xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06006962</url>
    </required_header>
    <id_info>
      <org_study_id>E4828-R</org_study_id>
      <secondary_id>I01RX004828</secondary_id>
      <nct_id>NCT06006962</nct_id>
    </id_info>
    <brief_title>Aging Well Through Interactions and Scientific Education - Action Plan (AgeWISE-AP)</brief_title>
    <acronym>AgeWISE-AP</acronym>
    <official_title>Aging Well Through Interactions and Scientific Education - Action Plan (AgeWISE-AP)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>VA Boston Healthcare System</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>VA Office of Research and Development</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to learn about the effects of AgeWISE-Action Plan (AgeWISE-AP),&#xD;
        a 20-week program designed to provide education and individualized planning with a goal of&#xD;
        improving brain health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The overall goal of this proposal is to conduct a fully powered randomized controlled trial&#xD;
        of a multi-component intervention designed to provide education about brain aging, improve&#xD;
        feelings of control over brain aging, and deliver practical assistance with creation of an&#xD;
        executable action plan (AgeWISE-Action Plan). The AgeWISE-Action Plan (AgeWISE-AP) is&#xD;
        intended to extend our prior AgeWISE program by adding an individualized action plan&#xD;
        component to increase older Veteran engagement in brain healthy lifestyle activities.&#xD;
  &#xD;
        AIM 1 (primary): To determine whether AgeWISE-AP increases older Veterans' engagement in&#xD;
        lifestyle factors that promote brain health. AgeWISE provides information about the&#xD;
        differences between normal and diseased brain aging and lifestyle factors that contribute to&#xD;
        brain health. The action plan (AP) component will use this foundation to collaboratively&#xD;
        create an individualized brain health plan to increase Veteran engagement in brain healthy&#xD;
        lifestyle activities. H1. AgeWISE-AP participants will demonstrate increased engagement in&#xD;
        brain-healthy lifestyle activities compared to the control group.&#xD;
  &#xD;
        AIM 2 (primary): To determine whether AgeWISE-AP improves psychological wellness. AgeWISE&#xD;
        provides information about the relationship between cognitive aging and affective states&#xD;
        (e.g., depression) and attitudes about aging, and teaches stress reduction techniques. The&#xD;
        action plan (AP) will provide additional individualized supports to improve psychological&#xD;
        well-being with personalized goals and lifestyle modifications (e.g., diet, exercise, sleep,&#xD;
        cognitive stimulation). H2. AgeWISE-AP participants will show increases in perception of&#xD;
        control over cognitive aging, meaning and purpose in life, quality of life, and&#xD;
        self-efficacy, as well as improved attitudes toward aging and decreased loneliness,&#xD;
        depression, and anxiety compared to the control group.&#xD;
  &#xD;
        AIM 3 (primary): To determine whether AgeWISE-AP improves cognition. Cognitive strategies to&#xD;
        improve cognition and functioning are presented and practiced over three AgeWISE sessions,&#xD;
        with homework to improve generalization to day-to-day life. Engagement in brain-healthy&#xD;
        lifestyle activities will be accomplished through the action plan (AP). H3. Self-reported&#xD;
        memory contentment, ability, and compensatory strategy use will increase and objective&#xD;
        cognitive testing will be better for AgeWISE-AP participants compared to the control group.&#xD;
  &#xD;
        Aim 4 (exploratory): To determine whether AgeWISE-AP influences biomarkers of brain health&#xD;
        using structural neuroimaging methods. H4. At one-year follow-up AgeWISE-AP participants will&#xD;
        have less volumetric decline in dementia-related brain regions compared to the control group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Two arm study: AgeWISE-AP intervention arm and a no treatment waitlist control group arm.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Health Questionnaire (CHQ)</measure>
      <time_frame>Baseline</time_frame>
      <description>17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health-Promoting Lifestyle Profile II (HPLP II)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS Social Roles and Activities</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Sleep Assessment Questionnaire (GSAQ)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>General and Memory Specific Control Beliefs Scale</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Philadelphia Geriatric Center Morale Scale (PGCMS)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The NIH Toolbox Meaning and Purpose Short Form</measure>
      <time_frame>Baseline</time_frame>
      <description>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 &quot;strongly disagree&quot; to &quot;strongly agree&quot; and from &quot;not at all&quot; to &quot;very much.&quot; Total score ranges from 8-40 with higher scores indicating better outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Patient Health Questionnaire-9 (PHQ-9)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Center for Epidemiological Studies-Depression (CES-D)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The State-Trait Anxiety Inventory (STAI)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The General Self-Efficacy Scale (GSE)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multifactorial Memory Questionnaire (MMQ)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Health Questionnaire (CHQ)</measure>
