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Aging Well Through Interactions and Scientific Education - Action Plan (AgeWISE-AP)

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VA Office of Research and Development

Status

Enrolling

Conditions

Cognitive Aging

Treatments

Other: Aging Well through Interactions and Scientific Education - Action Plan

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06006962
E4828-R
I01RX004828 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to learn about the effects of AgeWISE-Action Plan (AgeWISE-AP), a 20-week program designed to provide education and individualized planning with a goal of improving brain health.

Full description

The overall goal of this proposal is to conduct a fully powered randomized controlled trial of a multi-component intervention designed to provide education about brain aging, improve feelings of control over brain aging, and deliver practical assistance with creation of an executable action plan (AgeWISE-Action Plan). The AgeWISE-Action Plan (AgeWISE-AP) is intended to extend our prior AgeWISE program by adding an individualized action plan component to increase older Veteran engagement in brain healthy lifestyle activities.

AIM 1 (primary): To determine whether AgeWISE-AP increases older Veterans' engagement in lifestyle factors that promote brain health. AgeWISE provides information about the differences between normal and diseased brain aging and lifestyle factors that contribute to brain health. The action plan (AP) component will use this foundation to collaboratively create an individualized brain health plan to increase Veteran engagement in brain healthy lifestyle activities. H1. AgeWISE-AP participants will demonstrate increased engagement in brain-healthy lifestyle activities compared to the control group.

AIM 2 (primary): To determine whether AgeWISE-AP improves psychological wellness. AgeWISE provides information about the relationship between cognitive aging and affective states (e.g., depression) and attitudes about aging, and teaches stress reduction techniques. The action plan (AP) will provide additional individualized supports to improve psychological well-being with personalized goals and lifestyle modifications (e.g., diet, exercise, sleep, cognitive stimulation). H2. AgeWISE-AP participants will show increases in perception of control over cognitive aging, meaning and purpose in life, quality of life, and self-efficacy, as well as improved attitudes toward aging and decreased loneliness, depression, and anxiety compared to the control group.

AIM 3 (primary): To determine whether AgeWISE-AP improves cognition. Cognitive strategies to improve cognition and functioning are presented and practiced over three AgeWISE sessions, with homework to improve generalization to day-to-day life. Engagement in brain-healthy lifestyle activities will be accomplished through the action plan (AP). H3. Self-reported memory contentment, ability, and compensatory strategy use will increase and objective cognitive testing will be better for AgeWISE-AP participants compared to the control group.

Aim 4 (exploratory): To determine whether AgeWISE-AP influences biomarkers of brain health using structural neuroimaging methods. H4. At one-year follow-up AgeWISE-AP participants will have less volumetric decline in dementia-related brain regions compared to the control group.

Enrollment

128 estimated patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Veterans > 60 years old with concerns about brain aging who want to learn more about cognitive aging
  • English speaking as all intervention materials are written in English

Exclusion criteria

  • Veterans with impairment on a cognitive screening measure, as determined using a MoCA cutoff score for dementia of <24 OR self or other reported diagnosis of a brain disorder affecting cognition such as Alzheimer's disease, Parkinson's disease, other dementia, major stroke, or brain injury or diagnosis of psychotic disorder such as schizophrenia
  • Active alcohol or substance abuse

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

128 participants in 2 patient groups

Intervention
Experimental group
Description:
Receiving intervention - AgeWISE-AP
Treatment:
Other: Aging Well through Interactions and Scientific Education - Action Plan
Waitlist Control
No Intervention group
Description:
No intervention; will be invited to participate in intervention after completion of study.

Trial contacts and locations

1

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Central trial contact

Andrew H Nguyen, MA

Data sourced from clinicaltrials.gov

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