Cognitive AgingAgeWISE-APNCT06006962
Aging Well Through Interactions and Scientific Education - Action Plan (AgeWISE-AP)
A study testing Aging Well through Interactions and Scientific Education - Action Plan in people with Cognitive Aging, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Aging
- What is being tested?
- Aging Well through Interactions and Scientific Education - Action Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
About this study
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.
Read the 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.
- Conditions
- Cognitive Aging
- Being tested
- Aging Well through Interactions and Scientific Education - Action Plan
- Keywords
- Cognitive Aging, Lifestyle Risk Reduction
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aging Well through Interactions and Scientific Education - Action PlanOther
Also called AgeWISE-AP
20-week program designed to provide education and individualized planning with a goal of improving brain health.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receiving intervention - AgeWISE-AP Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Jan 2024
- Primary completion31 May 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm study: AgeWISE-AP intervention arm and a no treatment waitlist control group arm.
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Boston Healthcare System
- Responsible party
- Sponsor
- Investigators
- Maureen O'Connor, PsyD, Principal investigator, VA Bedford HealthCare System, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006962
- Sponsor's protocol ID
- E4828-R
- Other IDs
- I01RX004828
- Acronym
- AgeWISE-AP
- Status last verified
- Jun 2026
- First submitted
- 17 Aug 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Connor MK, Szemko J, McLaren JE, Moo LR, Metcalf EE, Nguyen A, Kraft ML, Frank B, Salat D, Randolph JJ, Tripodis Y. A 20-week, randomized controlled trial to determine the efficacy of the Aging Well through Interaction and Scientific Education - Action Plan (AgeWISE-AP) program in older Veterans. BMC Geriatr. 2025 Aug 4;25(1):588. doi: 10.1186/s12877-025-06207-x.
PubMed 40760411
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging Well Through Interactions and Scientific Education - Action Plan (AgeWISE-AP)
- ClinicalTrials.gov ID
- NCT06006962
- Acronym / sponsor ID
- AgeWISE-AP / E4828-R
- Conditions
- Cognitive Aging
- Keywords
- Cognitive Aging, Lifestyle Risk Reduction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 134 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Boston Healthcare System
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm study: AgeWISE-AP intervention arm and a no treatment waitlist control group arm.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Aging Well through Interactions and Scientific Education - Action PlanReceiving intervention - AgeWISE-AP |
| Waitlist Control | No intervention | –No intervention; will be invited to participate in intervention after completion of study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aging Well through Interactions and Scientific Education - Action PlanAlso: AgeWISE-AP20-week program designed to provide education and individualized planning with a goal of improving brain health. | Other | Intervention |
Primary outcome
Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
Time frame: Baseline
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.
Cognitive Health Questionnaire (CHQ)
Time frame: Baseline
17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.
Health-Promoting Lifestyle Profile II (HPLP II)
Time frame: Baseline
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.
PROMIS Social Roles and Activities
Time frame: Baseline
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.
Global Sleep Assessment Questionnaire (GSAQ)
Time frame: Baseline
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.
General and Memory Specific Control Beliefs Scale
Time frame: Baseline
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.
Philadelphia Geriatric Center Morale Scale (PGCMS)
Time frame: Baseline
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.
The NIH Toolbox Meaning and Purpose Short Form
Time frame: Baseline
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.
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
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.
The Center for Epidemiological Studies-Depression (CES-D)
Time frame: Baseline
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.
The State-Trait Anxiety Inventory (STAI)
Time frame: Baseline
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.
The General Self-Efficacy Scale (GSE)
Time frame: Baseline
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.
Multifactorial Memory Questionnaire (MMQ)
Time frame: Baseline
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.
The Montreal Cognitive Assessment (MoCA)
Time frame: Baseline
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.
Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
Time frame: 4-months
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.
Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
Time frame: 8-months
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.
Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
Time frame: 12-months
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.
Cognitive Health Questionnaire (CHQ)
Time frame: 4-months
17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.
Cognitive Health Questionnaire (CHQ)
Time frame: 8-months
17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.
Cognitive Health Questionnaire (CHQ)
Time frame: 12-months
17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.
Health-Promoting Lifestyle Profile II (HPLP II)
Time frame: 4-months
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.
Health-Promoting Lifestyle Profile II (HPLP II)
Time frame: 8-months
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.
Health-Promoting Lifestyle Profile II (HPLP II)
Time frame: 12-months
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.
PROMIS Social Roles and Activities
Time frame: 4-months
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.
PROMIS Social Roles and Activities
Time frame: 8-months
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.
PROMIS Social Roles and Activities
Time frame: 12-months
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.
Global Sleep Assessment Questionnaire (GSAQ)
Time frame: 4-months
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.
Global Sleep Assessment Questionnaire (GSAQ)
Time frame: 8-months
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.
Global Sleep Assessment Questionnaire (GSAQ)
Time frame: 12-months
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.
General and Memory Specific Control Beliefs Scale
Time frame: 4-months
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.
General and Memory Specific Control Beliefs Scale
Time frame: 8-months
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.
General and Memory Specific Control Beliefs Scale
Time frame: 12-months
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.
Philadelphia Geriatric Center Morale Scale (PGCMS)
Time frame: 4-months
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.
Philadelphia Geriatric Center Morale Scale (PGCMS)
Time frame: 8-months
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.
Philadelphia Geriatric Center Morale Scale (PGCMS)
Time frame: 12-months
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.
The NIH Toolbox Meaning and Purpose Short Form
Time frame: 4-months
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.
The NIH Toolbox Meaning and Purpose Short Form
Time frame: 8-months
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.
The NIH Toolbox Meaning and Purpose Short Form
Time frame: 12-months
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.
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: 4-months
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.
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: 8-months
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.
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12-months
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.
The Center for Epidemiological Studies-Depression (CES-D)
Time frame: 4-months
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.
The Center for Epidemiological Studies-Depression (CES-D)
Time frame: 8-months
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.
The Center for Epidemiological Studies-Depression (CES-D)
Time frame: 12-months
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.
The State-Trait Anxiety Inventory (STAI)
Time frame: 4-months
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.
The State-Trait Anxiety Inventory (STAI)
Time frame: 8-months
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.
The State-Trait Anxiety Inventory (STAI)
Time frame: 12-months
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.
The General Self-Efficacy Scale (GSE)
Time frame: 4-months
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.
The General Self-Efficacy Scale (GSE)
Time frame: 8-months
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.
The General Self-Efficacy Scale (GSE)
Time frame: 12-months
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.
Multifactorial Memory Questionnaire (MMQ)
Time frame: 4-months
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.
Multifactorial Memory Questionnaire (MMQ)
Time frame: 8-months
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.
Multifactorial Memory Questionnaire (MMQ)
Time frame: 12-months
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.
The Montreal Cognitive Assessment (MoCA)
Time frame: 4-months
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.
The Montreal Cognitive Assessment (MoCA)
Time frame: 8-months
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.
The Montreal Cognitive Assessment (MoCA)
Time frame: 12-months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 40760411O'Connor MK, Szemko J, McLaren JE, Moo LR, Metcalf EE, Nguyen A, Kraft ML, Frank B, Salat D, Randolph JJ, Tripodis Y. A 20-week, randomized controlled trial to determine the efficacy of the Aging Well through Interaction and Scientific Education - Action Plan (AgeWISE-AP) program in older Veterans. BMC Geriatr. 2025 Aug 4;25(1):588. doi: 10.1186/s12877-025-06207-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen O'Connor, PsyD principal investigator
VA Bedford HealthCare System, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aging Well through Interactions and Scientific Education - Action Plan in people with Cognitive Aging, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS) (time frame: Baseline). The study lists 56 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.