跳至主要内容
临床试验/NCT05260515
NCT05260515尚未招募1 期

Protecting Alzheimer Caregivers Using Technology Through Staying Sharp (PROACTS)

Oregon Health and Science University0 个研究点目标入组 138 人开始时间: 2023年4月30日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
138
主要终点
Physical activity

研究概览

简要总结

PROACTS is a Phase I/II study to assess the efficacy of AARP Staying Sharp online health program, focusing on the health of non-professional home-based caregivers of persons with Alzheimer's disease and related dementias (ADRD). PROACTS has three aims. Aim 1&2 is an one-time survey study to evaluate the current uptake and utilization of Staying Sharp among caregivers. Aim 3 is a single-group intervention to assess how Staying Sharp may maintain health and function for caregivers of persons with ADRD. Participants will participate in a 4-month program with a 4-month follow-up.

Aim 1&2: Characterize caregivers of persons with ADRD using Staying Sharp and evaluate user experiences of Staying Sharp.

Aim 3: Establish preliminary efficacy of Staying Sharp program.

详细描述

Significance: Approximately 16 million adults provide unpaid care to their loved ones with Alzheimer's disease and related disorders (ADRD). Among caregivers, 1 in 3 are older adults. For these caregivers, balancing their own health while caring for loved ones can be stressful, depressing, and feelings of hopelessness. This long-term distress can lead to higher risks of cardiovascular diseases, dementia, and mortality. Given the rise of incident dementia and caregiving, scalable interventions to support family caregivers are urgently needed.

Intervention: Staying Sharp is an online brain health intervention for older adults available through AARP since 2018. Over 400,000 AARP members have registered for this online intervention. This multi-component intervention includes a package of assessments, brain games, and educational videos and articles to maintain 6-pillars healthy behaviors. Independent of Staying Sharp, over 39 million have visited AARP's online caregiving resource center. The large number of visits not only shows high demand for caregiver support, but reveals the potential of Staying Sharp to reach tens of thousands of caregivers at greater risk by their role for increased morbidity and mortality.

Stage I/II user experience and efficacy study: While many users have registered for Staying Sharp, its efficacy has not been tested. Home-sensing technology is an ecologically valid way of testing the efficacy of health interventions. The Oregon Center of Aging & Technology (ORCATECH) has established a home-based, technology-agnostic, unobtrusive platform for more than 15 years. With this platform, we will assess how Staying Sharp may maintain brain health and function as indicated by a suite of digital biomarkers (e.g., physical activity, sleep, dietary behaviors). Our ultimate goal is to refine Staying Sharp by examining user experience and intervention efficacy and ultimately scale the program widely. To achieve this goal, we are collaborating with AARP. The Specific Aims of the study are to:

Aim 1: Characterize caregivers of persons with ADRD using Staying Sharp. We will send out a survey to registrants of Staying Sharp. We hypothesize that caregiver users are younger, predominantly women, with higher stress, and less social support than non-caregiver users. This aim will clarify the demographics and basic health conditions of caregivers who have been utilizing this online health intervention.

Aim 2: Evaluate user experiences of Staying Sharp. We will use the same survey in aim 1 to assess user experiences with a focus on the profile of sustainable use characteristics. We hypothesize caregiver users will spend more time on stress and exercise pillars than non-caregiver users. This aim will evaluate the engagement and uptake of Staying Sharp among dementia caregivers.

研究设计

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

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current AARP Staying Sharp registrants
  • Self-identifying as an unpaid, non-professional caregivers of persons with cognitive impairment (mild cognitive impairment to end-stage dementia)
  • 18 years or older

排除标准

  • Inability to speak English or read printed materials in English
  • Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the survey)
  • Aim 3 Inclusion Criteria:
  • Self-identifying as an unpaid, non-professional caregivers of persons with mild cognitive impairment (MCI) or end-stage dementia
  • Have a desktop or a tablet
  • Have reliable broadband internet and are email users
  • Have no experiences using AARP Staying Sharp online health program
  • Home is larger than a studio apartment (important for sensor data)
  • 18 years or older
  • Aim 3 Exclusion Criteria:
  • Inability to speak English or read printed materials in English
  • Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the program and assessments)
  • Any uncontrolled medical condition that is expected to preclude completion of the study, such as late stage cancers.

结局指标

主要结局

Physical activity

时间窗: Change from baseline physical activity at 4 months

Physical activity will be assessed using an Actigraphy smartwatch.

User experience

时间窗: Baseline

User experiences of the Staying Sharp will be assessed using an user experience survey.

Socialization

时间窗: Change from baseline socialization score at 4 months

Socialization will be assessed using the passive infrared motion sensors installed on the front door to detect time out of the house.

Cognition

时间窗: Change from baseline cognition at 4 months

Everyday cognition will be assessed using commercial software (WorkTime; Toronto, Canada) installed on participants' desktops to collect time spent on the computers.

Dietary behaviors

时间窗: Change from baseline dietary behaviors at 4 months

Dietary behaviors will be assessed using an online survey modified from the Food Frequency Questionnaire (FFQ).

Sleep Health

时间窗: Change from baseline sleep health at 4 months

Sleep health will be assessed using a bed mat installed under participants' bed.

Caregiver Burden

时间窗: Change from baseline caregiver burden at 4 months

Caregiver burden will be assessed via a weekly online survey using the Zarit Burden Interview short form.

次要结局

  • Online engagement(Change from baseline engagement score at 4 months)

研究者

申办方类型
Other
责任方
Sponsor

相似试验