      <time_frame>4-months</time_frame>
      <description>17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Health Questionnaire (CHQ)</measure>
      <time_frame>8-months</time_frame>
      <description>17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Health Questionnaire (CHQ)</measure>
      <time_frame>12-months</time_frame>
      <description>17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health-Promoting Lifestyle Profile II (HPLP II)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health-Promoting Lifestyle Profile II (HPLP II)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health-Promoting Lifestyle Profile II (HPLP II)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS Social Roles and Activities</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS Social Roles and Activities</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS Social Roles and Activities</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Sleep Assessment Questionnaire (GSAQ)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Sleep Assessment Questionnaire (GSAQ)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Sleep Assessment Questionnaire (GSAQ)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>General and Memory Specific Control Beliefs Scale</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>General and Memory Specific Control Beliefs Scale</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>General and Memory Specific Control Beliefs Scale</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Philadelphia Geriatric Center Morale Scale (PGCMS)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Philadelphia Geriatric Center Morale Scale (PGCMS)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Philadelphia Geriatric Center Morale Scale (PGCMS)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The NIH Toolbox Meaning and Purpose Short Form</measure>
      <time_frame>4-months</time_frame>
      <description>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 &quot;strongly disagree&quot; to &quot;strongly agree&quot; and from &quot;not at all&quot; to &quot;very much.&quot; Total score ranges from 8-40 with higher scores indicating better outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The NIH Toolbox Meaning and Purpose Short Form</measure>
      <time_frame>8-months</time_frame>
      <description>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 &quot;strongly disagree&quot; to &quot;strongly agree&quot; and from &quot;not at all&quot; to &quot;very much.&quot; Total score ranges from 8-40 with higher scores indicating better outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The NIH Toolbox Meaning and Purpose Short Form</measure>
      <time_frame>12-months</time_frame>
      <description>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 &quot;strongly disagree&quot; to &quot;strongly agree&quot; and from &quot;not at all&quot; to &quot;very much.&quot; Total score ranges from 8-40 with higher scores indicating better outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Patient Health Questionnaire-9 (PHQ-9)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Patient Health Questionnaire-9 (PHQ-9)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Patient Health Questionnaire-9 (PHQ-9)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Center for Epidemiological Studies-Depression (CES-D)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Center for Epidemiological Studies-Depression (CES-D)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Center for Epidemiological Studies-Depression (CES-D)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The State-Trait Anxiety Inventory (STAI)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The State-Trait Anxiety Inventory (STAI)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The State-Trait Anxiety Inventory (STAI)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The General Self-Efficacy Scale (GSE)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The General Self-Efficacy Scale (GSE)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The General Self-Efficacy Scale (GSE)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multifactorial Memory Questionnaire (MMQ)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multifactorial Memory Questionnaire (MMQ)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multifactorial Memory Questionnaire (MMQ)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>4-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>8-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>12-months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Cognitive Aging</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Receiving intervention - AgeWISE-AP</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention; will be invited to participate in intervention after completion of study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Aging Well through Interactions and Scientific Education - Action Plan</intervention_name>
      <description>20-week program designed to provide education and individualized planning with a goal of improving brain health.</description>
      <arm_group_label>Intervention</arm_group_label>
      <other_name>AgeWISE-AP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Veterans &gt; 60 years old with concerns about brain aging who want to learn more about&#xD;
               cognitive aging&#xD;
  &#xD;
