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临床试验/NCT04626804
NCT04626804已完成不适用

Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community

Indiana University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Usability

研究概览

简要总结

Test the usability, perceptions and acceptability of a computer monitor for participant diagnosed with ADRD and their caregiver who will program the applications specifically for each individual to help them remember activities of daily living. Goal is to keep participants in their homes longer and delay the need for institutional care

详细描述

Dyads will use the R/S unit for 90 days, unless they request it to be removed prior to the end of the study. The research team (N. Fowler, PhD) will assess measures at baseline, 30 days, 60 days and 90 days. The primary outcome is a caregiver-assessed measure usability. Secondary measures include patient- assessed usability, and objective measures of frequency and type of use and computer literacy for both caregiver and the individual with ADRD22. Methods to collect user data (frequency, clicks, etc.) will be collected using tools developed in Aim 2. Desired outcome measures include (1) a mean score of >80 ("Good") on the ten-item System Usability Scale (SUS) modified by IU investigators to accommodate older adults23; (2) a 80 percent acceptability rate on the Behavioral Intention 3-item scale; and, (3) at least 70 percent of participants using R/S a minimum of weekly. SUS is a validated ten-item scale (e.g., "Learning to use RememberStuff® was quick for me") using a five-point response scale (strongly disagree to strongly agree). Acceptance will be assessed as the mean score on a 3-item Satisfaction scale (e.g., "Rate your satisfied with RememberStuff®?"). This scale was adapted by IU Investigators for health IT and uses a seven-point response scale from 0 (not at all) to 6 (a great deal). Satisfaction is one of the canonical assessments for user acceptance of technology. SUS and Satisfaction questionnaires will be researcher-administered by study staff either face-to-face in the participant's homes, or via telephone. The mean and standard deviation for the composite SUS, acceptability rate and weekly usage will be calculated to a 90% confidence interval. Other secondary measures are adapted from Holden et al and are guided by the UTAUT221. Mean caregiver scores on the measures will also be compared to mean scores of the patient measures to examine congruence in usability and acceptability within the dyad.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • achieve a Montreal Cognitive Assessment (MoCA) score of 6-17 (mild to moderate dementia)
  • diagnosis of early Alzheimer's disease or related dementia or caregiver reports ADRD diagnosis (if community based recruitment)
  • provide identification of a caregiver (living with or otherwise involved in the ongoing care of the person with ADRD)
  • able to communicate in English
  • able to provide informed consent

排除标准

  • lives in a nursing home or long term care facility or assisted living facility
  • do not pass the MoCA with a score between 6-17
  • unable to identify a caregiver
  • is limited by severe arthritis or other condition in the use of his/her hands
  • Caregiver Inclusion Criteria:
  • 21 years or older
  • able to provide informed consent
  • able to communicate in English
  • Caregiver Exclusion Criteria:
  • under 21 years of age
  • does not have access to a computer/device
  • diagnosis of ADRD
  • diagnosis of serious mental illness (i.e. schizophrenia)

结局指标

主要结局

Usability

时间窗: through study completion, an average of 4 months

Satisfaction and use of the monitor and apps using the Usability Scale, a validated 10-item scale sithe items suchs as "learning to use the calendar function was quick for me", using a 5 point response scale (0= strongly disagree to 5= strongly agree) Usability Scale, a validated 10-item scale (e.g. "Learning to use Calendar function was quick for me" using a 5-point response scale (0=strongly disagree to 5= strongly agree)

次要结局

  • Intention of Use(through study completion, an average of 4 months)
  • Acceptability(through study completion, an average of 4 months)
  • Performance expectancy(through study completion, an average of 4 months)
  • Computer literacy(through study completion, an average of 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole R. Fowler, PhD

Associate Professor of Medicine

Indiana University

研究点 (2)

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