Alzheimer Disease, Dementia
Conditions
Brief summary
To determine whether Moving Together improves quality of life in people with memory loss (PWML) and caregivers (CG) by performing a randomized, controlled trial (RCT) with a waitlist control group in 224 dyads.
Detailed description
The investigators will perform an RCT with a 12-week delayed start control group in 224 dyads of PWMLs and CGs. The primary outcome in PWML will be self-rated quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Secondary outcomes will include: a) self-reported emotional well-being; b) self-reported social isolation; c) self-reported mobility; and d) directly assess cognitive performance. In CGs, the primary outcome will be self-rated quality of life (SF-12). Secondary outcomes in CGs will include: a) healthy days; b) self-efficacy; c) burden; d) social isolation; e) ability to self-regulate; f) positive affect; and g) sleep quality. In addition, the investigators will ask CGs to report sleep quality, mobility, and cognitive function for PWML. Additional exploratory outcomes will include health services utilization (hospitalizations, emergency department visits) and falls. In addition to the RCT, the investigators propose to compare health utilization outcomes in study participants to a matched 'no contact' comparison sample of patients with dementia diagnoses who receive care in the University of California San Francisco (UCSF) Health system.
Interventions
BEHAVIORALMoving Together
Two-way livestreaming virtual group classes will be offered for 1 hour, 2 days/week for 12 weeks to all participants. Classes will be led by a trained instructor who will demonstrate all movements and will provide brief explanations for the goals of movements. Consistent with the in-person program, classes will focus on the 7 guiding principles of Moving Together: 1. repetition with variation (to promote procedural learning); 2. progressive, functional movements (to improve daily function); 3. slow pace and step-by-step instruction (to minimize cognitive demands); 4. participant-centered goal orientation (to enhance personal meaningfulness of movements); 5. body awareness, mindfulness and breathing (to encourage present-centeredness); 6. social interaction (to promote meaningful connection); and 7. positive emotions (to promote feelings of well-being.
Sponsors
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Dyads will be enrolled and randomized in blocks of 16 (n=8 immediate start, n=8 waitlist). The randomization sequence will be generated in advance by Dr. Barnes' team using a random number generator and will be maintained in a secure location. Individuals who collect or analyze outcome data will be unaware of the randomization sequence and blinded to group assignment.
Intervention model description
Delayed-start control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* People with memory loss (PWML): * U.S. resident; * English language fluency; * diagnosis of Alzheimer's disease or other dementia; mild severity, assessed using the Quick Dementia Rating System. * Caregivers (CG): * U.S. resident; * English language fluency; * Primary caregiver for PWML; * own one or more devices that can be used to participate in two-way livestreaming video classes (e.g., smart phone/tablet + TV, laptop or desktop with webcam, smart TV); * willing and able to participate in two-way livestreaming group movement classes with person with PWML.
Exclusion criteria
* Age \< 18 years; * primarily use wheelchair inside home; * limited life expectancy (e.g., enrolled in hospice, meta-static cancer); * physical limitations that could affect ability to participate (e.g., difficulty sitting for 1 hour, chronic pain, vertigo); * severe visual impairment (e.g., unable to observe instructor's movements on screen); * severe hearing impairment (e.g., unable to hear instructor's requests); * behavioral or psychiatric issues that could be disruptive in group setting (e.g., history of physical or verbal abuse, schizophrenia, bipolar disorder, substance abuse); * unable to provide consent/assent; * planning to travel for \>1 week during initial 12-week study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS]) | Baseline to 12 weeks | The Short Form Health Survey (SF-12) is a 12-item questionnaire that was developed as a shorter alternative to the SF-36 Health Survey (SF-36). It consists of a subset of 12 items from the SF-36 covering the same eight domains of health outcomes and generates two summary scores: the Physical and Mental Health Composite Scores (PCS, MCS). Scores may range from 0-100, with higher scores reflecting better levels of health. |
| Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS]) | Baseline to 12-weeks | The Short Form Health Survey (SF-12) is a 12-item questionnaire that was developed as a shorter alternative to the SF-36 Health Survey (SF-36). It consists of a subset of 12 items from the SF-36 covering the same eight domains of health outcomes and generates two summary scores: the Physical and Mental Health Composite Scores (PCS, MCS). Scores may range from 0-100, with higher scores reflecting better levels of health. |
| Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD) | Baseline to 12-weeks | The QOL-AD is a standard quality of life measure that has been validated for people with cognitive impairment. Scores may range from 0-52, with higher scores reflecting better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility) | Baseline to 12-weeks | The (Neuro-QOL Short Form v1.0 -- Lower Extremity Function -- Mobility), which includes 8 items for functional mobility (getting on and off the toilet, getting in and out of a car, getting out of bed into a chair). Responses are rated on a 5-point Likert scale: 1( Without any difficult), 2 (With a little difficulty), 3 (With some difficulty), 4 (With much difficulty), 5 (Unable to do). Scores may range from 0-40 with higher scores indicating increased mobility. |
| Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA) | Baseline to 12-weeks | The t-MoCA is extracted from the original face-to-face MoCA and uses items not requiring the use of a pencil and paper or visual stimulus. Scores may range from 0-22 with higher scores indicating higher cognitive function. |
| Caregiver Healthy Days - Change (Healthy Days Core Module) | Baseline to 12-weeks | The Healthy Days Core Modules includes 3 questions about the number of days during the past 30 days that physical or mental health was not good or poor physical or mental health kept from doing usual activities. Scores range from 0-18 with lower scores indicating higher physical or mental health. |
| Caregiver Self-efficacy - Change (Gain in Alzheimer Care INstrument (GAIN)) | Baseline to 12-weeks | The GAIN consists of 10-items (e.g., increased my self-awareness, increased my knowledge and skills in dementia care) using a Likert scale from 0 (disagree a lot) to 4 (agree a lot). Scores range from 0 to 40 with higher scores indicating increased positive feelings about caregiving |
| Caregiver Burden - Change (Zarit Burden Interview, 6-item Version) | Baseline to 12-weeks | The Zarit Burden Interview is one of the most widely used assessments for caregiver burden covering areas including caregiver's health, psychological well-being, finances, social life, and the relationship between the caregiver and the person with dementia. Scores range from 0-24 with higher scores indicating positive caregiver experience. |
| Caregiver Self-regulation - Change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) Self-regulation Subscale) | Change from baseline to 12-weeks | The MAIA-2 - Self-regulation subscale is designed to assess ability to regulate distress by attention to body sensations (e.g., when I feel overwhelmed, I can find a calm place inside). Scores range from 0-20 with higher scores indicating increased self-regulation. |
| Caregiver Positive Affect (Positive States of Mind) | Baseline to 12-weeks | The Positive States of Mind scale is designed to assess types of positive mood (e.g., focused attention, productivity, responsible caregiving, etc.). This scale consists of 6-items using a 4-point Likert scale from 0 (Unable to have it) to 3 (Have it Easily). Scores range from 0-18 with higher scores indicating positive mood. |
| Caregiver Sleep - Change (Symptom Checklist, 3 Items) | Baseline to 12-weeks | The Symptom Checklist-90-Revised is a 90-item self-report questionnaire often used to assess global psychological distress and the investigators will be using 3 items assessing: trouble falling asleep, awakening in the early morning, and sleep that is restless or disturbed. Scores range from 0-12 with lower scores indicating less sleep difficulties. |
| People With Memory Loss (PWML) Sleep - Change (Symptom Checklist, 3 Items) | Baseline to 12-weeks | Caregivers also will be asked about sleep for the PWML using the 3 sleep items from the Symptom Checklist-90-Revised (trouble falling asleep, awakening in the early morning, and sleep that is restless or disturbed). Scores range from 0-12 with lower scores indicating less sleep difficulties. |
