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

NCT06006962 | Recruiting

• 2 other identifiers: E4828-RI01RX004828
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Aging

Keywords

Cognitive Aging; Lifestyle Risk Reduction

Outcome Measures

Primary Outcomes (56)

• Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)

  Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS) is a 41-item scale that explores the frequency and duration of light, moderate, and vigorous physical activities assessed using weekly frequency and duration.

  Baseline

• Cognitive Health Questionnaire (CHQ)

  17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.

  Baseline

• Health-Promoting Lifestyle Profile II (HPLP II)

  A 52-item questionnaire composed of six subscales including health responsibility, nutrition, physical activity, stress management, interpersonal relations, and spiritual growth. Response options are provided on a 4-point Likert scale. Subscale scores are calculated by obtaining a mean score with higher scores indicating, better outcomes.

  Baseline

• PROMIS Social Roles and Activities

  8 items assessing satisfaction with performing one's usual social roles and activities with response options provided on a 5-point Likert scale. A higher score represents better ability to participate or more satisfaction.

  Baseline

• Global Sleep Assessment Questionnaire (GSAQ)

  11 items covering mood, life activities, and medical issues as they relate to sleep and symptoms associated with disorders of sleep. Response options are provided on a 4-point Likert scale with lower scores indicating better outcomes.

  Baseline

• General and Memory Specific Control Beliefs Scale

  Used to measure perceived control over cognitive health. The scale is composed of two sets of items focusing on general and memory-specific control beliefs. We are interested in examining changes in memory-specific control beliefs, which include 4 items with 3 answer choices.

  Baseline

• Philadelphia Geriatric Center Morale Scale (PGCMS)

  17 item scale measuring dimensions of emotional adjustments in persons aged 70 to 90. It provides a multidimensional approach to assessing the state of psychological wellbeing and perceived morale using three factors: agitation, attitude toward own aging and lonely satisfaction. Total score ranges from 0-17 with higher scores indicating higher morality.

  Baseline

• The NIH Toolbox Meaning and Purpose Short Form

  8-item, form that assesses the degree to which participants feel their lives matter/make sense. Each item is rated on a 5-point Likert scale with responses ranging from "strongly disagree" to "strongly agree" and from "not at all" to "very much." Total score ranges from 8-40 with higher scores indicating better outcomes.

  Baseline

• The Patient Health Questionnaire-9 (PHQ-9)

  Reliable and valid (in a variety of patient populations) multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Response options are provided on a 4-point Likert scale, with total score ranging from 1-27. Lower scores indicate better outcomes.

  Baseline

• The Center for Epidemiological Studies-Depression (CES-D)

  20-item measure that rates how often over the past week respondents have experienced depressive symptoms. Response options are provided on a 4-point Likert scale with total scores ranging from 0-60. Lower scores indicate lower depressive symptoms.

  Baseline

• The State-Trait Anxiety Inventory (STAI)

  Commonly used measure of anxiety with 40 total items. Response options are provided on a 4-point Likert scale. Total score range from 40-160 with lower scores indicating lower anxiety.

  Baseline

• The General Self-Efficacy Scale (GSE)

  10-item psychometric scale that assesses optimistic self-beliefs to cope with a variety of difficult demands in life. Response options are provided on a 4-point Likert scale with total score ranging from 10-40. Higher total score indicates better outcomes.

  Baseline

• Multifactorial Memory Questionnaire (MMQ)

  A measure constructed to reflect aspects of memory that are potentially amenable to clinical intervention. The Contentment subscale contains 18 statements that assess emotions and perceptions about current memory ability including anxiety, embarrassment, and irritability. The Ability subscale contains 20 items phrased as memory failures in everyday memory situations (e.g., forgetting an appointment). The Strategy subscale measures self-reported cognitive strategy use. Response options are provided on a 5-point Likert scale. Total score ranges from 0-80 with higher scores indicating better outcomes.

  Baseline

• The Montreal Cognitive Assessment (MoCA)

  Screening instrument that assesses multiple cognitive domains with total score ranging from 0 to 30 points, and a cut score of 24 has demonstrated very good specificity (by correctly identifying 87% of healthy participants) and excellent sensitivity when differentiating MCI (90%) and Alzheimer disease (100%) from healthy comparisons. Total score ranges from 0-30 with higher score indicating better outcomes.

