Cognitive Decline, Cognitive Deficits, Mild, Cognitive Deterioration, Cognitive Impairment, Mild, Mild Cognitive Impairment
Conditions
Keywords
Memory, Cognitive
Brief summary
The purpose of this study is to develop and test a comprehensive Brain Health Together program for older adults living with cognitive decline.
Detailed description
Older adults with cognitive decline (including either mild cognitive impairment \[MCI\] or subjective cognitive decline \[SCD\]) represent a large market with important unmet needs. Approximately one in three older adults (18 million Americans) are currently living with cognitive decline, which places them at increased risk of developing Alzheimer's disease and related dementias (ADRD). There are no medications that can prevent development of dementia in people with cognitive decline; however, there is growing evidence that behavioral interventions targeting modifiable dementia risk factors-such as increasing physical activity and reducing social isolation-may help improve cognitive function and could potentially delay dementia onset. Preliminary results suggest that Moving TogetherTM program is associated with significant improvements in cognitive function, physical function, social isolation, and self-regulation as well as increased default mode network connectivity on pre/post resting state functional magnetic resonance imaging scans in people with cognitive decline. The investigators believe that these benefits would be even greater if Moving Together were combined with a comprehensive brain health coaching program.
Interventions
BEHAVIORALBrain Health Academy
The Brain Health Academy group will review online content about brain health (1 hour, 2 days/week for 12 weeks) and will complete a brief survey after each module to assess compliance (30 hours total).
BEHAVIORALBrain Health Together
The Brain Health Together group will participate in online, live-streaming, group-based Moving Together classes (1 hour/week); Brain Health education group classes (1 hour/week) and individual brain health coaching sessions (0.5 hours/week) for 12 weeks (30 hours total).
BEHAVIORALMaintain Brain Health Together
The Maintaining Brain Health Together group will participate in the full Brain Health Together program (30 hours) for 12 weeks followed by weekly group classes and six individual coaching for an additional 12 weeks (additional 15 hours).
Sponsors
University of California, San Francisco
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* English language fluency;\* * live in U.S.; * cognitive decline (subjective cognitive decline OR diagnosis of mild cognitive impairment in the past 12 months) * ready to make lifestyle changes to improve brain health; * have 2 or more brain health risk factors (e.g., low physical activity, depression, hypertension, diabetes, etc) * have a desktop or laptop computer or iPad/tablet with a video camera; * have broadband internet access; * able to participate in online, live-streaming classes with two-way video
Exclusion criteria
Candidates meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creyos Cognitive Composite - 3 Month | Baseline to 3 months | The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance. |
| Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 3 Month Change | Baseline to 3 months | This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk. |
| Creyos Cognitive Composite - 6 Month Change | Baseline to 6 months | The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance. |
| Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 6 Month Change | Baseline to 6 months | This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z-score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness / Social Isolation - 3 Month Change | Baseline to 3 months | Loneliness / social isolation was measured using the validated 3-item UCLA Loneliness Scale, which consists of 3 items (lack companionship, feel left out, feel isolated) that are rated as 1 (hardly ever), 2 (some of the time), or 3 (often). Scores may range from 3 to 9, with higher scores reflecting greater loneliness. Raw scores were converted to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased loneliness, negative change scores reflect decreased loneliness. |
| Depression - 3 Month Change | Baseline to 3 months | We assessed depressive symptoms using the validated 10-item version of the Center for Epidemiologic Studies-Depression Scale (CES-D). Participants are asked about feelings in the past week with response categories of 0 (\<1/day), 1 (1-2 days), 2 (3-4 days) or 3 (5-7 days). Scores may range from 0 to 30, with higher scores indicating more depressive symptoms. We concerted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased depressive symptoms; negative change scores reflect reduced depressive symptoms. |
| Cognitive Activity - 3 Month Change | Baseline and 3 months | We measured engagement in cognitive stimulating activities using the validated Cognitive Activity Questionnaire (CAQ). The CAQ includes 11 items that ask how often individuals engage in various cognitive activities such as reading or playing games on a 6-point Likert scale (once a month/never to every day). Higher scores reflect more cognitive activity. We converted raw scores to standardized z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased cognitive activity; negative change scores reflect reduced cognitive activity. |
| Physical Activity - 3 Month Change | Baseline to 3 months | Physical activity was assessed using the using the validated International Physical Activity Questionnaire short form. Participants were asked about time spent (days/week, minutes/day) doing vigorous physical activity, moderate physical activity, walking and sitting in the past 7 days, and responses were converted into metabolic equivalents per week. We converted raw scores into z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased physical activity; negative change scores reflect reduced physical activity. |
