The LEARN Study for CVD Prevention

Not Applicable

Active, not recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: Gaming in a virtual environment

• Registration Number: NCT05242952
• Lead Sponsor: Yale University

Brief Summary

The investigator is testing a virtual environment to address prevention of HIV-related comorbidities.

Detailed Description

The primary aims of this study are to test the feasibility, acceptability and preliminary effects of a VE to address prevention of HIV-related comorbidities. A waitlist control feasibility clinical trial will be conducted. We will assign (N=80) eligible participants and ensure balanced allocation to intervention and control groups over the intervention period. We hypothesize that the VE will be feasible and acceptable to persons living with HIV, and that they will apply their VE learning to real-life situations and health behaviors for prevention of HIV-related comorbidities.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-16
• Study Start: 2023-05-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• identify as an ethnic/racial minority with HIV
• identify as gay, same-gender-loving, or MSM
• able to read and understand English
• access to a computer capable of downloading and running the VE software
• no medical history of serious cardiovascular or cognitive complications

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Exclusion Criteria

Anything outside of inclusion parameters, including history of:

• myocardial infarction (MI)
• congestive heart failure (CHF)
• coronary artery bypass graft (CABG)
• cerebral vascular accident (CVA)
• cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Intervention Group	Gaming in a virtual environment	Participants will enter an online game and learn about how to prevent cardiovascular and metabolic conditions.
Waitlist Control Group	Gaming in a virtual environment	Participants will enter an online game at a later date after the immediate intervention group and learn about how to prevent cardiovascular and metabolic conditions.

Primary Outcome Measures

Name	Time	Method
Acceptability/Feasibility {change over 3 timepoints}	Baseline and Month 3 & 6	Based on Technology Acceptance Model, using the same unit of measure, we will examine Perceived Usefulness (Cronbach's alpha 0.98) and Perceived Ease of Use (Cronbach's alpha 0.94) with an online 7-point Likert scale.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular health {change over 3 timepoints}	Baseline and Month 3 & 6	Life's Simple 7, based on 7 modifiable health behaviors, provides scores (range, 0 to 14) based on smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and fasting glucose. This study will only measure 4 out of the 7: smoking, diet, physical activity, and BMI.
Physical Activity {change over 3 timepoints}	Baseline and Month 3 & 6	International Physical Activity Questionnaire - Short Form will assess intensity of physical activity and sitting time using a 7-item, open-ended measure. Cronbach's alpha 0.80.
Tobacco and E-cigarette use {change over 3 timepoints}	Baseline and Month 3 & 6	BRFSS - self report measure questions that pertain to Tobacco use and E-cigarette use (7 questions). kappa statistic 0.81-0.92.
Food consumption {change over 3 timepoints}	Baseline and Month 3 & 6	Food Frequency Questionnaire - Reports how frequently individuals consume foods in 16 categories. Multifactor Screener has demonstrated correlations of 0.5-0.8 with estimated true intake.
Psychosocial wellbeing {change over 3 timepoints}	Baseline and Month 3 & 6	Patient Health Questionnaire-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.
Illness Perceptions {change over 3 timepoints}	Baseline and Month 3 & 6	The Revised Illness Perception Questionnaire measures illness perceptions about hypertension and type 2 diabetes on a 5-point Likert scale ("strongly disagree" to "strongly agree").

Trial Locations

Locations (1)

Yale University; 🇺🇸 Orange, Connecticut, United States