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Набор скоро начнётся NCT05811338

Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 1

Без фазы С лечением Mild Cognitive Impairment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Center for Research and Education on Aging and Technology Enhancement - CREATE V

Обзор

Project 1: The goal of this research project is to examine usability and acceptance of virtual reality (VR) applications and their efficacy with older adults. This highly innovative cross-site Stage 1 Intervention Development Project (NIH (National Institutes of Health) Stage Model) will apply the CREATE systematic approach to the design and evaluation of an immersive VR program, Cognitive Activity Social Technology (CAST), for older adults. The program will provide a suite of virtual cognitive, social and activity engagement applications; and allow for virtual interactions.

Подробное описание

Deployment of technology in healthcare and day-to- day activities is increasing and advances in technology such as artificial intelligence (AI) are increasingly aimed at supporting older adults. Yet, aging adults are often ignored in design, and robust research evaluating the usability, safety, and efficacy of these systems with older adults is limited. Even among older technology adopters, rapid changes in technology pose challenges in terms of the constant need for adaptation and continual learning. Further, there remains a lag in uptake among many older adult sub-groups, including ethnic minorities, older cohorts, those of lower socio-economic status, those living in a rural location, or with a cognitive impairment such as Mild Cognitive Impairment (MCI) or Alzheimer's Disease/Alzheimer's Disease Related Dementias (AD/ADRD). The goal of CREATE V is to harness the potential benefits and power of technology to maintain, support, and foster the cognitive, emotional, and physical health of aging adults to enhance independence, well-being, and quality of life. Given that age represents a significant risk factor for cognitive impairments such as MCI and AD/ADRD, and the criticality of cognition to everyday functioning, a thrust of the research investigators planned research is on using emerging technologies to help maintain cognitive health and provide support for those with cognitive impairments. CREATE V has a fresh vision, a focus on emerging technologies, expanded research teams, new populations such as those with cognitive impairments, and technological capabilities.

Project 1: Phase 1, akin to NIH Stage 1a, will involve usability testing across the three CREATE sites with older adults, and heuristic analysis to gather information on user preferences, usability problems, implementation, and training protocols.

Phase 2, akin to NIH Stage 1b, will involve a cross-site pilot randomized trial with a large and diverse sample of aging adults. Participants will be randomized, following a baseline assessment, to the VR CAST condition or a tablet control condition, where participants will be exposed to similar context in 2d (e.g., online museum tours). Following training on the VR program/tablet, they will use the VR program/tablet in their home for two months. The battery of measures will be re-administered at 1 and 2-months post randomization. Research investigators will collect real time data on use of the VR program/tablet. The planned project will yield significant and timely information on the feasibility of using VR support for older adults, delineate potential mediator and moderators of the benefits of VR, and design guidelines for VR interventions for older adults.

Projects 2 and 3 under this grant were originally registered as part of this ClinicalTrials.gov record (NCT05811338), but have since been separated into their own respective ClinicalTrials.gov records.

Вмешательства

  • Поведенческое Project 1, Phase 2: VR Program for Social, Activity, and Cognitive Engagement
    The investigators will apply a systematic approach to the design and evaluation of an immersive Cognitive Activity Social Technology (CAST) VR intervention (using the Oculus Quest 2), that provides aging adults a suite of virtual cognitive, social, and activity engagement applications. The program will allow for virtual interactions (one-on one or groups), cultural, creativity, and educational opportunities, and gaming.

Первичные конечные точки

  • Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of days used [Срок оценки: Baseline through 2 months]
  • Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of times used per day [Срок оценки: Baseline through 2 months]
  • Project 1, Phase 2: Perceived System Feasibility of the CAST Program as measured by the number of features used per day [Срок оценки: Baseline through 2 months]
  • Project 1, Phase 2: Mean Difference of Perceived Ease of Use of the CAST Program Assessed using the Perceived Ease of Use Questionnaire [Срок оценки: Post-Randomization at Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference of Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire [Срок оценки: Post-Randomization at Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference in Score of CAST Program Intervention Workload, assessed using the NASA Tax Load Index (TLX) Measure [Срок оценки: Post-Randomization at Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference in Score of Perceived CAST Program system enjoyment Assessed using The User Experience Questionnaire [Срок оценки: Post-Randomization at Month 1 and Month 2]
Вторичные конечные точки (4)
  • Project 1, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure [Срок оценки: Post-Randomization at Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire [Срок оценки: Post-Randomization at the Baseline assessment, Month 1 and Month 2]
  • Project 1, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale [Срок оценки: Post randomization at the baseline assessment, month 1 and month 2.]
  • Project 1, Phase 2: Mean Difference in score of participants self-reported health, assessed using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form) [Срок оценки: Post randomization at the baseline assessment, month 1 and month 2.]

Критерии участия

Критерии включения

  • 65+ years of age
  • Able to read English at the 6th grade level
  • Have 20/60 vision with or without correction.

Критерии исключения

  • Blind or have visual impairments that limit their ability to view the technology.
  • Deaf or have hearing impairments that limit their ability to answer telephone queries.
  • Have a life-limiting/terminal illness
  • Severe motor impairment (e.g., severe tremors or debilitating arthritis in their hands) that impairs ability to speak or use dominant hand
  • Chronic neck pain/injury that might make the headset uncomfortable

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • Florida State University — Tallahassee
  • University of Illinois Urbana-Champaign — Champaign
  • Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT05811338 · 23-01025559-01 · P01AG073090-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