| Emotional Well-being - 3 Month Change | Baseline to 3 months | We assessed emotional well-being using the Neuro-QOL v1.0 Positive Affect and Well-Being Short Form, which includes 9 items (e.g. sense of well-being, feeling hopeful, life was satisfying, etc.) with 5-point responses from never (1) to always (5). Scores may range from 9 to 45, with higher scores reflecting greater feelings of well-being. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased well-being; negative change scores reflect decreased emotional well-being. |
| Self-regulation - 3 Month Change | Baseline to 3 months | We measured mind-body awareness using the self-regulation sub-scale of the validated Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2). The self-regulation sub-scale includes 4 items rated on a six-point Likert scale (0/never to 5/always) about the ability to regulate distress by paying attention to bodily sensations (e.g., "When I feel overwhelmed I can find a calm place inside.") Scores reflect the mean of responses (range 0 to 5), with higher scores indicating greater self-regulation. We converted raw score to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved mind-body awareness; negative change scores reflect worse mind-body awareness. |
| Diet - 3 Month Change | Baseline and 3 months | We measured diet using the validated MIND diet score. The MIND diet is a hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets. It has 15 dietary components including 10 brain healthy foods (e.g., green leafy vegetables, berries) and 5 less healthy foods (e.g., red meat, fried/fast foods). The frequency of consumption for each item is scored as 0, 0.5 or 1, and the total MIND diet score is calculated by summing over the 15 components. Scores may range from 0 to 15, with higher scores reflecting better adherence to the MIND diet. We converted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved diet; negative change scores reflect worse diet. |
| Sleep Disturbance - 3 Month Change | Baseline to 3 months | We measured sleep disturbance using the validated PROMIS Sleep Disturbance Short Form 4-item measure, which asks about sleep quality and disturbance in the past 7 days on a 5-point Likert scale. Raw scores are converted to t-scores. Higher scores indicate more sleep disturbance. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased sleep disturbance; negative change scores reflect reduced sleep disturbance. |
| Self-efficacy/Confidence 3 Month Change | Baseline to 3 months | We used a modified version of the Self-Efficacy for Managing Chronic Disease 6-item scale to measure self-efficacy for engaging in activities to support brain health. Each item is rated on an 11-point Likert scale from 0 (not at all confident) to 10 (totally confident). The score is the mean of the 6 items with higher scores reflecting higher self-efficacy. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved self-efficacy; negative change scores reflect worse self-efficacy. |
| Global Quality of Life - Physical - 3 Month Change | Baseline to 3 months | We measured global quality of life using the validated PROMIS Scale v1.2 - Global Health. This scale includes 10 items rated on a 5-point Likert scale from 1 (poor) to 5 (excellent) and includes questions about overall self-rated health, overall quality of life, physical health, mental health, social relationships, fatigue and pain. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life. |
| Global Quality of Life - Mental - 3 Month Change | Baseline to 3 months | We measured global quality of life using the validated PROMIS Scale v1.2 - Global Health. This scale includes 10 items rated on a 5-point Likert scale from 1 (poor) to 5 (excellent) and includes questions about overall self-rated health, overall quality of life, physical health, mental health, social relationships, fatigue and pain. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life. |
| Loneliness / Social Isolation - 6 Month Change | Baseline to 6 months | Loneliness / social isolation was measured using the validated 3-item UCLA Loneliness Scale, which consists of 3 items (lack companionship, feel left out, feel isolated) that are rated as 1 (hardly ever), 2 (some of the time), or 3 (often). Scores may range from 3 to 9, with higher scores reflecting greater loneliness. Raw scores were converted to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased loneliness, negative change scores reflect decreased loneliness. |
| Depression - 6 Month Change | baseline to 6 months | We assessed depressive symptoms using the validated 10-item version of the Center for Epidemiologic Studies-Depression Scale (CES-D). Participants are asked about feelings in the past week with response categories of 0 (\<1/day), 1 (1-2 days), 2 (3-4 days) or 3 (5-7 days). Scores may range from 0 to 30, with higher scores indicating more depressive symptoms. We concerted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased depressive symptoms; negative change scores reflect reduced depressive symptoms. |
| Cognitive Activity - 6 Month Change | Baseline to 6 months | We measured engagement in cognitive stimulating activities using the validated Cognitive Activity Questionnaire (CAQ). The CAQ includes 11 items that ask how often individuals engage in various cognitive activities such as reading or playing games on a 6-point Likert scale (once a month/never to every day). Higher scores reflect more cognitive activity. We converted raw scores to standardized z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased cognitive activity; negative change scores reflect reduced cognitive activity. |
