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Randomized Controlled Trial (RCT) of a Motivational Decision Support System (RCTEDSS)

3. november 2018 oppdatert av: Mary F. Brunette, MD, Dartmouth-Hitchcock Medical Center

RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses

In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. The Specific Aims of the study are:

  1. To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence.
  2. To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed.

  3. To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months

    1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.
    2. We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Up to 80% of people with schizophrenia and schizoaffective disorders smoke - a rate that is four times the rate in the general population. Cessation treatments are effective, but these smokers don't use them. In order to provide an easy-to-use, cost-effective strategy to engage this group of smokers into effective treatments, we developed a single-session, web-based, motivational decision support system, Let's Talk About Smoking. The system incorporates features that insure high usability among those who can't use current websites due to cognitive impairments and low computer skills. It provides compelling content that engages users into evidence-based cessation treatments.

In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. Our proposed study design will enable us to test whether this system, designed for those with cognitive impairments, is effective among people with a range of cognitive abilities. The Specific Aims of the study are:

  1. To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence.
  2. To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed.

  3. To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months

    1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.
    2. We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.

Studietype

Intervensjonell

Registrering (Faktiske)

184

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater, 60613
        • Thresholds
    • Massachusetts
      • Worcester, Massachusetts, Forente stater, 01605
        • University of Massachusetts
    • New Jersey
      • New Brunswick, New Jersey, Forente stater, 08901
        • Rutgers-UNDMJ

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 18-70 years old
  • DSM-IV-TR diagnosis psychotic disorder
  • in treatment at participating mental health center
  • current daily smoker
  • fluent in English
  • physically able to use computer
  • willing and able to give informed consent

Exclusion Criteria:

  • past 2 weeks use of evidence based cessation treatment
  • psychiatric instability
  • current alcohol or drug dependence
  • pregnant or nursing

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Behavioral intervention
Web-based motivational decision support system
Atferdsmessig: Web-based motivational decision support system
Aktiv komparator: Educational intervention
Computerized version of the National Cancer Institute (NCI) Educational Pamphlet
Atferdsmessig: NCI Education

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Subjects That Initiated Cessation Treatment
Tidsramme: 6 months
Cessation treatment initiation and engagement will be collected from clinician attendance sheets in the medical record and medical record review for prescriptions. Medication use will be confirmed with self-report of taking medication.
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Subjects With Confirmed Abstinence
Tidsramme: 6 months
Biologically confirmed abstinence: we will confirm 7-day point prevalence abstinence at 6 month assessments (self-reported abstinence without any smoking, "not even a puff," for the past 7 days,) with expired carbon monoxide (reading ≤9).
6 months
Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence
Tidsramme: 6 months
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dartmouth-Hitchcock Medical Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Mary F. Burnette, MD, Dartmouth-Hitchcock Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2014

Primær fullføring (Faktiske)

1. juli 2016

Studiet fullført (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først innsendt

11. mars 2014

Først innsendt som oppfylte QC-kriteriene

11. mars 2014

Først lagt ut (Anslag)

13. mars 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. november 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2018

Sist bekreftet

1. november 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FED14095
  • R01CA168778 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified research data files will be made available to all researchers in both the public and private sectors for potential statistical analyses or re-analyses in accordance with the NIH data Sharing Policy: http://grants.nih.gov/grants/policy/data sharing. Data will be available 2 years after data collection is completed, or after primary papers have been accepted for publication. Data will only be transferred to other researchers under a signed data sharing agreement.

Materials and research data files will be made available, upon request, from the PI. These requests can be made via email (mary.f.brunette@dartmouth.edu).

IPD-delingstidsramme

Data will be available for sharing after we complete our analyses, estimated to be in January 2020.

Tilgangskriterier for IPD-deling

Investigators wishing to access data will submit a request with an analysis plan, data management plan and data safety plan to the PI. A signed data sharing agreement will be developed prior to release of the data.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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