Protecting Alzheimer Caregivers Using Technology Through Staying Sharp
NCT ID: NCT05260515
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
138 participants
INTERVENTIONAL
2023-04-30
2024-08-30
Brief Summary
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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.
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Detailed Description
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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.
Aim 3: Establish preliminary efficacy of Staying Sharp intervention. Using unobtrusive home-sensing technologies, twenty newly-recruited caregivers of persons with ADRD will participate in a 4-month intervention with 4 months follow-up. We hypothesize that Staying Sharp will promote physical, mental, and social health for caregivers of persons with ADRD. A non-linear dose-response curve will be used to determine the pre- to post-intervention changes associated with Staying Sharp. This aim involves understanding interventions pointing toward refinement, modification, and adaptation for caregivers and pilot testing.
PROACTS uniquely takes an existing publicly available online health intervention and rapidly tests its efficacy using a home-based, unobtrusive technology platform to provide ecologically valid evidence of how this multi-component intervention may support health in caregivers of persons with ADRD. The PROACTS study will lay the groundwork for later stage (III/IV) effectiveness studies. Future grants (R01/PCORI) will bring together caregivers and health stakeholders to evaluate elements within Staying Sharp for ensuring a high-quality, high-impact, and scalable caregiver intervention.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Staying Sharp intervention
Staying Sharp is an online intervention to promote healthy behaviors through six health pillars (Be social, Engage your brain, Manage stress, Ongoing exercise, Restorative sleep, and Eat right).
Staying Sharp intervention
In the Staying Sharp online program, participants have the opportunity to select which health pillars they are most interested in improving (Be social, Engage your brain, Manage stress, Ongoing exercise, Restorative sleep, and Eat right). After selecting the health pillars, participants can set plans and goals. There are designated activities in each health pillar for participants to complete, including watch videos, read articles, or play games. Participants will follow a step-by-step guide to achieve these goals. The website tracks the status of these goals.
Participants will use Staying Sharp program for 4 months. Research staff will call participants to encourage participants to use the program. Right after the completion of the 4-month program, we will send out a survey to understand user experiences. We will follow participants for another 4 months. After 4 months follow-up, an exit study survey will be conducted either via videoconferences or in-person visits.
Interventions
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Staying Sharp intervention
In the Staying Sharp online program, participants have the opportunity to select which health pillars they are most interested in improving (Be social, Engage your brain, Manage stress, Ongoing exercise, Restorative sleep, and Eat right). After selecting the health pillars, participants can set plans and goals. There are designated activities in each health pillar for participants to complete, including watch videos, read articles, or play games. Participants will follow a step-by-step guide to achieve these goals. The website tracks the status of these goals.
Participants will use Staying Sharp program for 4 months. Research staff will call participants to encourage participants to use the program. Right after the completion of the 4-month program, we will send out a survey to understand user experiences. We will follow participants for another 4 months. After 4 months follow-up, an exit study survey will be conducted either via videoconferences or in-person visits.
Eligibility Criteria
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Inclusion Criteria
* Self-identifying as an unpaid, non-professional caregivers of persons with cognitive impairment (mild cognitive impairment to end-stage dementia)
* 18 years or older
* 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
Exclusion Criteria
* Conditions that would limit participation at entry to study (e.g. visual or hearing impairments prohibiting reading and discussing the survey)
* 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.
18 Years
120 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Oregon Health and Science University
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Kaye, MD
Role: STUDY_DIRECTOR
Oregon Health and Science University
Chao-Yi Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Central Contacts
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Other Identifiers
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