- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03962660
Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS)
22 maj 2019 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
94
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Tatiana M Ubay
- Telefonnummer: 206-744-9913
- E-post: tatiubay@uw.edu
Studera Kontakt Backup
- Namn: Emily Taylor
- Telefonnummer: 206-744-1873
- E-post: emt07@uw.edu
Studieorter
-
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Washington
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Seattle, Washington, Förenta staterna, 98195
- Rekrytering
- University of Washington - Harborview Medical Center
-
Kontakt:
- Susan E Collins, PhD
- Telefonnummer: 206-832-7885
- E-post: collinss@uw.edu
-
Huvudutredare:
- Susan E Collins, PhD
-
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Aktiv komparator: Standard Care (SC)
See description below.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Nonsmoking
Tidsram: Change across the 12-month follow-up
|
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.
|
Change across the 12-month follow-up
|
TSNA Concentration
Tidsram: 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.
|
Change across the 12-month follow-up
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
smoking intensity
Tidsram: 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.
|
Change across the 12-month follow-up
|
smoking frequency
Tidsram: 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.
|
Change across the 12-month follow-up
|
CO level
Tidsram: Change across the 12-month follow-up
|
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
|
cotinine levels
Tidsram: Change across the 12-month follow-up
|
Urinary cotinine will reflect participants' recent nicotine use.
|
Change across the 12-month follow-up
|
FEV1%
Tidsram: 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.
|
Change across the 12-month follow-up
|
Clinical COPD questionnaire
Tidsram: Change across the 12-month follow-up
|
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.
|
Change across the 12-month follow-up
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EQ-5D-5L
Tidsram: 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.
|
Change across the 12-month follow-up
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
smoking craving
Tidsram: 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
|
side effects of ENDS
Tidsram: Change across the 12-month follow-up
|
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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 maj 2019
Primärt slutförande (Förväntat)
30 april 2021
Avslutad studie (Förväntat)
31 december 2021
Studieregistreringsdatum
Först inskickad
17 maj 2019
Först inskickad som uppfyllde QC-kriterierna
22 maj 2019
Första postat (Faktisk)
24 maj 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 maj 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 maj 2019
Senast verifierad
1 maj 2019
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- STUDY00006430
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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