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

NCT ID: NCT06006962

Last Updated: 2025-11-10

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Aging

Keywords

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Cognitive Aging Lifestyle Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm study: AgeWISE-AP intervention arm and a no treatment waitlist control group arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Receiving intervention - AgeWISE-AP

Group Type EXPERIMENTAL

Aging Well through Interactions and Scientific Education - Action Plan

Intervention Type OTHER

20-week program designed to provide education and individualized planning with a goal of improving brain health.

Waitlist Control

No intervention; will be invited to participate in intervention after completion of study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aging Well through Interactions and Scientific Education - Action Plan

20-week program designed to provide education and individualized planning with a goal of improving brain health.

Intervention Type OTHER

Other Intervention Names

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AgeWISE-AP

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Boston Healthcare System

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maureen O'Connor, PsyD

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Locations

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VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrew H Nguyen, MA

Role: CONTACT

Phone: (781) 825-3123

Email: [email protected]

Facility Contacts

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Andrew H Nguyen, MA

Role: primary

Other Identifiers

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I01RX004828

Identifier Type: NIH

Identifier Source: secondary_id

View Link

E4828-R

Identifier Type: -

Identifier Source: org_study_id