- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04376489
Projekt MARS: Mobilhjælp til regulering af rygning (MARS)
Ny brug af mHealth-data til at identificere tilstande af sårbarhed og modtagelighed over for JITAI'er
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Adfærdsmæssigt: Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are available)
- Adfærdsmæssigt: Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are available)
- Adfærdsmæssigt: Messages recommending low effort strategies (participants experiencing negative affect & cigarettes are not available)
- Adfærdsmæssigt: Messages recommending low effort strategies (participants not experiencing negative affect & cigarettes are not available)
- Adfærdsmæssigt: Messages recommending low effort strategies (when participants did not complete the 2-question survey)
- Adfærdsmæssigt: More effortful activity: Moodsurf
- Adfærdsmæssigt: More effortful activity: Meditate
- Adfærdsmæssigt: More effortful activity: Joy
- Adfærdsmæssigt: More effortful activity: Imagine
- Adfærdsmæssigt: More effortful activity: Notice
Detaljeret beskrivelse
Mål 1: Identificer sårbarhedstilstande for bortfald: Selvrapporterede og sensorbaserede foranstaltninger vil blive brugt til at identificere empirisk-baserede og teoretisk funderede funktioner på tværs af flere tidsskalaer, der er mest forudsigelige for bortfald. Ved at operationalisere sårbarhed i form af det forudsagte niveau af risiko for bortfald, antager efterforskerne, at (H1) nuværende sårbarhed er repræsenteret af nuværende og/eller nylige høje negative følelser, lave positive følelser, høj trang, lav selveffektivitet, lav selvregulering kapacitet (SRC) og risikofyldt kontekst (f.eks. specifikke steder, såsom en bar; tilgængelige cigaretter; andre, der ryger).
Mål 2: Identificer tilstande af modtagelighed for at engagere sig i selvregulerende aktiviteter: Selvrapporterede og sensorbaserede foranstaltninger vil blive brugt til at identificere empirisk-baserede og teoretisk funderede funktioner på tværs af flere tidsskalaer, der er mest forudsigelige for engagement (dvs. brug af selvregulerende aktiviteter). Ved at operationalisere modtagelighed i form af den forudsagte sandsynlighed for engagement, antager efterforskerne, at (H2) nuværende modtagelighed er repræsenteret af høje positive aktiverende følelser (f.eks. glade, taknemmelige), lave negative deaktiverende følelser (f.eks. trist, kedsomhed), lav trang, høj self-efficacy, høj SRC og lav risiko kontekster (f.eks. specifikke steder, såsom hjemmet).
Mål 3: Undersøg tilgange til at drage fordel af tilstande af sårbarhed og modtagelighed for at levere selvreguleringsprompter i realtid. Undersøg om, hvilken type og under hvilke forhold (f.eks. den aktuelle tilstand af sårbarhed og/eller modtagelighed) en opfordring til at engagere individet i selvregulerende aktiviteter øger engagementet og reducerer dermed sårbarheden.
Den foreslåede forskning vil hjælpe med at opbygge et omfattende konceptuelt, teknisk og empirisk grundlag, der er nødvendigt for at udvikle effektive Just-in-Time-Adaptive-Interventions (JITAI'er) baseret på dynamiske modeller for sårbarhed og modtagelighed. I det mikro-randomiserede forsøg (MRT) administreres økologiske momentane vurderinger (EMA'er) før og efter JITAI'er med elementer, der er designet til at måle forskellige indekser, der kan være relateret til deltagernes engagement i JITAI'erne.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84102
- University of Utah
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- 18 år eller ældre
- Aktuel ryger med et gennemsnit på mindst 3 cigaretter/dag
- Motiveret til at stoppe inden for de næste 30 dage
- Gyldig hjemmeadresse
- Fungerende telefonnummer
- Kan tale, læse og skrive på engelsk
- Mindst marginal sundhedsfærdighed (som bestemt af 45 eller højere på REALM læsefærdighedstest)
Ekskluderingskriterier:
- Kontraindikation for nikotinplaster
- Nuværende brug af tobaksstopmedicin eller andre hjælpemidler (dvs. buproprion)
- Graviditet eller amning (som selvrapporteret)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Current Smoker
Within-participant randomization occurred up to 6 times daily to (a) no intervention prompt (b) a prompt recommending a brief (low effort) self-regulatory strategy, or (c) a prompt recommending a more effortful self-regulatory strategy.
|
Participants receive messages tailored for situations when they experiencing negative affect & cigarettes are available.
Participants receive messages tailored for situations when they are not experiencing negative affect & cigarettes are available.
Participants receive messages tailored for situations when they are experiencing negative affect & cigarettes are not available.
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
Smart phone app that teaches participants a mindfulness-based technique in which participant "surf" the mood.
Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.
Smart phone app that teaches participants to practice breathing exercise.
Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.
Smart phone app that teaches participants to accept their thoughts and feelings.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Randomized Decision Points in Which Participant Reported Proximal Engagement by Randomized Assignment
Tidsramme: 1 hour following micro-randomization
|
Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy. Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below. The three EMA items used to operationalize PE were:
Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant. |
1 hour following micro-randomization
|
|
Proportion of Randomized Decision Points in Which the Participant Reported Proximal Engagement by Randomized Assignment.
Tidsramme: 1 hour following micro-randomization
|
Within-person randomization occurred (2:1:1) up to 6 times daily for 10 days to (a) no intervention prompt (b) prompt to engage with a low effort strategy or (c) prompt to engage with a more effortful strategy. Proximal Engagement (PE) with strategies is a binary indicator of engagement, coded as 1 (engaged) if the participant answered "Yes" to at least one of the three items below and as 0 (not engaged) if they answered "No" to all three items below. The three EMA items used to operationalize PE were:
Proportions were first determined for each participant, then averaged across participants. There were up to 60 decision points per participant. |
1 hour following micro-randomization
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proximal Cigarette Use
Tidsramme: approximately 1 hour following the decision point
|
Proximal Cigarette Use (PCU) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of Proximal Cigarette Use was created, coded as 1 if the response included "Cigarettes" and 0 otherwise. This outcome measure reports the proportion that reported PCU at 1 hour following micro-randomization. The intent of this Outcome Measures is to report overall PCU use according to participant's self-reported engagement with self-regulatory strategies. |
approximately 1 hour following the decision point
|
|
Proximal Nicotine-Containing Non-Cessation Product (NCNCP) Use
Tidsramme: approximately 1 hour following the decision point
|
Proximal Nicotine-Containing Non-Cessation Product Use (NCNCP) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of Proximal NCNCP Use was created, coded as 1 if the response included "Cigarettes", "Vape pen, JUUL, or e-cigarette," "Cigars, cigarillos, or little cigars," or "Smokeless tobacco/snus/dissolvable tobacco," and 0 otherwise. This outcome measure will report the proportion that reported NCNCP Use at 1 hour following micro-randomization. |
approximately 1 hour following the decision point
|
|
Proximal Tobacco Product Use (PTPU) Use
Tidsramme: approximately 1 hour following the decision point
|
Proximal Nicotine-Containing Non-Cessation Product Use (PTPU) was assessed with the EMA item, "Since the last assessment, did you use any of the following (check all that apply): Cigarettes; Vape pen, JUUL, or e-cigarettes; Cigars, cigarillos, or little cigars; Smokeless tobacco/snus/dissolvable tobacco; Marijuana/Cannabis; Alcohol; None." A binary indicator of PTPU was created, coded as 1 if the response included "Cigarettes", "Cigars, cigarillos, or little cigars," or "Smokeless tobacco/snus/dissolvable tobacco," and 0 otherwise. This outcome measure will report the proportion that reported PTPU at 1 hour following micro-randomization. |
approximately 1 hour following the decision point
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: David Wetter, PhD, University of Utah
- Ledende efterforsker: Inbal Nahum-Shani, PhD, University of Michigan
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 112287
- U01CA229437-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .