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El estudio LEARN para la prevención de ECV (LEARN)

14 de julio de 2026 actualizado por: Yale University

APROVECHAR UN ENTORNO VIRTUAL (LEARN) PARA MEJORAR LA PREVENCIÓN DE COMORBILIDADES RELACIONADAS CON EL VIH EN HSH DE MINORÍAS EN RIESGO

El investigador está probando un entorno virtual para abordar la prevención de comorbilidades relacionadas con el VIH.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Los objetivos principales de este estudio son probar la viabilidad, la aceptabilidad y los efectos preliminares de una VE para abordar la prevención de las comorbilidades relacionadas con el VIH. Se realizará un ensayo clínico de factibilidad de control de lista de espera. Asignaremos (N=80) participantes elegibles y garantizaremos una asignación equilibrada a los grupos de intervención y control durante el período de intervención. Presumimos que la VE será factible y aceptable para las personas que viven con el VIH, y que aplicarán su aprendizaje de VE a situaciones de la vida real y comportamientos de salud para la prevención de comorbilidades relacionadas con el VIH.

Tipo de estudio

Intervencionista

Inscripción (Actual)

78

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Connecticut
      • Orange, Connecticut, Estados Unidos, 06477
        • Yale University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

30 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Descripción

Criterios de inclusión:

  • identificarse como una minoría étnica/racial con VIH
  • identificarse como gay, amante del mismo género o HSH
  • capaz de leer y entender inglés
  • acceso a una computadora capaz de descargar y ejecutar el software VE
  • sin antecedentes médicos de complicaciones cardiovasculares o cognitivas graves

Criterio de exclusión:

Cualquier cosa fuera de los parámetros de inclusión, incluido el historial de:

  • infarto de miocardio (IM)
  • insuficiencia cardiaca congestiva (CHF)
  • injerto de derivación de arteria coronaria (CABG)
  • accidente vascular cerebral (ACV)
  • deterioro cognitivo

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Grupo de Intervención Inmediata
Los participantes ingresarán a un juego en línea y aprenderán cómo prevenir afecciones cardiovasculares y metabólicas.
Para abordar los resultados primarios de viabilidad y aceptabilidad del VE, capturaremos los datos del proceso mediante un entorno virtual basado en computadora y medidas de autoinforme mediante una encuesta en línea.
Otro: Grupo de control de lista de espera
Los participantes ingresarán a un juego en línea en una fecha posterior después del grupo de intervención inmediata y aprenderán cómo prevenir afecciones cardiovasculares y metabólicas.
Para abordar los resultados primarios de viabilidad y aceptabilidad del VE, capturaremos los datos del proceso mediante un entorno virtual basado en computadora y medidas de autoinforme mediante una encuesta en línea.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility of Virtual Environment Intervention
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Body Mass Index (BMI)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de mayo de 2023

Finalización primaria (Actual)

31 de marzo de 2025

Finalización del estudio (Actual)

31 de marzo de 2025

Fechas de registro del estudio

Enviado por primera vez

28 de octubre de 2020

Primero enviado que cumplió con los criterios de control de calidad

7 de febrero de 2022

Publicado por primera vez (Actual)

16 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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