| Physical Activity - 6 Month Change | Baseline to 6 months | Physical activity was assessed using the using the validated International Physical Activity Questionnaire short form. Participants were asked about time spent (days/week, minutes/day) doing vigorous physical activity, moderate physical activity, walking and sitting in the past 7 days, and responses were converted into metabolic equivalents per week. We converted raw scores into z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased physical activity; negative change scores reflect reduced physical activity. |
| Emotional Well-being - 6 Month Change | 0 to 6 months | We assessed emotional well-being using the Neuro-QOL v1.0 Positive Affect and Well-Being Short Form, which includes 9 items (e.g. sense of well-being, feeling hopeful, life was satisfying, etc.) with 5-point responses from never (1) to always (5). Scores may range from 9 to 45, with higher scores reflecting greater feelings of well-being. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased well-being; negative change scores reflect decreased emotional well-being. |
| Self-Regulation - 6 Month Change | 0 to 6 months | We measured mind-body awareness using the self-regulation sub-scale of the validated Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2). The self-regulation sub-scale includes 4 items rated on a six-point Likert scale (0/never to 5/always) about the ability to regulate distress by paying attention to bodily sensations (e.g., "When I feel overwhelmed I can find a calm place inside.") Scores reflect the mean of responses (range 0 to 5), with higher scores indicating greater self-regulation. We converted raw score to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved mind-body awareness; negative change scores reflect worse mind-body awareness. |
| Diet - 6 Month Change | 0 to 6 months | We measured diet using the validated MIND diet score. The MIND diet is a hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets. It has 15 dietary components including 10 brain healthy foods (e.g., green leafy vegetables, berries) and 5 less healthy foods (e.g., red meat, fried/fast foods). The frequency of consumption for each item is scored as 0, 0.5 or 1, and the total MIND diet score is calculated by summing over the 15 components. Scores may range from 0 to 15, with higher scores reflecting better adherence to the MIND diet. We converted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved diet; negative change scores reflect worse diet. |
| Sleep Disturbance - 6 Month Change | 0 to 6 months | We measured sleep disturbance using the validated PROMIS Sleep Disturbance Short Form 4-item measure, which asks about sleep quality and disturbance in the past 7 days on a 5-point Likert scale. Raw scores are converted to t-scores. Higher scores indicate more sleep disturbance. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased sleep disturbance; negative change scores reflect reduced sleep disturbance. |
| Self-efficacy/Confidence - 6 Month Change | 0 to 6 months | We used a modified version of the Self-Efficacy for Managing Chronic Disease 6-item scale to measure self-efficacy for engaging in activities to support brain health. Each item is rated on an 11-point Likert scale from 0 (not at all confident) to 10 (totally confident). The score is the mean of the 6 items with higher scores reflecting higher self-efficacy. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved self-efficacy; negative change scores reflect worse self-efficacy. |
| Global Quality of Life - Physical - 6 Month Change | 0 to 6 months | We measured global quality of life using the validated PROMIS Scale v1.2 - Global Health. This scale includes 10 items rated on a 5-point Likert scale from 1 (poor) to 5 (excellent) and includes questions about overall self-rated health, overall quality of life, physical health, mental health, social relationships, fatigue and pain. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life. |
| Global Quality of Life - Mental - 6 Month Change | 0 to 6 months | We measured global quality of life using the validated PROMIS Scale v1.2 - Global Health. This scale includes 10 items rated on a 5-point Likert scale from 1 (poor) to 5 (excellent) and includes questions about overall self-rated health, overall quality of life, physical health, mental health, social relationships, fatigue and pain. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeborah Barnes, PhD
Primary Investigator
Participant flow
Recruitment details
792 initiated screening process, 342 were ineligible, 242 were not willing to participate or did not complete the screening process, and 208 consented
Pre-assignment details
Of those who consented, 165 (79%) were randomized (55 per group). Reasons for being excluded prior to randomization included time/health conflicts (n=33), change of mind (n=8), unable to reach (n=1), and failing eligibility criteria (n=1).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 7.7 |
| College graduate | 46 Participants |
| Lesbian, gay, or bisexual | 6 Participants |
| Live alone | 53 Participants |
| Married/partnered | 26 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants |
| Race/Ethnicity, Customized Hispanic or Latino/a/e (any race) | 6 Participants |
| Race/Ethnicity, Customized Multiple or Another Race/Ethnicity | 13 Participants |
| Race/Ethnicity, Customized White (not Hispanic/Latino/a/e) | 124 Participants |
| Region of Enrollment United States | 165 participants |
| Sex/Gender, Customized Man | 15 Participants |
| Sex/Gender, Customized Non-binary | 0 Participants |
| Sex/Gender, Customized Not reported | 0 Participants |
| Sex/Gender, Customized Woman | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 20 / 55 | 15 / 55 | 18 / 55 |
| serious Total, serious adverse events | 3 / 55 | 3 / 55 | 2 / 55 |
Outcome results
None listed