  Baseline

• Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)

  Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS) is a 41-item scale that explores the frequency and duration of light, moderate, and vigorous physical activities assessed using weekly frequency and duration.

  4-months

• Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)

  Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS) is a 41-item scale that explores the frequency and duration of light, moderate, and vigorous physical activities assessed using weekly frequency and duration.

  8-months

• Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)

  Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS) is a 41-item scale that explores the frequency and duration of light, moderate, and vigorous physical activities assessed using weekly frequency and duration.

  12-months

• Cognitive Health Questionnaire (CHQ)

  17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.

  4-months

• Cognitive Health Questionnaire (CHQ)

  17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.

  8-months

• Cognitive Health Questionnaire (CHQ)

  17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.

  12-months

• Health-Promoting Lifestyle Profile II (HPLP II)

  A 52-item questionnaire composed of six subscales including health responsibility, nutrition, physical activity, stress management, interpersonal relations, and spiritual growth. Response options are provided on a 4-point Likert scale. Subscale scores are calculated by obtaining a mean score with higher scores indicating, better outcomes.

  4-months

• Health-Promoting Lifestyle Profile II (HPLP II)

  A 52-item questionnaire composed of six subscales including health responsibility, nutrition, physical activity, stress management, interpersonal relations, and spiritual growth. Response options are provided on a 4-point Likert scale. Subscale scores are calculated by obtaining a mean score with higher scores indicating, better outcomes.

  8-months

• Health-Promoting Lifestyle Profile II (HPLP II)

  A 52-item questionnaire composed of six subscales including health responsibility, nutrition, physical activity, stress management, interpersonal relations, and spiritual growth. Response options are provided on a 4-point Likert scale. Subscale scores are calculated by obtaining a mean score with higher scores indicating, better outcomes.

  12-months

• PROMIS Social Roles and Activities

  8 items assessing satisfaction with performing one's usual social roles and activities with response options provided on a 5-point Likert scale. A higher score represents better ability to participate or more satisfaction.

  4-months

• PROMIS Social Roles and Activities

  8 items assessing satisfaction with performing one's usual social roles and activities with response options provided on a 5-point Likert scale. A higher score represents better ability to participate or more satisfaction.

  8-months

• PROMIS Social Roles and Activities

  8 items assessing satisfaction with performing one's usual social roles and activities with response options provided on a 5-point Likert scale. A higher score represents better ability to participate or more satisfaction.

  12-months

• Global Sleep Assessment Questionnaire (GSAQ)

  11 items covering mood, life activities, and medical issues as they relate to sleep and symptoms associated with disorders of sleep. Response options are provided on a 4-point Likert scale with lower scores indicating better outcomes.

  4-months

• Global Sleep Assessment Questionnaire (GSAQ)

  11 items covering mood, life activities, and medical issues as they relate to sleep and symptoms associated with disorders of sleep. Response options are provided on a 4-point Likert scale with lower scores indicating better outcomes.

  8-months

• Global Sleep Assessment Questionnaire (GSAQ)

  11 items covering mood, life activities, and medical issues as they relate to sleep and symptoms associated with disorders of sleep. Response options are provided on a 4-point Likert scale with lower scores indicating better outcomes.

  12-months

• General and Memory Specific Control Beliefs Scale

  Used to measure perceived control over cognitive health. The scale is composed of two sets of items focusing on general and memory-specific control beliefs. We are interested in examining changes in memory-specific control beliefs, which include 4 items with 3 answer choices.

  4-months

• General and Memory Specific Control Beliefs Scale

  Used to measure perceived control over cognitive health. The scale is composed of two sets of items focusing on general and memory-specific control beliefs. We are interested in examining changes in memory-specific control beliefs, which include 4 items with 3 answer choices.

  8-months

• General and Memory Specific Control Beliefs Scale

  Used to measure perceived control over cognitive health. The scale is composed of two sets of items focusing on general and memory-specific control beliefs. We are interested in examining changes in memory-specific control beliefs, which include 4 items with 3 answer choices.

  12-months

• Philadelphia Geriatric Center Morale Scale (PGCMS)

  17 item scale measuring dimensions of emotional adjustments in persons aged 70 to 90. It provides a multidimensional approach to assessing the state of psychological wellbeing and perceived morale using three factors: agitation, attitude toward own aging and lonely satisfaction. Total score ranges from 0-17 with higher scores indicating higher morality.

