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LEARN-undersøgelsen til forebyggelse af hjerte-kar-sygdomme (LEARN)

14. juli 2026 opdateret af: Yale University

LEveraging A Virtual Environment (LEARN) for at forbedre forebyggelsen af ​​hiv-relaterede komorbiditeter i udsatte minoritets-MSM

Efterforskeren tester et virtuelt miljø for at adressere forebyggelse af hiv-relaterede følgesygdomme.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Det primære formål med denne undersøgelse er at teste gennemførligheden, acceptabiliteten og de foreløbige virkninger af en VE for at adressere forebyggelse af HIV-relaterede komorbiditeter. Et klinisk gennemførlighedsstudie for ventelistekontrol vil blive udført. Vi vil tildele (N=80) kvalificerede deltagere og sikre en balanceret fordeling til interventions- og kontrolgrupper i løbet af interventionsperioden. Vi antager, at VE vil være gennemførligt og acceptabelt for personer, der lever med hiv, og at de vil anvende deres VE-læring til virkelige situationer og sundhedsadfærd til forebyggelse af hiv-relaterede komorbiditeter.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

78

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Connecticut
      • Orange, Connecticut, Forenede Stater, 06477
        • Yale University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • identificere sig som en etnisk/race minoritet med hiv
  • identificere sig som homoseksuel, samme køn-elskende eller MSM
  • kan læse og forstå engelsk
  • adgang til en computer, der er i stand til at downloade og køre VE-softwaren
  • ingen sygehistorie med alvorlige kardiovaskulære eller kognitive komplikationer

Ekskluderingskriterier:

Alt uden for inklusionsparametre, inklusive historik for:

  • myokardieinfarkt (MI)
  • kongestiv hjertesvigt (CHF)
  • koronararterie bypass graft (CABG)
  • cerebral vaskulær ulykke (CVA)
  • kognitiv svækkelse

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Øjeblikkelig indsatsgruppe
Deltagerne vil deltage i et online spil og lære om, hvordan man forebygger kardiovaskulære og metaboliske tilstande.
For at adressere de primære resultater af gennemførlighed og accept af VE, vil vi fange procesdata ved hjælp af et computerbaseret virtuelt miljø og selvrapporteringsforanstaltninger ved hjælp af en online-undersøgelse.
Andet: Venteliste kontrolgruppe
Deltagerne vil gå ind i et online spil på et senere tidspunkt efter den øjeblikkelige interventionsgruppe og lære om, hvordan man forebygger kardiovaskulære og metaboliske tilstande.
For at adressere de primære resultater af gennemførlighed og accept af VE, vil vi fange procesdata ved hjælp af et computerbaseret virtuelt miljø og selvrapporteringsforanstaltninger ved hjælp af en online-undersøgelse.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of Virtual Environment Intervention
Tidsramme: Baseline through Month 6
Feasibility was operationalized through recruitment metrics (proportion of individuals who enrolled from those initially contacted) and retention metrics (percentage of participants who completed 3-month and 6-month follow-up assessments from baseline analysis sample).
Baseline through Month 6
Acceptability of Virtual Environment- Engagement
Tidsramme: 6-month intervention period
Acceptability was evaluated through engagement with the VE measured via platform metadata and logfile analysis.
6-month intervention period
Acceptability of Virtual Environment- Total Sessions
Tidsramme: 6-month intervention period
Acceptability was evaluated through total sessions logged in the VE measured via platform metadata and logfile analysis.
6-month intervention period
Acceptability of Virtual Environment- Mean Session Duration
Tidsramme: 6-month intervention period
Acceptability was evaluated through mean session duration in the VE in minutes measured via platform metadata and logfile analysis.
6-month intervention period
Acceptability of Virtual Environment- Total Educational Quests Accessed
Tidsramme: 6-month intervention period
Acceptability was evaluated through the total number of distinct educational quests accessed in the VE measured via platform metadata and logfile analysis.
6-month intervention period
Acceptability of Virtual Environment- Percent VE District Visits
Tidsramme: 6-month intervention period
Acceptability was evaluated through the percentage of visits for each of the districts within the VE measured via platform metadata and logfile analysis.
6-month intervention period
Acceptability of Virtual Environment- Total Engagements Per Module
Tidsramme: 6-month intervention period
Acceptability was evaluated through total number of engagements per module in the VE measured via platform metadata and logfile analysis.
6-month intervention period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Mass Index (BMI)
Tidsramme: Baseline and Month 3 & 6

Between group change from baseline in Body Mass Index (BMI) represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70.

Positive values are favorable for intervention; negative values are unfavorable for intervention.