| People With Memory Loss (PWML) Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility) | Baseline to 12-weeks | As described above, the Neuro-QOL Short Form v1.0 - Lower Extremity Function - Mobility includes 8 items for functional mobility (e.g. getting on and off the toilet, getting in and out of a car, getting out of bed into a chair, etc.). CGs will be asked about the mobility of the PWML. Scores range from 0-35 with higher scores indicating less physical difficulty with daily activities. |
| People With Memory Loss (PWML) Cognitive Function - Change (Cognitive Function Instrument - Modified) | Baseline to 12-weeks | The original Cognitive Function Instrument included 14 items that asked about decline in cognitive function (e.g., memory, tendency to repeat questions, misplacing things, etc.) compared to 1 year ago with responses of yes (1), no (0) or maybe (0.5). The investigators will be using a modified 11-item version that excludes items on driving, managing money, work; asking about change in the past 3 months (to match the duration of our study); and using a 5-point Likert scale from 1 (a lot worse) to 5 (a lot better). Scores range from 0-55 with higher scores indicating improved cognitive function. |
| Caregiver Social Isolation - Change (PROMIS v2.0 Social Isolation Scale) | Baseline to 12-weeks | The Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale consists of 4 items (feeling left out, people barely know me, feeling isolated, people are around but not with me) that are rated as 1 (never), 2 (rarely), 3 (sometimes), 4 (usually), or 5 (always). Scores range from 0-20 with higher scores indicating less perceived social isolation. |
| Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form) | Baseline to 12-weeks | The Neuro-QOL v1.0 Positive Affect and Well-Being Short Form 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 range from 0-40 with higher scores indicating increased mobility. |
| Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale) | Baseline to 12-weeks | The Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale consists of 4 items (feeling left out, people barely know me, feeling isolated, people are around but not with me) that are rated as 1 (never), 2 (rarely), 3 (sometimes), 4 (usually), or 5 (always). Scores range from 0-20 with higher scores indicating less perceived social isolation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Caregiver (CG) Falls | Baseline to 12 weeks | Total number of falls reported for CG for the entire group (not per CG) |
| People With Memory Loss (PWML) Falls | Baseline to 12 weeks | Total number of falls reported for PWML in the entire group (not per participant). |
Countries
United States
Participant flow
Recruitment details
Study participants are enrolled as dyads of persons living with dementia (PLWD) and care partners (CPs).
Participants by arm
| Arm | Count |
|---|---|
| Waitlist Control Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks. | 86 |
| Moving Together Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks. | 108 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 12 to 24 Weeks | Lost to Follow-up | 1 | 0 | 1 | 0 |
| 12 to 24 Weeks | Withdrawal by Subject | 3 | 2 | 3 | 2 |
| Baseline to 12 Weeks | Lost to Follow-up | 0 | 1 | 0 | 1 |
| Baseline to 12 Weeks | Withdrawal by Subject | 6 | 8 | 6 | 8 |
Baseline characteristics
| Characteristic | Waitlist Control | Total | Moving Together |
|---|---|---|---|
| Age, Continuous Care partners | 68.9 years STANDARD_DEVIATION 11 | 65.8 years STANDARD_DEVIATION 11.7 | 63.3 years STANDARD_DEVIATION 11.8 |
| Age, Continuous Participants with dementia | 76.8 years STANDARD_DEVIATION 9.7 | 76.4 years STANDARD_DEVIATION 10.6 | 76.2 years STANDARD_DEVIATION 11.3 |
| Dementia Diagnosis Alzheimer's disease | 12 Participants | 29 Participants | 17 Participants |
| Dementia Diagnosis Dementia unspecified | 4 Participants | 19 Participants | 15 Participants |
| Dementia Diagnosis Mild cognitive impairment | 7 Participants | 13 Participants | 6 Participants |
| Dementia Diagnosis Mixed dementia | 4 Participants | 5 Participants | 1 Participants |
| Dementia Diagnosis Other/unknown type of dementia | 11 Participants | 21 Participants | 10 Participants |
| Dementia Diagnosis Vascular dementia | 5 Participants | 10 Participants | 5 Participants |
| Education Care partners | 17.0 years STANDARD_DEVIATION 3.2 | 16.8 years STANDARD_DEVIATION 3 | 16.7 years STANDARD_DEVIATION 2.8 |
| Education Participants with dementia | 16.2 years STANDARD_DEVIATION 3.1 | 16.5 years STANDARD_DEVIATION 3 | 16.8 years STANDARD_DEVIATION 2.8 |
| Quick Dementia Rating System (QDRS) | 7.5 points on a scale STANDARD_DEVIATION 2.9 | 7.7 points on a scale STANDARD_DEVIATION 3 | 7.8 points on a scale STANDARD_DEVIATION 2.3 |
| Race/Ethnicity, Customized Care partners Asian | 5 Participants | 14 Participants | 9 Participants |
| Race/Ethnicity, Customized Care partners Black or African American | 0 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized Care partners Hispanic/Latino/a/x (any race) | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Care partners Non-Hispanic White | 33 Participants | 69 Participants | 36 Participants |
| Race/Ethnicity, Customized Care partners Other/unknown race/ethnicity | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Participants with dementia Asian | 3 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Participants with dementia Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Participants with dementia Hispanic/Latino/a/x (any race) | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Participants with dementia Non-Hispanic White | 36 Participants | 78 Participants | 42 Participants |
| Race/Ethnicity, Customized Participants with dementia Other/unknown race/ethnicity | 1 Participants | 3 Participants | 2 Participants |
| Relationship to PLWD Child or child-in-law | 9 Participants | 24 Participants | 15 Participants |
| Relationship to PLWD Other relationship | 2 Participants | 4 Participants | 2 Participants |
| Relationship to PLWD Paid | 1 Participants | 4 Participants | 3 Participants |
| Relationship to PLWD Spouse or partner | 31 Participants | 65 Participants | 34 Participants |
| Sex: Female, Male Care partners Female | 32 Participants | 76 Participants | 44 Participants |
| Sex: Female, Male Care partners Male | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Participants with dementia Female | 21 Participants | 42 Participants | 21 Participants |
| Sex: Female, Male Participants with dementia Male | 22 Participants | 55 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 54 | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 3 / 54 | 17 / 54 | 8 / 43 | 15 / 43 |
| serious Total, serious adverse events | 1 / 54 | 7 / 54 | 1 / 43 | 3 / 43 |
Outcome results
Primary
Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS])
The Short Form Health Survey (SF-12) is a 12-item questionnaire that was developed as a shorter alternative to the SF-36 Health Survey (SF-36). It consists of a subset of 12 items from the SF-36 covering the same eight domains of health outcomes and generates two summary scores: the Physical and Mental Health Composite Scores (PCS, MCS). Scores may range from 0-100, with higher scores reflecting better levels of health.
Time frame: Baseline to 12 weeks
Population: Only measured in CPs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS]) | -0.7 score on a scale | Standard Deviation 7.9 |
| Moving Together - PLWD | Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS]) | 0.0 score on a scale | Standard Deviation 8.1 |
p-value: 0.73495% CI: [-2.75, 3.92]Mixed Models Analysis
Primary
Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS])
The Short Form Health Survey (SF-12) is a 12-item questionnaire that was developed as a shorter alternative to the SF-36 Health Survey (SF-36). It consists of a subset of 12 items from the SF-36 covering the same eight domains of health outcomes and generates two summary scores: the Physical and Mental Health Composite Scores (PCS, MCS). Scores may range from 0-100, with higher scores reflecting better levels of health.
Time frame: Baseline to 12-weeks
Population: Measured only in CPs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS]) | 0.2 score on a scale | Standard Deviation 8 |
| Moving Together - PLWD | Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS]) | -0.6 score on a scale | Standard Deviation 7.7 |
p-value: 0.60395% CI: [-4.12, 2.4]Mixed Models Analysis
Primary
Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
The QOL-AD is a standard quality of life measure that has been validated for people with cognitive impairment. Scores may range from 0-52, with higher scores reflecting better quality of life.
Time frame: Baseline to 12-weeks
Population: Only measured in PLWD. Baseline data missing for 1 participant in the Moving Together group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD) | -1.7 score on a scale | Standard Deviation 0.6 |
| Moving Together - PLWD | Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD) | 0.7 score on a scale | Standard Deviation 4.2 |
p-value: 0.04895% CI: [0.01, 4.39]Mixed Models Analysis
Secondary
Caregiver Burden - Change (Zarit Burden Interview, 6-item Version)
The Zarit Burden Interview is one of the most widely used assessments for caregiver burden covering areas including caregiver's health, psychological well-being, finances, social life, and the relationship between the caregiver and the person with dementia. Scores range from 0-24 with higher scores indicating positive caregiver experience.
Time frame: Baseline to 12-weeks
Population: Measure applies to CPs only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Caregiver Burden - Change (Zarit Burden Interview, 6-item Version) | -0.2 score on a scale | Standard Deviation 3.1 |
| Moving Together - PLWD | Caregiver Burden - Change (Zarit Burden Interview, 6-item Version) | 0.4 score on a scale | Standard Deviation 3.5 |
p-value: 0.38495% CI: [-0.77, 2]Mixed Models Analysis
Secondary
Caregiver Healthy Days - Change (Healthy Days Core Module)
The Healthy Days Core Modules includes 3 questions about the number of days during the past 30 days that physical or mental health was not good or poor physical or mental health kept from doing usual activities. Scores range from 0-18 with lower scores indicating higher physical or mental health.
Time frame: Baseline to 12-weeks
Population: Measure applies to CPs only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Caregiver Healthy Days - Change (Healthy Days Core Module) | 0.0 score on a scale | Standard Deviation 2.5 |
| Moving Together - PLWD | Caregiver Healthy Days - Change (Healthy Days Core Module) | 0.5 score on a scale | Standard Deviation 2.8 |
p-value: 0.48495% CI: [-0.71, 1.49]Mixed Models Analysis
Secondary
Caregiver Positive Affect (Positive States of Mind)
The Positive States of Mind scale is designed to assess types of positive mood (e.g., focused attention, productivity, responsible caregiving, etc.). This scale consists of 6-items using a 4-point Likert scale from 0 (Unable to have it) to 3 (Have it Easily). Scores range from 0-18 with higher scores indicating positive mood.
Time frame: Baseline to 12-weeks
Population: Measure applies to CPs only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Caregiver Positive Affect (Positive States of Mind) | 0.5 score on a scale | Standard Deviation 2.1 |
| Moving Together - PLWD | Caregiver Positive Affect (Positive States of Mind) | -0.3 score on a scale | Standard Deviation 3.1 |
p-value: 0.15695% CI: [-1.94, 0.31]Mixed Models Analysis
Secondary
Caregiver Self-efficacy - Change (Gain in Alzheimer Care INstrument (GAIN))
The GAIN consists of 10-items (e.g., increased my self-awareness, increased my knowledge and skills in dementia care) using a Likert scale from 0 (disagree a lot) to 4 (agree a lot). Scores range from 0 to 40 with higher scores indicating increased positive feelings about caregiving
Time frame: Baseline to 12-weeks
Population: Measure applies to CPs only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Caregiver Self-efficacy - Change (Gain in Alzheimer Care INstrument (GAIN)) | 0.1 score on a scale | Standard Deviation 5 |
| Moving Together - PLWD | Caregiver Self-efficacy - Change (Gain in Alzheimer Care INstrument (GAIN)) | 0.5 score on a scale | Standard Deviation 7.4 |
p-value: 0.8195% CI: [-2.36, 3.01]Mixed Models Analysis
Secondary
Caregiver Self-regulation - Change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) Self-regulation Subscale)
The MAIA-2 - Self-regulation subscale is designed to assess ability to regulate distress by attention to body sensations (e.g., when I feel overwhelmed, I can find a calm place inside). Scores range from 0-20 with higher scores indicating increased self-regulation.
Time frame: Change from baseline to 12-weeks
Population: Measure applies to CPs only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Caregiver Self-regulation - Change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) Self-regulation Subscale) | 0.3 score on a scale | Standard Deviation 2.4 |
| Moving Together - PLWD | Caregiver Self-regulation - Change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) Self-regulation Subscale) | 1.9 score on a scale | Standard Deviation 3.9 |
p-value: 0.02195% CI: [0.24, 3.01]Mixed Models Analysis
Secondary
Caregiver Sleep - Change (Symptom Checklist, 3 Items)
The Symptom Checklist-90-Revised is a 90-item self-report questionnaire often used to assess global psychological distress and the investigators will be using 3 items assessing: trouble falling asleep, awakening in the early morning, and sleep that is restless or disturbed. Scores range from 0-12 with lower scores indicating less sleep difficulties.
Time frame: Baseline to 12-weeks
Population: Measure only applies to CPs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Caregiver Sleep - Change (Symptom Checklist, 3 Items) | -0.1 score on a scale | Standard Deviation 1.9 |
| Moving Together - PLWD | Caregiver Sleep - Change (Symptom Checklist, 3 Items) | 0.2 score on a scale | Standard Deviation 2.1 |
p-value: 0.58295% CI: [-0.62, 1.1]Mixed Models Analysis
Secondary
Caregiver Social Isolation - Change (PROMIS v2.0 Social Isolation Scale)
The Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale consists of 4 items (feeling left out, people barely know me, feeling isolated, people are around but not with me) that are rated as 1 (never), 2 (rarely), 3 (sometimes), 4 (usually), or 5 (always). Scores range from 0-20 with higher scores indicating less perceived social isolation.
Time frame: Baseline to 12-weeks
Population: Measure applies to CPs only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Caregiver Social Isolation - Change (PROMIS v2.0 Social Isolation Scale) | 0.3 score on a scale | Standard Deviation 2.3 |
| Moving Together - PLWD | Caregiver Social Isolation - Change (PROMIS v2.0 Social Isolation Scale) | -0.1 score on a scale | Standard Deviation 3.4 |
p-value: 0.50995% CI: [-1.65, 0.81]Mixed Models Analysis
Secondary
Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA)
The t-MoCA is extracted from the original face-to-face MoCA and uses items not requiring the use of a pencil and paper or visual stimulus. Scores may range from 0-22 with higher scores indicating higher cognitive function.
Time frame: Baseline to 12-weeks
Population: Measured only in PLWD. Data missing for 1 Moving Together participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA) | -0.8 score on a scale | Standard Deviation 3.3 |
| Moving Together - PLWD | Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA) | -0.5 score on a scale | Standard Deviation 2.5 |
p-value: 0.63195% CI: [-0.96, 1.58]Mixed Models Analysis
Secondary
Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
The (Neuro-QOL Short Form v1.0 -- Lower Extremity Function -- Mobility), which includes 8 items for functional mobility (getting on and off the toilet, getting in and out of a car, getting out of bed into a chair). Responses are rated on a 5-point Likert scale: 1( Without any difficult), 2 (With a little difficulty), 3 (With some difficulty), 4 (With much difficulty), 5 (Unable to do). Scores may range from 0-40 with higher scores indicating increased mobility.
Time frame: Baseline to 12-weeks
Population: Measure applies to PLWD. Data missing for 1 Moving Together participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility) | -1.6 score on a scale | Standard Deviation 5 |
| Moving Together - PLWD | Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility) | 0.3 score on a scale | Standard Deviation 3.7 |
p-value: 0.08995% CI: [-0.26, 3.51]Mixed Models Analysis
Secondary
People With Memory Loss (PWML) Cognitive Function - Change (Cognitive Function Instrument - Modified)
The original Cognitive Function Instrument included 14 items that asked about decline in cognitive function (e.g., memory, tendency to repeat questions, misplacing things, etc.) compared to 1 year ago with responses of yes (1), no (0) or maybe (0.5). The investigators will be using a modified 11-item version that excludes items on driving, managing money, work; asking about change in the past 3 months (to match the duration of our study); and using a 5-point Likert scale from 1 (a lot worse) to 5 (a lot better). Scores range from 0-55 with higher scores indicating improved cognitive function.
Time frame: Baseline to 12-weeks
Population: Measure asked CPs about PLWD.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | People With Memory Loss (PWML) Cognitive Function - Change (Cognitive Function Instrument - Modified) | 1.5 score on a scale | Standard Deviation 5.1 |
| Moving Together - PLWD | People With Memory Loss (PWML) Cognitive Function - Change (Cognitive Function Instrument - Modified) | 1.8 score on a scale | Standard Deviation 6.1 |
p-value: 0.52995% CI: [-1.62, 3.15]Mixed Models Analysis
Secondary
People With Memory Loss (PWML) Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
As described above, the Neuro-QOL Short Form v1.0 - Lower Extremity Function - Mobility includes 8 items for functional mobility (e.g. getting on and off the toilet, getting in and out of a car, getting out of bed into a chair, etc.). CGs will be asked about the mobility of the PWML. Scores range from 0-35 with higher scores indicating less physical difficulty with daily activities.
Time frame: Baseline to 12-weeks
Population: Measure asked of CPs regarding PLWD.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | People With Memory Loss (PWML) Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility) | -0.3 score on a scale | Standard Deviation 4.9 |
| Moving Together - PLWD | People With Memory Loss (PWML) Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility) | -0.2 score on a scale | Standard Deviation 3.1 |
p-value: 0.83495% CI: [-1.52, 1.88]Mixed Models Analysis
Secondary
People With Memory Loss (PWML) Sleep - Change (Symptom Checklist, 3 Items)
Caregivers also will be asked about sleep for the PWML using the 3 sleep items from the Symptom Checklist-90-Revised (trouble falling asleep, awakening in the early morning, and sleep that is restless or disturbed). Scores range from 0-12 with lower scores indicating less sleep difficulties.
Time frame: Baseline to 12-weeks
Population: Measure only asked of CPs regarding PLWD.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | People With Memory Loss (PWML) Sleep - Change (Symptom Checklist, 3 Items) | 0.1 score on a scale | Standard Deviation 2 |
| Moving Together - PLWD | People With Memory Loss (PWML) Sleep - Change (Symptom Checklist, 3 Items) | -0.3 score on a scale | Standard Deviation 1.7 |
p-value: 0.27195% CI: [-1.21, 0.34]Mixed Models Analysis
Secondary
Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale)
The Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale consists of 4 items (feeling left out, people barely know me, feeling isolated, people are around but not with me) that are rated as 1 (never), 2 (rarely), 3 (sometimes), 4 (usually), or 5 (always). Scores range from 0-20 with higher scores indicating less perceived social isolation.
Time frame: Baseline to 12-weeks
Population: Measured in PLWD. Data missing for 1 participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale) | -0.2 score on a scale | Standard Deviation 3.6 |
| Moving Together - PLWD | Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale) | -0.5 score on a scale | Standard Deviation 4.4 |
p-value: 0.81895% CI: [-1.97, 1.56]Mixed Models Analysis
Secondary
Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)
The Neuro-QOL v1.0 Positive Affect and Well-Being Short Form 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 range from 0-40 with higher scores indicating increased mobility.
Time frame: Baseline to 12-weeks
Population: Only measured in PLWD. Data missing for 1 participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist Control - PLWD | Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form) | -1.7 score on a scale | Standard Deviation 6.1 |
| Moving Together - PLWD | Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form) | 0.1 score on a scale | Standard Deviation 4 |
p-value: 0.15995% CI: [-0.62, 3.74]Mixed Models Analysis
Other Pre-specified
Caregiver (CG) Falls
Total number of falls reported for CG for the entire group (not per CG)
Time frame: Baseline to 12 weeks
Population: Applies to CPs only. Data missing for 2 Waitlist and 6 Moving Together CPs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Waitlist Control - PLWD | Caregiver (CG) Falls | 6 falls |
| Moving Together - PLWD | Caregiver (CG) Falls | 11 falls |
p-value: 0.377Poisson regression
Other Pre-specified
People With Memory Loss (PWML) Falls
Total number of falls reported for PWML in the entire group (not per participant).
Time frame: Baseline to 12 weeks
Population: Applies only to PLWD. Data missing for 2 Waitlist and 6 Moving Together participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Waitlist Control - PLWD | People With Memory Loss (PWML) Falls | 26 falls |
| Moving Together - PLWD | People With Memory Loss (PWML) Falls | 16 falls |
p-value: 0.043Poisson regression