  4-months

• Philadelphia Geriatric Center Morale Scale (PGCMS)

  17 item scale measuring dimensions of emotional adjustments in persons aged 70 to 90. It provides a multidimensional approach to assessing the state of psychological wellbeing and perceived morale using three factors: agitation, attitude toward own aging and lonely satisfaction. Total score ranges from 0-17 with higher scores indicating higher morality.

  8-months

• Philadelphia Geriatric Center Morale Scale (PGCMS)

  17 item scale measuring dimensions of emotional adjustments in persons aged 70 to 90. It provides a multidimensional approach to assessing the state of psychological wellbeing and perceived morale using three factors: agitation, attitude toward own aging and lonely satisfaction. Total score ranges from 0-17 with higher scores indicating higher morality.

  12-months

• The NIH Toolbox Meaning and Purpose Short Form

  8-item, form that assesses the degree to which participants feel their lives matter/make sense. Each item is rated on a 5-point Likert scale with responses ranging from "strongly disagree" to "strongly agree" and from "not at all" to "very much." Total score ranges from 8-40 with higher scores indicating better outcomes.

  4-months

• The NIH Toolbox Meaning and Purpose Short Form

  8-item, form that assesses the degree to which participants feel their lives matter/make sense. Each item is rated on a 5-point Likert scale with responses ranging from "strongly disagree" to "strongly agree" and from "not at all" to "very much." Total score ranges from 8-40 with higher scores indicating better outcomes.

  8-months

• The NIH Toolbox Meaning and Purpose Short Form

  8-item, form that assesses the degree to which participants feel their lives matter/make sense. Each item is rated on a 5-point Likert scale with responses ranging from "strongly disagree" to "strongly agree" and from "not at all" to "very much." Total score ranges from 8-40 with higher scores indicating better outcomes.

  12-months

• The Patient Health Questionnaire-9 (PHQ-9)

  Reliable and valid (in a variety of patient populations) multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Response options are provided on a 4-point Likert scale, with total score ranging from 1-27. Lower scores indicate better outcomes.

  4-months

• The Patient Health Questionnaire-9 (PHQ-9)

  Reliable and valid (in a variety of patient populations) multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Response options are provided on a 4-point Likert scale, with total score ranging from 1-27. Lower scores indicate better outcomes.

  8-months

• The Patient Health Questionnaire-9 (PHQ-9)

  Reliable and valid (in a variety of patient populations) multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Response options are provided on a 4-point Likert scale, with total score ranging from 1-27. Lower scores indicate better outcomes.

  12-months

• The Center for Epidemiological Studies-Depression (CES-D)

  20-item measure that rates how often over the past week respondents have experienced depressive symptoms. Response options are provided on a 4-point Likert scale with total scores ranging from 0-60. Lower scores indicate lower depressive symptoms.

  4-months

• The Center for Epidemiological Studies-Depression (CES-D)

  20-item measure that rates how often over the past week respondents have experienced depressive symptoms. Response options are provided on a 4-point Likert scale with total scores ranging from 0-60. Lower scores indicate lower depressive symptoms.

  8-months

• The Center for Epidemiological Studies-Depression (CES-D)

  20-item measure that rates how often over the past week respondents have experienced depressive symptoms. Response options are provided on a 4-point Likert scale with total scores ranging from 0-60. Lower scores indicate lower depressive symptoms.

  12-months

• The State-Trait Anxiety Inventory (STAI)

  Commonly used measure of anxiety with 40 total items. Response options are provided on a 4-point Likert scale. Total score range from 40-160 with lower scores indicating lower anxiety.

  4-months

• The State-Trait Anxiety Inventory (STAI)

  Commonly used measure of anxiety with 40 total items. Response options are provided on a 4-point Likert scale. Total score range from 40-160 with lower scores indicating lower anxiety.

  8-months

• The State-Trait Anxiety Inventory (STAI)

  Commonly used measure of anxiety with 40 total items. Response options are provided on a 4-point Likert scale. Total score range from 40-160 with lower scores indicating lower anxiety.

