Clinical trial NCT06006962: Aging Well Through Interactions and Scientific Education - Action Plan (AgeWISE-AP)
Official title: Aging Well Through Interactions and Scientific Education - Action Plan (AgeWISE-AP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Aging
Keywords: Cognitive Aging
Lifestyle Risk Reduction
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Boston Healthcare System
First posted: 2023-08-23
Enrollment: 128
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm study: AgeWISE-AP intervention arm and a no treatment waitlist control group arm.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
timeFrame: Baseline
measure: Cognitive Health Questionnaire (CHQ)
timeFrame: Baseline
measure: Health-Promoting Lifestyle Profile II (HPLP II)
timeFrame: Baseline
measure: PROMIS Social Roles and Activities
timeFrame: Baseline
measure: Global Sleep Assessment Questionnaire (GSAQ)
timeFrame: Baseline
measure: General and Memory Specific Control Beliefs Scale
timeFrame: Baseline
measure: Philadelphia Geriatric Center Morale Scale (PGCMS)
timeFrame: Baseline
measure: The NIH Toolbox Meaning and Purpose Short Form
timeFrame: Baseline
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: The Center for Epidemiological Studies-Depression (CES-D)
timeFrame: Baseline
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline
measure: The General Self-Efficacy Scale (GSE)
timeFrame: Baseline
measure: Multifactorial Memory Questionnaire (MMQ)
timeFrame: Baseline
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
measure: Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
timeFrame: 4-months
measure: Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
timeFrame: 8-months
measure: Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
timeFrame: 12-months
measure: Cognitive Health Questionnaire (CHQ)
timeFrame: 4-months
measure: Cognitive Health Questionnaire (CHQ)
timeFrame: 8-months
measure: Cognitive Health Questionnaire (CHQ)
timeFrame: 12-months
measure: Health-Promoting Lifestyle Profile II (HPLP II)
timeFrame: 4-months
measure: Health-Promoting Lifestyle Profile II (HPLP II)
timeFrame: 8-months
measure: Health-Promoting Lifestyle Profile II (HPLP II)
timeFrame: 12-months
measure: PROMIS Social Roles and Activities
timeFrame: 4-months
measure: PROMIS Social Roles and Activities
timeFrame: 8-months
measure: PROMIS Social Roles and Activities
timeFrame: 12-months
measure: Global Sleep Assessment Questionnaire (GSAQ)
timeFrame: 4-months
measure: Global Sleep Assessment Questionnaire (GSAQ)
timeFrame: 8-months
measure: Global Sleep Assessment Questionnaire (GSAQ)
timeFrame: 12-months
measure: General and Memory Specific Control Beliefs Scale
timeFrame: 4-months
measure: General and Memory Specific Control Beliefs Scale
timeFrame: 8-months
measure: General and Memory Specific Control Beliefs Scale
timeFrame: 12-months
measure: Philadelphia Geriatric Center Morale Scale (PGCMS)
timeFrame: 4-months
measure: Philadelphia Geriatric Center Morale Scale (PGCMS)
timeFrame: 8-months
measure: Philadelphia Geriatric Center Morale Scale (PGCMS)
timeFrame: 12-months
measure: The NIH Toolbox Meaning and Purpose Short Form
timeFrame: 4-months
measure: The NIH Toolbox Meaning and Purpose Short Form
timeFrame: 8-months
measure: The NIH Toolbox Meaning and Purpose Short Form
timeFrame: 12-months
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 4-months
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 8-months
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12-months
measure: The Center for Epidemiological Studies-Depression (CES-D)
timeFrame: 4-months
measure: The Center for Epidemiological Studies-Depression (CES-D)
timeFrame: 8-months
measure: The Center for Epidemiological Studies-Depression (CES-D)
timeFrame: 12-months
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: 4-months
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: 8-months
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: 12-months
measure: The General Self-Efficacy Scale (GSE)
timeFrame: 4-months
measure: The General Self-Efficacy Scale (GSE)
timeFrame: 8-months
measure: The General Self-Efficacy Scale (GSE)
timeFrame: 12-months
measure: Multifactorial Memory Questionnaire (MMQ)
timeFrame: 4-months
measure: Multifactorial Memory Questionnaire (MMQ)
timeFrame: 8-months
measure: Multifactorial Memory Questionnaire (MMQ)
timeFrame: 12-months
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: 4-months
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: 8-months
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Maureen O'Connor, PsyD
role: PRINCIPAL_INVESTIGATOR
References: