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Mild Cognitive ImpairmentPhase 1/2PROACTSNCT05260515

Protecting Alzheimer Caregivers Using Technology Through Staying Sharp

A Phase 1/2 study testing Staying Sharp intervention in people with Mild Cognitive Impairment and Dementia Alzheimers, run by Oregon Health and Science University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 yearsHealthy volunteers can take part
What is being tested?
Staying Sharp intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
No sites listed yet
Study dates
30 Apr 2023to 30 Aug 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Aim 1\&2 Inclusion Criteria:

  • 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

Aim 1\&2 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 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.

Trial locations and contacts

No sites are listed yet.

Chao-Yi Wu, PhD contact

4124943978

wucha@ohsu.edu

About this study

Official title: Protecting Alzheimer Caregivers Using Technology Through Staying Sharp (PROACTS)

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.

Read the detailed description

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.

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.

Being tested
Staying Sharp intervention
Keywords
technology, online intervention, intervention efficacy, user experience, user adherence, remote monitoring, online platform, digital biomarker
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease, Caregiver Burden, Health Behavior, Social Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Staying Sharp interventionBehavioural

    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.

Study groups in NCT05260515
Study groupRoleWhat they receive
Staying Sharp interventionExperimentalStaying 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).
Receives: Behavioral: Staying Sharp intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. User experience

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

    Measured: Baseline

  2. Physical activity

    Physical activity will be assessed using an Actigraphy smartwatch.

    Measured: Change from baseline physical activity at 4 months

  3. Socialization

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

    Measured: Change from baseline socialization score at 4 months

  4. Cognition

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

    Measured: Change from baseline cognition at 4 months

  5. Caregiver Burden

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

    Measured: Change from baseline caregiver burden at 4 months

  6. Sleep Health

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

    Measured: Change from baseline sleep health at 4 months

  7. Dietary behaviors

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

    Measured: Change from baseline dietary behaviors at 4 months

Secondary outcomes (1)

  1. Online engagement

    Activities engaged in the Staying Sharp will be examined (e.g., read articles, watch videos).

    Measured: Change from baseline engagement score at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start30 Apr 2023 (estimated)
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05260515
Sponsor's protocol ID
P30AG024978
Other IDs
5P30AG024978-18
Acronym
PROACTS
Status last verified
Feb 2023
First submitted
7 Feb 2022
Last updated
9 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD (without identifiable data) and all IPD that underlie results in a publication could be provided upon request.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Staying Sharp intervention in people with Mild Cognitive Impairment and Dementia Alzheimers, run by Oregon Health and Science University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chao-Yi Wu, PhD (4124943978, wucha@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

User experience (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05260515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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