking frequency is the number of days participants report smoking in the 7 days prior to the assessment.
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Change across the 12-month follow-up
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CO level
Временное ограничение: Change across the 12-month follow-up
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Carbon monoxide in exhaled air will be examined secondarily as a continuous measure of reduced smoking-related harm.
It will also be used to biochemically verify the 7-day nonsmoking primary outcome.
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Change across the 12-month follow-up
|
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cotinine levels
Временное ограничение: Change across the 12-month follow-up
|
Urinary cotinine will reflect participants' recent nicotine use.
|
Change across the 12-month follow-up
|
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FEV1%
Временное ограничение: Change across the 12-month follow-up
|
FEV1% is the ratio of predicted lung capacity based on participants' height, age and gender with participants' forced expiratory volume in the first second of expiration as a percentage of the predicted value.
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Change across the 12-month follow-up
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Clinical COPD questionnaire
Временное ограничение: Change across the 12-month follow-up
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The 10-item Clinical COPD Questionnaire will be used to calculate an overall summary score representing respiratory HR-QoL over 3 domains: respiratory symptoms (e.g., shortness of breath), functional state (e.g., ability to climb stairs), and mental state (i.e., concern about getting a cold or breathing getting worse).
The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse HRQoL.
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Change across the 12-month follow-up
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EQ-5D-5L
Временное ограничение: Change across the 12-month follow-up
|
This self-report measure yields 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Additionally, the EuroQoL-Visual Analog Scale (EQ-VAS) is a single item representing health-related quality of life via participants' general assessments of their current health, where 0 = the worst health imaginable and 100 = the best health imaginable.
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Change across the 12-month follow-up
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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smoking craving
Временное ограничение: Change across the 12-month follow-up
|
Smoking craving is a potential mediator of the proposed intervention effects and will be measured using the Questionnaire for Smoking Urges-Brief (QSU-B) consists of 10 items rated on 7-point Likert scales ranging from 0 (strongly disagree) to 6 (strongly agree).
Changes in smoking craving summary scores will be tested as a mediator of the HaRTS-TRENDS effects on complete switchover.
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Change across the 12-month follow-up
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side effects of ENDS
Временное ограничение: Change across the 12-month follow-up
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We will assess participants' experience of known, ENDS-related adverse events (i.e., dry mouth, throat irritation, short-ness of breath, headache, cough, tachycardia, nausea) using a 5-item, 5-point Likert-type questionnaire (ranging from 0=none to 5=severe) that was adapted from the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview.
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Change across the 12-month follow-up
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
9 мая 2019 г.
Первичное завершение (Ожидаемый)
30 апреля 2021 г.
Завершение исследования (Ожидаемый)
31 декабря 2021 г.
Даты регистрации исследования
Первый отправленный
17 мая 2019 г.
Впервые представлено, что соответствует критериям контроля качества
22 мая 2019 г.
Первый опубликованный (Действительный)
24 мая 2019 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
24 мая 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
22 мая 2019 г.
Последняя проверка
1 мая 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- STUDY00006430
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
The proposed research will involve people recruited from prominent Housing First programs serving chronically homeless people who are often multiply affected by psychiatric, medical and substance-use disorders.
The proposed sample will be recruited from a highly vulnerable and marginalized population in a tight-knit urban community.
Furthermore, the partnering agency is well-known for its housing approach, and regularly conducts tours to help inform other housing providers, policy makers, and other public stakeholders about this model to promote replicability.
Thus, even with the removal of all identifiers, we believe that it could become difficult to fully protect the identities of participants and their data (including e-cigarette use and smoking which are not currently allowed in housing).
For these reasons, we do not have immediate plans to share the data collected in the context of the proposed study.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .