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- Klinische proef NCT04340102
Development of a Scalable Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness
4 november 2020 bijgewerkt door: Melanie Bennett, University of Maryland, Baltimore
All patients with serious mental illness are abstinent while in the hospital for a psychiatric admission yet almost all return to smoking after discharge.
The investigators propose to adapt a digital intervention both to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting through a collaboration between experts in SMI and the Truth Initiative, a pre-eminent tobacco control organization.
The investigators believe this will bridge the inpatient to outpatient gap in cessation services and will help people remain abstinent following hospital discharge.
Studie Overzicht
Gedetailleerde beschrijving
Persons with serious mental illness (SMI, schizophrenia, bipolar disorder, recurrent depression) are a socioeconomically disadvantaged group and die on average 10-15 years earlier than those in the general population, many from cancer.
The prevalence of smoking in persons with SMI is approximately 3 times that in the general population; smoking is the is the strongest risk factor for elevated mortality in this population.
Psychiatric inpatient admissions are common in SMI and the hospital is an optimal place to provide smoking cessation services.
All patients are abstinent while in the hospital.
The key challenge is how to continue to engage these patients in cessation services to support continued abstinence.
While most receive refer to telephone quitline at discharge, quitlines are not as effective with SMI smokers and almost all return to smoking.
Introducing hospitalized SMI patients to cessation services that can be easily accessed when they leave the hospital offers the best chance of converting initial abstinence into sustained abstinence post-discharge.
A digital intervention that incorporates web-delivered evidence-based smoking cessation practices, digital coaching, and mobile text messaging is a scalable and sustainable way to bridge the inpatient to outpatient gap in cessation services.
Currently there is no digital cessation program that addresses the needs of SMI smokers.
The investigators propose to adapt a digital intervention both to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting through a collaboration between experts in SMI and the Truth Initiative, a pre-eminent tobacco control organization.
The investigators will build upon a well-established, evidence-based, cessation website, BecomeAnEX.org (EX), that offers individualized quit plans, an active social community, text and email messaging support, and digital coaching.
Integrating input from different stakeholders, the investigators will develop adaptations so that EX components and language are in line with principles of mental health recovery and will successfully engage SMI smokers with digital coaching that will support use of other EX services.
The investigators will develop automated and integrated procedures for identifying hospitalized SMI smokers and registering them with EX.
The investigators will then examine the feasibility and acceptability of the adapted intervention to engage and retain 60 smokers with SMI after hospital discharge.
Studietype
Ingrijpend
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- University of Maryland School of Medicine
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Age 18 or greater
- Diagnosis of serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, or major depression)
- Current smoker [prior to admission, smoked at least one cigarette or small cigar per day in the past month (unless restricted, e.g. due to ER/hospital visit) and smoked at least 100 cigarettes lifetime]
- Interested in remaining quit after hospital discharge or quitting within the following 30 days
- Expected Internet use at least several times a week post-discharge and ownership of mobile device with text messaging plan post-discharge
- Sufficiently stable and cooperative to engage in the intervention, operationalized as not on a nursing observation level that indicates high acuity/safety concerns and has participated in a majority of hospital unit activities as documented in the chart during the hospital stay so far
Exclusion Criteria:
- Intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.
- Homeless prior to admission or anticipated to be homeless at discharge.
- Discharge to a residential setting where smoking is prohibited.
- Medical condition for which the use of nicotine replacement therapy (NRT) is contraindicated including pregnant, planning to become pregnant, or breastfeeding; within 4 weeks post myocardial infarction; severe arrhythmia, severe angina pectoris; peptic ulcer; severe renal failure; poorly controlled insulin-dependent diabetes; severely uncontrolled hypertension; peripheral vascular disease.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: BecomeAnEx
Participants will have three individual meetings with a research staff person while they are in the hospital.
At these meetings participants will answer questions about their smoking and interest in quitting, learn about BecomeAnEx, and register with the BecomeAnEx program so that they can use it when you leave the hospital.
Participants will be given two weeks of nicotine replacement therapy when they leave the hospital.
Participants will be asked to use BecomeAnEx as much as they want when they leave the hospital program.
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This research study is focused on a smoking cessation program called BecomeAnEx.
We are studying how to adapt BecomeAnEx for people with a mental health disorder who want to reduce or quit their tobacco smoking.
BecomeAnEx includes a website that provides education about smoking and quitting.
It also has a text messaging program that delivers personalized information.
Persons in the program have access to real-time digital coaching with a remote coach who has experience helping people quit smoking.
In addition, the program has an on-line community of current and former smokers that can provide support and encouragement.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility of recruitment
Tijdsspanne: 2 months
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Rate of recruitment
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2 months
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Feasibility of registration
Tijdsspanne: 2 months
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Time to register with the web based intervention
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2 months
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Acceptability
Tijdsspanne: 2 months
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Satisfaction with the web based intervention using the Client Satisfaction Questionnaire
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2 months
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Acceptability
Tijdsspanne: 2 months
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Satisfaction with the web based intervention using the Services Satisfaction Questionnaire
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2 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
1 juli 2020
Primaire voltooiing (Verwacht)
1 juni 2022
Studie voltooiing (Verwacht)
1 juni 2022
Studieregistratiedata
Eerst ingediend
1 april 2020
Eerst ingediend dat voldeed aan de QC-criteria
6 april 2020
Eerst geplaatst (Werkelijk)
9 april 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 november 2020
Laatste update ingediend die voldeed aan QC-criteria
4 november 2020
Laatst geverifieerd
1 november 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1R21CA237468-01A1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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