Protecting Alzheimer Caregivers Using Technology Through Staying Sharp

NCT05260515 | Unknown Phase 1

• 2 other identifiers: P30AG0249785P30AG024978-18
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (7)

• User experience

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

  Baseline

• Physical activity

  Physical activity will be assessed using an Actigraphy smartwatch.

  Change from baseline physical activity at 4 months

• Socialization

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

  Change from baseline socialization score at 4 months

• Cognition

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

  Change from baseline cognition at 4 months

• Caregiver Burden

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

  Change from baseline caregiver burden at 4 months

• Sleep Health

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

  Change from baseline sleep health at 4 months

• Dietary behaviors

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

  Change from baseline dietary behaviors at 4 months

Secondary Outcomes (1)

• Online engagement

  Change from baseline engagement score at 4 months

Study Arms (1)

Staying Sharp intervention

EXPERIMENTAL

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).

Behavioral: Staying Sharp intervention

Interventions

Staying Sharp intervention BEHAVIORAL

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.

Staying Sharp intervention

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years or older

You may not qualify if:

• 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)
• 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)
• years or older
• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Caregiver Burden; Health Behavior; Social Behavior

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Jeffrey Kaye, MD

  Oregon Health and Science University

  STUDY DIRECTOR

• Chao-Yi Wu, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Yi Wu, PhD

CONTACT

4124943978; wucha@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 2, 2022
• Study Start: April 30, 2023
• Primary Completion: April 30, 2024
• Study Completion: August 30, 2024
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After study results are published.
• Access Criteria: Upon request