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Набор скоро начнётся NCT07485712

Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2

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 2, Phase 2: Intelligent Adaptive System.
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

The goal of this Stage 1 (NIH Stage Model) Intervention Development cross-site project is to develop, using a user-centered design approach, and evaluate an innovative intelligent adaptive software package aimed at providing cognitive and social support and engagement to older adults with mild cognitive impairment (MCI). The system will be designed to adapt to the needs and abilities of the user. The investigator's goal is to develop a unique and highly innovative technology tool that can provide adaptive support to aging individuals with MCI, even as cognition might deteriorate further. Speech data collected as part of an embedded reminiscence feature will advance fundamental knowledge of how speech and language production data might serve as an early indicator of cognitive decline.

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 2: Phase 1 of the project will yield important information on the feasibility of using technology-based approaches to support everyday activities and cognition for persons with MCI and insight on barriers to the implementation of technology-based interventions. The investigators will also gain understanding of the challenges aging adults with MCI encounter in everyday activities.

In phase 2, akin to Stage 1b, the study will involve pilot testing to evaluate the feasibility, acceptability, and usability of the system (primary outcomes) with a diverse sample of individuals with MCI at each site. Investigators will gather preliminary data on efficacy of the system with respect to secondary outcomes such as cognition, perceptions of memory functioning, social connectivity, social support, loneliness, technology proficiency, and the performance of everyday tasks. Investigators will collect real time data on system use and system adaptations. Investigators will examine potential negative consequences of use of the system, such as decreases in social networks or interactions or negative changes in life space. All assessments will occur in the participants' living environment by trained research assistants. An assessor other than the one who conducted the baseline assessment, will conduct follow-up assessments to minimize bias (i.e., assessors will be blinded to treatment condition).

Project 2 record was originally listed under NCT05811338.

Вмешательства

  • Поведенческое Project 2, Phase 2: Intelligent Adaptive System
    An innovative intelligent adaptive software package aimed at providing social and cognitive support to older adults with MCI. The system will be designed to adapt to the needs and abilities of the user.

Первичные конечные точки

  • Project 2, Phase 2: Perceived System Usability of the CAST Program as Measured by the number of times used per day [Срок оценки: Baseline through 6 months]
  • Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of times the system was used per day [Срок оценки: Baseline through 6 months]
  • Project 2, Phase 2: Perceived System Usability of the CAST Program as measured by the number of features used per day [Срок оценки: Baseline through 6 months]
  • Project 2, Phase 2: Perceived Ease of Use of the CAST Program, assessed using the Perceived Ease of Use Questionnaire [Срок оценки: 6 months post intervention]
  • Project 2, Phase 2: Perceived System Usefulness of the CAST Program, assessed using the Perceived Usefulness Questionnaire [Срок оценки: 6-months post intervention]
  • Project 2, Phase 2: Mean scores of participants' perception of CAST program usability and usefulness, assessed using the Usability Metric for user Experience (UMUX-Lite) questionnaire [Срок оценки: 6-months post intervention]
Вторичные конечные точки (5)
  • Project 2, Phase 2: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure [Срок оценки: Baseline and 6 month post intervention]
  • Project 2, Phase 2: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire [Срок оценки: Baseline and 6 month post intervention]
  • Project 2, Phase 2: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale [Срок оценки: Baseline and 6 month post intervention]
  • Project 2, 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: Baseline and 6 month post intervention]
  • Project 2, Phase 2: Mean Difference in scores of participants' perceived memory function, assessed using the Perception of Memory Function questionnaire [Срок оценки: Baseline and 6 month post intervention]

Критерии участия

Критерии включения

  • 62+ years of age
  • Able to read English at the 6th grade level
  • Have 20/60 vision with or without correction.
  • Clinical diagnosis of mild cognitive impairment (MCI)
  • Subjective cognitive complaints
  • Evidence by clinical evaluation
  • Clinical Dementia Rating Global scale of 0.5-2.0
  • Probable MCI
  • Montreal Cognitive Assessment (MoCA) score of 18-26
  • No major Instrumental activities of daily living (IADL) impairments
  • Geriatric Depression Scale of 4 or Below
  • No diagnosis of dementia

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
  • Cognitive impairment (MOCA ≤ 25)

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: NCT07485712 · 23-01025559-02 · P01AG073090-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