            -  English speaking as all intervention materials are written in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Veterans with impairment on a cognitive screening measure, as determined using a MoCA&#xD;
               cutoff score for dementia of &lt;24 OR self or other reported diagnosis of a brain&#xD;
               disorder affecting cognition such as Alzheimer's disease, Parkinson's disease, other&#xD;
               dementia, major stroke, or brain injury or diagnosis of psychotic disorder such as&#xD;
               schizophrenia&#xD;
  &#xD;
            -  Active alcohol or substance abuse&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maureen O'Connor, PsyD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Bedford HealthCare System, Bedford, MA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrew H Nguyen, MA</last_name>
      <phone>(781) 825-3123</phone>
      <email>andrew.nguyen@va.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>VA Bedford HealthCare System, Bedford, MA</name>
        <address>
          <city>Bedford</city>
          <state>Massachusetts</state>
          <zip>01730-1114</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Andrew H Nguyen, MA</last_name>
        <phone>781-825-3123</phone>
        <email>andrew.nguyen@va.gov</email>
      </contact>
      <investigator>
        <last_name>Maureen O'Connor, PsyD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cognitive Aging</keyword>
    <keyword>Lifestyle Risk Reduction</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06006962
  org study id: E4828-R
  secondary id: I01RX004828
  nct id: NCT06006962
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two arm study: AgeWISE-AP intervention arm and a no treatment waitlist control group arm.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
  time frame: Baseline
  description: 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.
  measure: Cognitive Health Questionnaire (CHQ)
  time frame: Baseline
  description: 17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.
  measure: Health-Promoting Lifestyle Profile II (HPLP II)
  time frame: Baseline
  description: 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.
  measure: PROMIS Social Roles and Activities
  time frame: Baseline
  description: 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.
  measure: Global Sleep Assessment Questionnaire (GSAQ)
  time frame: Baseline
  description: 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.
  measure: General and Memory Specific Control Beliefs Scale
  time frame: Baseline
  description: 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.
  measure: Philadelphia Geriatric Center Morale Scale (PGCMS)
  time frame: Baseline
  description: 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.
  measure: The NIH Toolbox Meaning and Purpose Short Form
  time frame: Baseline
  description: 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.
  measure: The Patient Health Questionnaire-9 (PHQ-9)
  time frame: Baseline
  description: 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.
  measure: The Center for Epidemiological Studies-Depression (CES-D)
  time frame: Baseline
  description: 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.
  measure: The State-Trait Anxiety Inventory (STAI)
  time frame: Baseline
  description: 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.
  measure: The General Self-Efficacy Scale (GSE)
  time frame: Baseline
  description: 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.
  measure: Multifactorial Memory Questionnaire (MMQ)
  time frame: Baseline
  description: 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.
  measure: The Montreal Cognitive Assessment (MoCA)
  time frame: Baseline
  description: 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.
  measure: Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
  time frame: 4-months
  description: 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.
  measure: Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
  time frame: 8-months
  description: 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.
  measure: Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS)
  time frame: 12-months
  description: 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.
  measure: Cognitive Health Questionnaire (CHQ)
  time frame: 4-months
  description: 17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.
  measure: Cognitive Health Questionnaire (CHQ)
  time frame: 8-months
  description: 17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.
  measure: Cognitive Health Questionnaire (CHQ)
  time frame: 12-months
  description: 17-item scale that assesses frequency of various lifestyle factors, including nutritional variables and use of cognitive strategies in daily life.
  measure: Health-Promoting Lifestyle Profile II (HPLP II)
  time frame: 4-months
  description: 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.
  measure: Health-Promoting Lifestyle Profile II (HPLP II)
  time frame: 8-months
  description: 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.
  measure: Health-Promoting Lifestyle Profile II (HPLP II)
  time frame: 12-months
  description: 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.
  measure: PROMIS Social Roles and Activities
  time frame: 4-months
  description: 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.
  measure: PROMIS Social Roles and Activities
  time frame: 8-months
  description: 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.
  measure: PROMIS Social Roles and Activities
  time frame: 12-months
  description: 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.
  measure: Global Sleep Assessment Questionnaire (GSAQ)
  time frame: 4-months
  description: 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.
  measure: Global Sleep Assessment Questionnaire (GSAQ)
  time frame: 8-months
  description: 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.
  measure: Global Sleep Assessment Questionnaire (GSAQ)
  time frame: 12-months
  description: 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.
  measure: General and Memory Specific Control Beliefs Scale
  time frame: 4-months
  description: 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.
  measure: General and Memory Specific Control Beliefs Scale
  time frame: 8-months
  description: 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.
  measure: General and Memory Specific Control Beliefs Scale
  time frame: 12-months
  description: 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.
  measure: Philadelphia Geriatric Center Morale Scale (PGCMS)
  time frame: 4-months
  description: 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.
  measure: Philadelphia Geriatric Center Morale Scale (PGCMS)
  time frame: 8-months
  description: 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.
  measure: Philadelphia Geriatric Center Morale Scale (PGCMS)
  time frame: 12-months
  description: 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.
  measure: The NIH Toolbox Meaning and Purpose Short Form
  time frame: 4-months
  description: 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.
  measure: The NIH Toolbox Meaning and Purpose Short Form
  time frame: 8-months
  description: 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.
  measure: The NIH Toolbox Meaning and Purpose Short Form
  time frame: 12-months
  description: 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.
  measure: The Patient Health Questionnaire-9 (PHQ-9)
  time frame: 4-months
  description: 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.
  measure: The Patient Health Questionnaire-9 (PHQ-9)
  time frame: 8-months
  description: 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.
  measure: The Patient Health Questionnaire-9 (PHQ-9)
  time frame: 12-months
  description: 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.
  measure: The Center for Epidemiological Studies-Depression (CES-D)
  time frame: 4-months
  description: 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.
  measure: The Center for Epidemiological Studies-Depression (CES-D)
  time frame: 8-months
  description: 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.
  measure: The Center for Epidemiological Studies-Depression (CES-D)
  time frame: 12-months
  description: 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.
  measure: The State-Trait Anxiety Inventory (STAI)
  time frame: 4-months
  description: 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.
  measure: The State-Trait Anxiety Inventory (STAI)
  time frame: 8-months
  description: 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.
  measure: The State-Trait Anxiety Inventory (STAI)
  time frame: 12-months
  description: 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.
  measure: The General Self-Efficacy Scale (GSE)
  time frame: 4-months
  description: 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.
  measure: The General Self-Efficacy Scale (GSE)
  time frame: 8-months
  description: 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.
  measure: The General Self-Efficacy Scale (GSE)
  time frame: 12-months
  description: 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.
  measure: Multifactorial Memory Questionnaire (MMQ)
  time frame: 4-months
  description: 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.
  measure: Multifactorial Memory Questionnaire (MMQ)
  time frame: 8-months
  description: 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.
  measure: Multifactorial Memory Questionnaire (MMQ)
  time frame: 12-months
  description: 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.
  measure: The Montreal Cognitive Assessment (MoCA)
  time frame: 4-months
  description: 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.
  measure: The Montreal Cognitive Assessment (MoCA)
  time frame: 8-months
  description: 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.
  measure: The Montreal Cognitive Assessment (MoCA)
  time frame: 12-months
  description: 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.
  arm group label: Intervention
  arm group type: Experimental
  description: Receiving intervention - AgeWISE-AP
  arm group label: Waitlist Control
  arm group type: No Intervention
  description: No intervention; will be invited to participate in intervention after completion of study.
  intervention type: Other
  intervention name: Aging Well through Interactions and Scientific Education - Action Plan
  description: 20-week program designed to provide education and individualized planning with a goal of improving brain health.
  arm group label: Intervention
  other name: AgeWISE-AP
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maureen O'Connor, PsyD
  role: Principal Investigator
  affiliation: VA Bedford HealthCare System, Bedford, MA
  last name: Andrew H Nguyen, MA
  phone: (781) 825-3123
  email: andrew.nguyen@va.gov
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No