- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05242952
LEARN-undersøgelsen til forebyggelse af hjerte-kar-sygdomme (LEARN)
LEveraging A Virtual Environment (LEARN) for at forbedre forebyggelsen af hiv-relaterede komorbiditeter i udsatte minoritets-MSM
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Connecticut
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Orange, Connecticut, Forenede Stater, 06477
- Yale University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
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
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 |
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Eksperimentel: Øjeblikkelig indsatsgruppe
Deltagerne vil deltage i et online spil og lære om, hvordan man forebygger kardiovaskulære og metaboliske tilstande.
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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.
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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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of Virtual Environment Intervention
Tidsramme: Baseline through Month 6
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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).
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Baseline through Month 6
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Acceptability of Virtual Environment- Engagement
Tidsramme: 6-month intervention period
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Acceptability was evaluated through engagement with the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Total Sessions
Tidsramme: 6-month intervention period
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Acceptability was evaluated through total sessions logged in the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Mean Session Duration
Tidsramme: 6-month intervention period
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Acceptability was evaluated through mean session duration in the VE in minutes measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Total Educational Quests Accessed
Tidsramme: 6-month intervention period
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Acceptability was evaluated through the total number of distinct educational quests accessed in the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Percent VE District Visits
Tidsramme: 6-month intervention period
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Acceptability was evaluated through the percentage of visits for each of the districts within the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Total Engagements Per Module
Tidsramme: 6-month intervention period
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Acceptability was evaluated through total number of engagements per module in the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Body Mass Index (BMI)
Tidsramme: Baseline and Month 3 & 6
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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
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Change in Physical Activity
Tidsramme: Baseline and Month 3
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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
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Baseline and Month 3
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Change in Physical Activity
Tidsramme: Baseline and Month 6
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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
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Baseline and Month 6
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Tobacco and E-cigarette Use- Question 1
Tidsramme: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 2
Tidsramme: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 3
Tidsramme: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 4
Tidsramme: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 5
Tidsramme: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 6
Tidsramme: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 7
Tidsramme: Baseline
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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?"
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Baseline
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Change in Nutrition Intake
Tidsramme: Baseline and Month 3
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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.
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Baseline and Month 3
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Change in Nutrition Intake
Tidsramme: Baseline and Month 6
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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.
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Baseline and Month 6
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Change in Psychosocial Wellbeing
Tidsramme: Baseline and Month 3 & 6
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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.
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Baseline and Month 3 & 6
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Change in Revised Illness Perceptions Questionnaire
Tidsramme: Baseline and Month 3
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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.
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Baseline and Month 3
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Change in Revised Illness Perceptions Questionnaire
Tidsramme: Baseline and Month 6
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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
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Yale University School of Nursing
Publikationer og nyttige links
Generelle publikationer
- Ramos SR, Warren R, Shedlin M, Melkus G, Kershaw T, Vorderstrasse A. A Framework for Using eHealth Interventions to Overcome Medical Mistrust Among Sexual Minority Men of Color Living with Chronic Conditions. Behav Med. 2019 Apr-Jun;45(2):166-176. doi: 10.1080/08964289.2019.1570074.
- Ramos SR, O'Hare OM, Hernandez Colon A, Kaplan Jacobs S, Campbell B, Kershaw T, Vorderstrasse A, Reynolds HR. Purely Behavioral: A Scoping Review of Nonpharmacological Behavioral and Lifestyle Interventions to Prevent Cardiovascular Disease in Persons Living With HIV. J Assoc Nurses AIDS Care. 2021 Sep-Oct 01;32(5):536-547. doi: 10.1097/JNC.0000000000000230.
- Ramos SR, Johnson C, Melkus G, Kershaw T, Gwadz M, Reynolds H, Vorderstrasse A. Cardiovascular Disease Prevention Education Using a Virtual Environment in Sexual-Minority Men of Color With HIV: Protocol for a Sequential, Mixed Method, Waitlist Randomized Controlled Trial. JMIR Res Protoc. 2022 May 17;11(5):e38348. doi: 10.2196/38348.
- Ramos SR, Reynolds H, Johnson C, Melkus G, Kershaw T, Thayer JF, Vorderstrasse A. Perceptions of HIV-Related Comorbidities and Usability of a Virtual Environment for Cardiovascular Disease Prevention Education in Sexual Minority Men With HIV: Formative Phases of a Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Aug 22;26:e57351. doi: 10.2196/57351.
- Ramos SR, Boerger L, Restar AJ, Phadke M, Jeon S, Johnson C, Melkus G, Kershaw T, Reynolds H, Vorderstrasse A. A Web-Based Virtual Environment Behavioral Intervention as Cardiovascular Disease and Metabolic Disease Prevention Education in Persons With HIV: Evaluation of the LEARN Randomized Controlled Trial. J Med Internet Res. 2026 Jun 15;28:e91145. doi: 10.2196/91145.
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
Nøgleord
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i immunsystemet
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Opførsel
- Seksuel adfærd
- HIV-infektioner
- Hjerte-kar-sygdomme
- Coitus
Andre undersøgelses-id-numre
- 2000031403
- 1K01HL145580-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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