- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03962660
Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS)
22 de maio de 2019 atualizado por: 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.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
94
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Washington
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Seattle, Washington, Estados Unidos, 98195
- Recrutamento
- University of Washington - Harborview Medical Center
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Contato:
- Susan E Collins, PhD
- Número de telefone: 206-832-7885
- E-mail: collinss@uw.edu
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Investigador principal:
- Susan E Collins, PhD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
21 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: HaRTS-TRENDS
See description below.
|
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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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Nonsmoking
Prazo: 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
Prazo: Change across the 12-month follow-up
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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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
smoking intensity
Prazo: 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
Prazo: Change across the 12-month follow-up
|
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
Prazo: 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
Prazo: Change across the 12-month follow-up
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Urinary cotinine will reflect participants' recent nicotine use.
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Change across the 12-month follow-up
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FEV1%
Prazo: Change across the 12-month follow-up
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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
Prazo: 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
Prazo: Change across the 12-month follow-up
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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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
smoking craving
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
9 de maio de 2019
Conclusão Primária (Antecipado)
30 de abril de 2021
Conclusão do estudo (Antecipado)
31 de dezembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
17 de maio de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de maio de 2019
Primeira postagem (Real)
24 de maio de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de maio de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de maio de 2019
Última verificação
1 de maio de 2019
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- STUDY00006430
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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