  12-months

• The General Self-Efficacy Scale (GSE)

  10-item psychometric scale that assesses optimistic self-beliefs to cope with a variety of difficult demands in life. Response options are provided on a 4-point Likert scale with total score ranging from 10-40. Higher total score indicates better outcomes.

  4-months

• The General Self-Efficacy Scale (GSE)

  10-item psychometric scale that assesses optimistic self-beliefs to cope with a variety of difficult demands in life. Response options are provided on a 4-point Likert scale with total score ranging from 10-40. Higher total score indicates better outcomes.

  8-months

• The General Self-Efficacy Scale (GSE)

  10-item psychometric scale that assesses optimistic self-beliefs to cope with a variety of difficult demands in life. Response options are provided on a 4-point Likert scale with total score ranging from 10-40. Higher total score indicates better outcomes.

  12-months

• Multifactorial Memory Questionnaire (MMQ)

  A measure constructed to reflect aspects of memory that are potentially amenable to clinical intervention. The Contentment subscale contains 18 statements that assess emotions and perceptions about current memory ability including anxiety, embarrassment, and irritability. The Ability subscale contains 20 items phrased as memory failures in everyday memory situations (e.g., forgetting an appointment). The Strategy subscale measures self-reported cognitive strategy use. Response options are provided on a 5-point Likert scale. Total score ranges from 0-80 with higher scores indicating better outcomes.

  4-months

• Multifactorial Memory Questionnaire (MMQ)

  A measure constructed to reflect aspects of memory that are potentially amenable to clinical intervention. The Contentment subscale contains 18 statements that assess emotions and perceptions about current memory ability including anxiety, embarrassment, and irritability. The Ability subscale contains 20 items phrased as memory failures in everyday memory situations (e.g., forgetting an appointment). The Strategy subscale measures self-reported cognitive strategy use. Response options are provided on a 5-point Likert scale. Total score ranges from 0-80 with higher scores indicating better outcomes.

  8-months

• Multifactorial Memory Questionnaire (MMQ)

  A measure constructed to reflect aspects of memory that are potentially amenable to clinical intervention. The Contentment subscale contains 18 statements that assess emotions and perceptions about current memory ability including anxiety, embarrassment, and irritability. The Ability subscale contains 20 items phrased as memory failures in everyday memory situations (e.g., forgetting an appointment). The Strategy subscale measures self-reported cognitive strategy use. Response options are provided on a 5-point Likert scale. Total score ranges from 0-80 with higher scores indicating better outcomes.

  12-months

• The Montreal Cognitive Assessment (MoCA)

  Screening instrument that assesses multiple cognitive domains with total score ranging from 0 to 30 points, and a cut score of 24 has demonstrated very good specificity (by correctly identifying 87% of healthy participants) and excellent sensitivity when differentiating MCI (90%) and Alzheimer disease (100%) from healthy comparisons. Total score ranges from 0-30 with higher score indicating better outcomes.

  4-months

• The Montreal Cognitive Assessment (MoCA)

  Screening instrument that assesses multiple cognitive domains with total score ranging from 0 to 30 points, and a cut score of 24 has demonstrated very good specificity (by correctly identifying 87% of healthy participants) and excellent sensitivity when differentiating MCI (90%) and Alzheimer disease (100%) from healthy comparisons. Total score ranges from 0-30 with higher score indicating better outcomes.

  8-months

• The Montreal Cognitive Assessment (MoCA)

  Screening instrument that assesses multiple cognitive domains with total score ranging from 0 to 30 points, and a cut score of 24 has demonstrated very good specificity (by correctly identifying 87% of healthy participants) and excellent sensitivity when differentiating MCI (90%) and Alzheimer disease (100%) from healthy comparisons. Total score ranges from 0-30 with higher score indicating better outcomes.

  12-months

Study Arms (2)

Intervention

EXPERIMENTAL

Receiving intervention - AgeWISE-AP

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

Waitlist Control

NO INTERVENTION

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

Interventions

Aging Well through Interactions and Scientific Education - Action Plan OTHER

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

Also known as: AgeWISE-AP

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Boston Healthcare System: collaborator

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

RECRUITING

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Maureen O'Connor, PsyD

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew H Nguyen, MA

CONTACT

(781) 825-3123; andrew.nguyen@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two arm study: AgeWISE-AP intervention arm and a no treatment waitlist control group arm.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)