Baseline and Month 3 & 6
Change in Physical Activity
Tidsramme: Baseline and Month 3
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a validated questionnaire that assesses physical activity through self-reported frequency and duration. Walking includes any walking for work, transport, or recreation (3.3 Metabolic Equivalent of Task or METs). Moderate-intensity activity includes activities requiring moderate effort such as carrying light loads or recreational swimming (4.0 METs). Vigorous-intensity activity includes activities requiring hard physical effort such as running or aerobics (8.0 METs). Total physical activity is calculated as MET-minutes per week (MET value × minutes × days). Values are reported as minutes per week or MET-minutes per week, with a minimum of 0 and no fixed maximum. Higher values indicate greater physical activity, which is favorable for cardiovascular health. Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; La
Baseline and Month 3
Change in Physical Activity
Tidsramme: Baseline and Month 6
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a validated questionnaire that assesses physical activity through self-reported frequency and duration. Walking includes any walking for work, transport, or recreation (3.3 Metabolic Equivalent of Task or METs). Moderate-intensity activity includes activities requiring moderate effort such as carrying light loads or recreational swimming (4.0 METs). Vigorous-intensity activity includes activities requiring hard physical effort such as running or aerobics (8.0 METs). Total physical activity is calculated as MET-minutes per week (MET value × minutes × days). Values are reported as minutes per week or MET-minutes per week, with a minimum of 0 and no fixed maximum. Higher values indicate greater physical activity, which is favorable for cardiovascular health. Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; La
Baseline and Month 6
Tobacco and E-cigarette Use- Question 1
Tidsramme: Baseline
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 1: "Have you smoked at least 100 cigarettes in your entire life?"
Baseline
Tobacco and E-cigarette Use- Question 2
Tidsramme: Baseline
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 2 "Do you now smoke cigarettes every day, some days, or not at all?"
Baseline
Tobacco and E-cigarette Use- Question 3
Tidsramme: Baseline
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 3: "During the past 12 months, have you stopped smoking for one day or longer because you were trying to quit smoking?"
Baseline
Tobacco and E-cigarette Use- Question 4
Tidsramme: Baseline
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 4: "How long has it been since you last smoked a cigarette, even one or two puffs?"
Baseline
Tobacco and E-cigarette Use- Question 5
Tidsramme: Baseline
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 5: "Do you currently use chewing tobacco, snuff, or snus every day, some days, or not at all?"
Baseline
Tobacco and E-cigarette Use- Question 6
Tidsramme: Baseline
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 6: "Have you ever used an e-cigarette or other electronic "vaping" product, even just one time, in your entire life?"
Baseline
Tobacco and E-cigarette Use- Question 7
Tidsramme: Baseline
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use. Participants were asked: Question 7: "Do you now use e-cigarettes or other electronic "vaping" products every day, some days, or not at all?"
Baseline
Change in Nutrition Intake
Tidsramme: Baseline and Month 3
Dietary intake was assessed using the NCI Multifactor Screener, a validated food frequency questionnaire that reports how frequently individuals consume foods in 6 categories. Vegetables, fruit, and whole grains were measured as average daily servings; sweets, red meat, and fast food were measured as weekly servings or meals. Values are self-reported counts with a minimum of 0 and no fixed maximum. Adherence was evaluated against dietary guidelines recommending ≥3 servings of vegetables and ≥2.5 servings of fruit daily. For vegetables, fruit, and whole grains, higher values indicate healthier dietary patterns (favorable). For sweets, red meat, and fast food, lower consumption is favorable for cardiovascular health. Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention.
Baseline and Month 3
Change in Nutrition Intake
Tidsramme: Baseline and Month 6
Dietary intake was assessed using the NCI Multifactor Screener, a validated food frequency questionnaire that reports how frequently individuals consume foods in 6 categories. Vegetables, fruit, and whole grains were measured as average daily servings; sweets, red meat, and fast food were measured as weekly servings or meals. Values are self-reported counts with a minimum of 0 and no fixed maximum. Adherence was evaluated against dietary guidelines recommending ≥3 servings of vegetables and ≥2.5 servings of fruit daily. For vegetables, fruit, and whole grains, higher values indicate healthier dietary patterns (favorable). For sweets, red meat, and fast food, lower consumption is favorable for cardiovascular health. Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention.
Baseline and Month 6
Change in Psychosocial Wellbeing
Tidsramme: Baseline and Month 3 & 6
The Patient Health Questionnaire-9 (PHQ-9) is a validated 9-item questionnaire used to screen for depression. Each item is scored 0-3, with total scores ranging from 0 to 27. Severity categories: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). Higher scores indicate greater severity of depressive symptoms (unfavorable). Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention.
Baseline and Month 3 & 6
Change in Revised Illness Perceptions Questionnaire
Tidsramme: Baseline and Month 3
Assesses cognitive and emotional representations of illness using 5-point Likert scales (1 = strongly disagree, 5 = strongly agree). Subscale scores are calculated as sum totals with the following ranges: Timeline Acute/Chronic (3-15), Timeline Cyclical (4-20), Consequences (5-25), Personal Control (4-20), Treatment Control (4-20), Illness Coherence (4-20), and Emotional Representations (6-30). Higher scores indicate stronger beliefs in each domain. For Personal Control, Treatment Control, and Illness Coherence, higher scores indicate more adaptive beliefs (favorable). For Consequences and Emotional Representations, higher scores indicate more negative perceptions (unfavorable). Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention.
Baseline and Month 3
Change in Revised Illness Perceptions Questionnaire
Tidsramme: Baseline and Month 6

The Revised Illness Perception Questionnaire was used to assess perceptions about hypertension and diabetes on a 5-point Likert scale ("strongly disagree" to "strongly agree") over 8 dimensions. Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70.

Positive values are favorable for intervention; negative values are unfavorable for intervention.

Baseline and Month 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Yale University School of Nursing

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. maj 2023

Primær færdiggørelse (Faktiske)

31. marts 2025

Studieafslutning (Faktiske)

31. marts 2025

Datoer for studieregistrering

Først indsendt

28. oktober 2020

Først indsendt, der opfyldte QC-kriterier

7. februar 2022

Først opslået (Faktiske)

16. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

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