- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05242952
Исследование LEARN для профилактики сердечно-сосудистых заболеваний (LEARN)
ИСПОЛЬЗОВАНИЕ ВИРТУАЛЬНОЙ СРЕДЫ (LEARN) для улучшения профилактики сопутствующих заболеваний, связанных с ВИЧ, у МСМ из групп риска
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Connecticut
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Orange, Connecticut, Соединенные Штаты, 06477
- Yale University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Описание
Критерии включения:
- идентифицируют себя как этническое/расовое меньшинство с ВИЧ
- идентифицируют себя как геи, представители своего пола или МСМ
- умеет читать и понимать по-английски
- доступ к компьютеру, способному загрузить и запустить программное обеспечение VE
- отсутствие в анамнезе серьезных сердечно-сосудистых или когнитивных осложнений
Критерий исключения:
Все, что не входит в параметры включения, включая историю:
- инфаркт миокарда (ИМ)
- застойная сердечная недостаточность (ЗСН)
- коронарное шунтирование (АКШ)
- нарушение мозгового кровообращения (ЦВС)
- когнитивные нарушения
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Группа немедленного вмешательства
Участники войдут в онлайн-игру и узнают о том, как предотвратить сердечно-сосудистые и метаболические заболевания.
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Чтобы получить основные результаты осуществимости и приемлемости VE, мы будем собирать данные о процессе, используя компьютерную виртуальную среду, и самостоятельно сообщать о мерах, используя онлайн-опрос.
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Другой: Группа управления списком ожидания
Участники войдут в онлайн-игру позже после группы немедленного вмешательства и узнают о том, как предотвратить сердечно-сосудистые и метаболические заболевания.
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Чтобы получить основные результаты осуществимости и приемлемости VE, мы будем собирать данные о процессе, используя компьютерную виртуальную среду, и самостоятельно сообщать о мерах, используя онлайн-опрос.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Feasibility of Virtual Environment Intervention
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Body Mass Index (BMI)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Yale University School of Nursing
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Инфекции, передающиеся через кровь
- Урогенитальные заболевания
- Генитальные заболевания
- Заболевания иммунной системы
- Инфекции
- РНК-вирусные инфекции
- Вирусные заболевания
- Передающиеся заболевания
- Заболевания, передающиеся половым путем, вирусные
- Заболевания, передающиеся половым путем
- Лентивирусные инфекции
- Ретровирусные инфекции
- Синдромы иммунологического дефицита
- Поведение
- Сексуальное поведение
- ВИЧ-инфекции
- Сердечно-сосудистые заболевания
- Коитус
Другие идентификационные номера исследования
- 2000031403
- 1K01HL145580-01A1 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .