Clinical trial NCT05260515: Protecting Alzheimer Caregivers Using Technology Through Staying Sharp
Official title: Protecting Alzheimer Caregivers Using Technology Through Staying Sharp (PROACTS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Mild Cognitive Impairment
Dementia Alzheimers
Old Age; Dementia
Caregiver Burden
Health Behavior
Social Behavior
Caregiver Burnout
Keywords: technology
online intervention
intervention efficacy
user experience
user adherence
remote monitoring
online platform
digital biomarker
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-03-02
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: User experience
timeFrame: Baseline
measure: Physical activity
timeFrame: Change from baseline physical activity at 4 months
measure: Socialization
timeFrame: Change from baseline socialization score at 4 months
measure: Cognition
timeFrame: Change from baseline cognition at 4 months
measure: Caregiver Burden
timeFrame: Change from baseline caregiver burden at 4 months
measure: Sleep Health
timeFrame: Change from baseline sleep health at 4 months
measure: Dietary behaviors
timeFrame: Change from baseline dietary behaviors at 4 months
Secondary outcomes:
measure: Online engagement
timeFrame: Change from baseline engagement score at 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Jeffrey Kaye, MD
role: STUDY_DIRECTOR
affiliation: Oregon Health and Science University
name: Chao-Yi Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: