- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05242952
CVD 예방을 위한 LEARN 연구 (LEARN)
위험에 처한 소수 MSM에서 HIV 관련 합병증 예방을 강화하기 위한 가상 환경(LEARN) 활용
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Connecticut
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Orange, Connecticut, 미국, 06477
- Yale University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- HIV에 걸린 소수 민족/인종으로 식별
- 동성애자, 동성애자 또는 MSM으로 식별
- 영어를 읽고 이해할 수 있는
- VE 소프트웨어를 다운로드하고 실행할 수 있는 컴퓨터에 대한 액세스
- 심각한 심혈관 또는 인지 합병증의 병력 없음
제외 기준:
다음 기록을 포함하여 포함 매개변수 외부의 모든 것:
- 심근경색(MI)
- 울혈성 심부전(CHF)
- 관상동맥우회술(CABG)
- 뇌혈관 사고(CVA)
- 인지 장애
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 즉각적인 개입 그룹
참가자들은 온라인 게임에 참가하여 심혈관 및 대사 질환을 예방하는 방법에 대해 배우게 됩니다.
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VE의 타당성 및 수용 가능성의 주요 결과를 다루기 위해 컴퓨터 기반 가상 환경을 사용하여 프로세스 데이터를 캡처하고 온라인 설문 조사를 사용하여 자체 보고 측정을 수행합니다.
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다른: 대기자 명단 제어 그룹
참가자들은 즉각적인 개입 그룹이 끝난 후 추후 온라인 게임에 참가하여 심혈관 및 대사 질환을 예방하는 방법에 대해 배우게 됩니다.
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VE의 타당성 및 수용 가능성의 주요 결과를 다루기 위해 컴퓨터 기반 가상 환경을 사용하여 프로세스 데이터를 캡처하고 온라인 설문 조사를 사용하여 자체 보고 측정을 수행합니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of Virtual Environment Intervention
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Body Mass Index (BMI)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Yale University School of Nursing
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2000031403
- 1K01HL145580-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .