Dementia
Conditions
Keywords
exercise, function, quality of life, caregiver
Brief summary
Preventing Loss of Independence through Exercise (PLIÉ) is a unique, multimodal movement program for people with dementia (affected individuals) that is taught by trained instructors and combines physical, mental and social activities. The Paired PLIÉ Program is an adapted version designed for pairs of affected individuals and care partners. The goal of this study is to perform a randomized, controlled trial (RCT) with a delayed start design to examine the effects of the Paired PLIÉ Program on function and quality of life in affected individuals and care partners.
Detailed description
Study participants are 30 pairs of individuals with mild-to-moderate dementia and their primary care partners (N=60 total) who are randomly assigned to Group 1 (immediate start) or Group 2 (delayed start). Pairs randomized to Group 1 participate together in the Paired PLIÉ program 2 days/week for 12 weeks (24 classes total) while pairs randomized to Group 2 continue with their usual activities. Then Group 1 transitions into a maintenance phase, and Group 2 participates in the Paired PLIÉ program 2 days/week for 12 weeks. Outcome data are collected in all study participants at baseline, mid-point and end-point so that we can examine the initial impact of the program as well as whether effects are maintained in Group 1. Outcome measures include cognitive function, physical performance, quality of life and caregiver well-being.
Interventions
The Paired PLIÉ Program is a novel, multimodal, movement program that focuses on abilities that are well maintained in people with dementia, including training procedural ('muscle') memory for basic daily movements, in-the-moment mindful body awareness, and social engagement. Group classes are held with affected individuals, care partners and instructors together. A monthly home visit also is provided.
After engaging in usual activities for 12 weeks, the Waitlist control group participates in the Paired PLIÉ program.
Sponsors
Study design
Eligibility
Inclusion criteria
Person with Cognitive Impairment * diagnosis of cognitive impairment or dementia * mild to moderate severity, defined as Clinical Dementia Rating of 0.5, 1 or 2 * willing and able to engage in study procedures * English language fluency Inclusion Criteria: Care Partner * provide care for person with cognitive impairment * willing and able to engage in study procedures * English language fluency
Exclusion criteria
Person with cognitive impairment * planning to miss more than 2 weeks during the study period * behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., drug abuse, severe mental health issues) * unable to take 2 steps independently without cane or walker * terminal illness (life expectancy \< 1 year) * currently participating in another research study that could impact current study * changes to dementia medications 3 months prior to baseline or changes planned during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function (PWCI, Direct Assessment) | 12 weeks | Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score This was was used to directly assess cognitive function in PWCI. It is one of the most commonly used outcome measures in dementia drug treatment trials. It includes direct assessment of learning (10-word list), naming (objects), following commands, constructional praxis (figure copying), ideational praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions. The ADAS-cog has shown high consistency and test-retest reliability. Higher scores (range 0-70) indicate worse cognitive function. |
| Physical Function (Affected Individual, Direct Assessment) | 12 weeks | Short Physical Performance Battery (SPPB) - total score The Short Physical Performance Battery (SPPB) was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. It includes direct assessment of lower body strength, balance and gait speed that provide a summary score (range 0-12). Higher scores indicate higher performance ability. |
| Quality of Life (Affected Individual, Self-report) | 12 weeks | Quality of life in Alzheimer's disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) asks PWDs to rate their current quality of life on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life. |
| Caregiver Burden (Caregiver, Self-report) | 12 weeks | Caregiver Burden Inventory (CBI) - total score This is a standard 24-item measure that includes questions about the CPs feelings about caregiving on a 5-point Likert scale with 5 domains. This measure has good internal consistency. Higher scores (range 0-96) indicate higher burden. |
| Cognitive Function (Affected Individual, Direct Assessment) | 24 weeks | Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to directly assess cognitive function in PWD. It is one of the most commonly used outcome measures in dementia drug treatment trials. It includes direct assessment of learning (10-word list), naming (objects), following commands, constructional praxis (figure copying), ideational praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions. The ADAS-cog has shown high consistency and test-retest reliability. Higher scores (range 0-70) indicate worse cognitive function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Falls Efficacy (Affected Individual, Caregiver Report) | 12 weeks | Falls Efficacy Scale (FES) - total score We administered a modified version of the Falls Efficacy Scale (FES) to assess concern about falling for the PWD in 10 different scenarios. Response categories used a 4-point Likert scale (range: 10 to 40), with higher scores indicating greater concern about falling (i.e., lower efficacy). Although the FES has been validated in individuals with cognitive impairment the questionnaire was administered separately to PWD and CPs to obtain their independent perspective |
| Quality of Life (Affected Individual, Caregiver Report) | 12 weeks | Quality of Life in Alzheimer's Disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) also asks CPs to rate the PWD current quality of life on the same scale as the PWD QOL self-report. It asks to rate their current quality of life on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life. |
| Mood (Caregiver, Self-report) | 12 weeks | Geriatric Depression Scale (GDS) - total score. The Geriatric Depression Scale (GDS) is a standard measure that includes 15 yes/no questions assessing depressive symptomatology over the past week. PWD and CP answered separately regarding their own mood. This scale ranges from 0 to 15 and has been validated in people with and without cognitive impairment. Higher scores indicate more depressive symptoms. |
| Independence (Affected Individual, Caregiver Report) | 12 weeks | Disability Assessment for Dementia (DAD) - total score Independence (PWD - CP report). The Disability Assessment for Dementia (DAD)is a standard measure that asks CPs to rate the participant's disability with 17 basic and 23 instrumental activities of daily living over the past 2 weeks. The DAD has high established validity and high test-retest reliability, inter-rater reliability, and internal consistency. Scores represent the percentage of activities performed independently during the past two weeks of those applicable (total number of questions answered yes/total questions applicable)∗100 with the range from 0 to 100. Higher scores indicate greater independence |
| Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report) | 24 weeks | Neuropsychiatric Inventory - Frequency/Severity (NPI-FS). For each behavior present, care partners are asked to rate the frequency (occasionally=1, often=2, frequently=3, very frequently=4) and severity (mild=1, moderate=2, severe=3). The score is obtained by multiplying frequency and severity and adding them for each behavior. Scores may range from 0 to 144 with higher scores indicating more frequent/severe behaviors. |
| Quality of Life (Person With Dementia, Caregiver Report) | 24 weeks | Quality of Life in Alzheimer's Disease (QOL-AD) - total score. Caregivers were asked to rate the QOL of participants with dementia on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life. |
| Feelings About Caregiving (Caregiver, Self-report) | 12 weeks | Positive Aspects of Caregiving (PAC) - total score. The PAC scale includes 9 questions about the benefits of caregiving noticed by the CPs about themselves, which are rated on a 5-point Likert scale. This measure has high internal consistency and can improve with CP training interventions. Total scores range from 11 to 55 with higher scores indicating more positive feelings. |
| Dementia-related Behaviors - Number (Affected Individual, Caregiver Report) | 12 weeks | The Neuropsychiatric Inventory (NPI) was administered to assess the number (NPI-N), caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) by CP report and has good test-retest reliability and internal consistency. NPI-N scores range from 0-12. Higher scores indicate worse outcomes (i.e., more behaviors, greater frequency/severity and greater distress). |
| Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report) | 12 weeks | Neuropsychiatric Inventory (NPI) - total frequency \* severity measures distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) by CP report and has good test-retest reliability and internal consistency. NPI-FS was calculated by multiplying the frequency∗severity of behaviors, which had a range of 0-144. Higher scores indicate worse outcomes (i.e., more behaviors, greater frequency/severity and greater distress). |
| Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report) | 12 weeks | Neuropsychiatric Inventory (NPI) - total distress level of caregiver distress (NPI-CD) caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) by CP report and has good test-retest reliability and internal consistency. NPI-CD range from 0-60. Higher scores indicate worse outcomes (i.e., more behaviors, greater frequency/severity and greater distress). |
| Falls Efficacy (Affected Individual, Self-report) | 12 weeks | Falls Efficacy Scale (FES) - total score We administered a modified version of the Falls Efficacy Scale (FES) to assess concern about falling for the PWD in 10 different scenarios. Response categories used a 4-point Likert scale (range: 10 to 40), with higher scores indicating greater concern about falling (i.e., lower efficacy). Although the FES has been validated in individuals with cognitive impairment the questionnaire was administered separately to PWD and CPs to obtain their independent perspetive |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited using a variety of strategies. We gave presentations at local caregiver support groups; distributed study flyers and brochures to psychiatrists, neurologists, and caregiver support managers; gave presentations at Medical Center Grand Rounds for attending physicians; and posted fliers in community settings and on social media (eg, Facebook).
Pre-assignment details
Exclusion criteria were behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., active psychosis, drug abuse, severe behavioral issues determined by interview); planning to move to a facility before the end of the study period; terminal illness (life expectancy.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Paired PLIÉ Program, immediate start
Paired PLIÉ Program: The Paired PLIÉ Program is a novel, multimodal, movement program that focuses on abilities that are well maintained in people with dementia, including training procedural ('muscle') memory for basic daily movements, in-the-moment mindful body awareness, and social engagement. Group classes are held with affected individuals, care partners and instructors together. A monthly home visit also is provided. | 30 |
| Group 2 Waitlist control
After engaging in usual activities for 12 weeks, the Waitlist control group participated in the Paired PLIÉ Program. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | Group 1 | Total | Group 2 |
|---|---|---|---|
| Age, Continuous | 71.6 years STANDARD_DEVIATION 9.7 | 60 years STANDARD_DEVIATION 13 | 59.1 years STANDARD_DEVIATION 17.4 |
| Balance score (SPPB) PWCI - direct assessment | 3.00 units on a scale STANDARD_DEVIATION 1.3 | 2.90 units on a scale STANDARD_DEVIATION 1.19 | 2.80 units on a scale STANDARD_DEVIATION 1.08 |
| Behaviors - distress (NPI-CD) CP - self-report | 4.29 units on a scale STANDARD_DEVIATION 3.43 | 7.01 units on a scale STANDARD_DEVIATION 7.86 | 9.73 units on a scale STANDARD_DEVIATION 12.29 |
| Behaviors - frequency (NPI-N) PWCI - CP report | 2.64 units on a scale STANDARD_DEVIATION 1.95 | 3.42 units on a scale STANDARD_DEVIATION 2.54 | 4.20 units on a scale STANDARD_DEVIATION 3.12 |
| Behaviors - severity (NPI-FS) PWCI - CP report | 7.57 units on a scale STANDARD_DEVIATION 6.17 | 10.57 units on a scale STANDARD_DEVIATION 10.54 | 13.57 units on a scale STANDARD_DEVIATION 14.9 |
| Caregiver burden (CBI) CP - self-report | 20.86 units on a scale STANDARD_DEVIATION 9.04 | 23.90 units on a scale STANDARD_DEVIATION 11.74 | 26.93 units on a scale STANDARD_DEVIATION 14.44 |
| Caregiving (PAC) CP - self-report | 41.93 units on a scale STANDARD_DEVIATION 5.97 | 42.8 units on a scale STANDARD_DEVIATION 7.54 | 43.67 units on a scale STANDARD_DEVIATION 9.1 |
| Cognitive function (ADAS-cog) PWCI - direct assessment | 32.21 units on a scale STANDARD_DEVIATION 11.62 | 30.81 units on a scale STANDARD_DEVIATION 10.5 | 29.40 units on a scale STANDARD_DEVIATION 9.38 |
| Falls Efficacy (FES) PWCI - CP report | 14.07 units on a scale STANDARD_DEVIATION 5.09 | 15.04 units on a scale STANDARD_DEVIATION 5.79 | 16.00 units on a scale STANDARD_DEVIATION 6.49 |
| Falls Efficacy (FES) PWCI - self-report | 12.43 units on a scale STANDARD_DEVIATION 3.44 | 12.65 units on a scale STANDARD_DEVIATION 4.5 | 12.87 units on a scale STANDARD_DEVIATION 5.55 |
| Independence (DAD) PWCI - CP report | 69.98 units on a scale STANDARD_DEVIATION 22.96 | 67.29 units on a scale STANDARD_DEVIATION 26.12 | 64.60 units on a scale STANDARD_DEVIATION 29.28 |
| Physical function (SPPB Score) PWCI - direct assessment | 6.86 units on a scale STANDARD_DEVIATION 2.66 | 6.70 units on a scale STANDARD_DEVIATION 2.37 | 6.53 units on a scale STANDARD_DEVIATION 2.07 |
| Quality of life (QOL-AD) PWCI - CP report | 35.86 units on a scale STANDARD_DEVIATION 3.37 | 35.13 units on a scale STANDARD_DEVIATION 4.01 | 34.40 units on a scale STANDARD_DEVIATION 4.64 |
| Quality of Life (QOL-AD) PWCI - self-report | 40.21 units on a scale STANDARD_DEVIATION 5.48 | 39.81 units on a scale STANDARD_DEVIATION 5.41 | 39.40 units on a scale STANDARD_DEVIATION 5.33 |
| Race (NIH/OMB) Care partners American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care partners Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Care partners Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Care partners More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care partners Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care partners Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Care partners White | 12 Participants | 20 Participants | 8 Participants |
| Race (NIH/OMB) Persons with cognitive impairment American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Persons with cognitive impairment Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Persons with cognitive impairment Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Persons with cognitive impairment More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Persons with cognitive impairment Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Persons with cognitive impairment Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Persons with cognitive impairment White | 14 Participants | 22 Participants | 8 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 30 participants |
| Sex: Female, Male Care partners Female | 10 Participants | 21 Participants | 11 Participants |
| Sex: Female, Male Care partners Male | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Participants with cognitive impairment Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Participants with cognitive impairment Male | 8 Participants | 14 Participants | 6 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 | 1 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 6 / 15 | 4 / 15 | 5 / 15 | 1 / 15 |
| serious Total, serious adverse events | 2 / 15 | 0 / 15 | 1 / 15 | 0 / 15 |
Outcome results
Caregiver Burden (Caregiver, Self-report)
Caregiver Burden Inventory (CBI) - total score Caregiver Burden Inventory (CBI) - total score This is a standard 24-item measure that includes questions about the CPs feelings about caregiving on a 5-point Likert scale with 5 domains. This measure has good internal consistency. Higher scores (range 0-96) indicate higher burden.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Caregiver Burden (Caregiver, Self-report) | 27.33 units on a scale | Standard Deviation 12.73 |
| Group 2 | Caregiver Burden (Caregiver, Self-report) | 30.00 units on a scale | Standard Deviation 16.64 |
Caregiver Burden (Caregiver, Self-report)
Caregiver Burden Inventory (CBI) - total score This is a standard 24-item measure that includes questions about the CPs feelings about caregiving on a 5-point Likert scale with 5 domains. This measure has good internal consistency. Higher scores (range 0-96) indicate higher burden.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Caregiver Burden (Caregiver, Self-report) | 23.27 units on a scale | Standard Deviation 11.2 |
| Group 2 | Caregiver Burden (Caregiver, Self-report) | 28.85 units on a scale | Standard Deviation 16.67 |
Cognitive Function (Affected Individual, Direct Assessment)
Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to directly assess cognitive function in PWD. It is one of the most commonly used outcome measures in dementia drug treatment trials. It includes direct assessment of learning (10-word list), naming (objects), following commands, constructional praxis (figure copying), ideational praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions. The ADAS-cog has shown high consistency and test-retest reliability. Higher scores (range 0-70) indicate worse cognitive function.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Cognitive Function (Affected Individual, Direct Assessment) | 30.97 units on a scale | Standard Deviation 11.46 |
| Group 2 | Cognitive Function (Affected Individual, Direct Assessment) | 32.67 units on a scale | Standard Deviation 11.48 |
Cognitive Function (PWCI, Direct Assessment)
Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) - total score This was was used to directly assess cognitive function in PWCI. It is one of the most commonly used outcome measures in dementia drug treatment trials. It includes direct assessment of learning (10-word list), naming (objects), following commands, constructional praxis (figure copying), ideational praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions. The ADAS-cog has shown high consistency and test-retest reliability. Higher scores (range 0-70) indicate worse cognitive function.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Cognitive Function (PWCI, Direct Assessment) | 31.78 units on a scale | Standard Deviation 11.15 |
| Group 2 | Cognitive Function (PWCI, Direct Assessment) | 32.60 units on a scale | Standard Deviation 13.62 |
Physical Function (Affected Individual, Direct Assessment)
Short Physical Performance Battery (SPPB) - total score The Short Physical Performance Battery (SPPB) was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. It includes direct assessment of lower body strength, balance and gait speed that provide a summary score (range 0-12). Higher scores indicate higher performance ability
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Physical Function (Affected Individual, Direct Assessment) | 6.70 units on a scale | Standard Deviation 2.26 |
| Group 2 | Physical Function (Affected Individual, Direct Assessment) | 6.69 units on a scale | Standard Deviation 2.36 |
Physical Function (Affected Individual, Direct Assessment)
Short Physical Performance Battery (SPPB) - total score The Short Physical Performance Battery (SPPB) was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. It includes direct assessment of lower body strength, balance and gait speed that provide a summary score (range 0-12). Higher scores indicate higher performance ability.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Physical Function (Affected Individual, Direct Assessment) | 6.50 units on a scale | Standard Deviation 2.32 |
| Group 2 | Physical Function (Affected Individual, Direct Assessment) | 6.57 units on a scale | Standard Deviation 2.5 |
Quality of Life (Affected Individual, Self-report)
Quality of life in Alzheimer's disease (QOL-AD) - total score Quality of life in Alzheimer's disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) asks PWDs to rate their current quality of life on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Quality of Life (Affected Individual, Self-report) | 41.20 units on a scale | Standard Deviation 5.45 |
| Group 2 | Quality of Life (Affected Individual, Self-report) | 40.85 units on a scale | Standard Deviation 5.81 |
Quality of Life (Affected Individual, Self-report)
Quality of life in Alzheimer's disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) asks PWDs to rate their current quality of life on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Quality of Life (Affected Individual, Self-report) | 41.42 units on a scale | Standard Deviation 4.74 |
| Group 2 | Quality of Life (Affected Individual, Self-report) | 40.14 units on a scale | Standard Deviation 5.8 |
Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)
Neuropsychiatric Inventory - caregiver distress (NPI-CD). For each behavior, caregivers are asked how emotionally distressing they find the behavior on a scale from 0 (not distressing at all) to 5 (extreme or very severe). Scores may range from 0 to 60 with higher scores indicating greater distress.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report) | 4.70 score on a scale | Standard Deviation 6.58 |
| Group 2 | Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report) | 9.64 score on a scale | Standard Deviation 10.68 |
Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)
Neuropsychiatric Inventory (NPI) - total distress level of caregiver distress (NPI-CD) caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) by CP report and has good test-retest reliability and internal consistency. NPI-CD range from 0-60. Higher scores indicate worse outcomes (i.e., more behaviors, greater frequency/severity and greater distress).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report) | 4.58 units on a scale | Standard Deviation 5 |
| Group 2 | Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report) | 11.21 units on a scale | Standard Deviation 12.58 |
Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report)
Neuropsychiatric Inventory - Frequency/Severity (NPI-FS). For each behavior present, care partners are asked to rate the frequency (occasionally=1, often=2, frequently=3, very frequently=4) and severity (mild=1, moderate=2, severe=3). The score is obtained by multiplying frequency and severity and adding them for each behavior. Scores may range from 0 to 144 with higher scores indicating more frequent/severe behaviors.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report) | 4.67 score on a scale | Standard Deviation 5.48 |
| Group 2 | Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report) | 12.54 score on a scale | Standard Deviation 11.16 |
Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)
The Neuropsychiatric Inventory (NPI) was administered to assess the number (NPI-N), caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) by CP report and has good test-retest reliability and internal consistency. NPI-N scores range from 0-12. Higher scores indicate worse outcomes (i.e., more behaviors, greater frequency/severity and greater distress).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Dementia-related Behaviors - Number (Affected Individual, Caregiver Report) | 2.25 units on a scale | Standard Deviation 1.82 |
| Group 2 | Dementia-related Behaviors - Number (Affected Individual, Caregiver Report) | 4.43 units on a scale | Standard Deviation 3.06 |
Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)
Neuropsychiatric Inventory (NPI) - total number of symptoms. The NPI asks CPs to report the number (NPI-N), frequency/severity (NPI-FS), and level of caregiver distress (NPI-CD) caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) and has good test-retest reliability and internal consistency. NPI-N scores range from 0-12.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Dementia-related Behaviors - Number (Affected Individual, Caregiver Report) | 2.20 count of symptoms | Standard Deviation 2.15 |
| Group 2 | Dementia-related Behaviors - Number (Affected Individual, Caregiver Report) | 3.93 count of symptoms | Standard Deviation 3.12 |
Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report)
Neuropsychiatric Inventory (NPI) - total frequency \* severity measures distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep, and appetite/eating) by CP report and has good test-retest reliability and internal consistency. NPI-FS was calculated by multiplying the frequency∗severity of behaviors, which had a range of 0-144. Higher scores indicate worse outcomes (i.e., more behaviors, greater frequency/severity and greater distress).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report) | 6.50 units on a scale | Standard Deviation 7.6 |
| Group 2 | Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report) | 15.69 units on a scale | Standard Deviation 16.03 |
Falls Efficacy (Affected Individual, Caregiver Report)
Falls Efficacy Scale (FES) - total score We administered a modified version of the Falls Efficacy Scale (FES) to assess concern about falling for the PWD in 10 different scenarios. Response categories used a 4-point Likert scale (range: 10 to 40), with higher scores indicating greater concern about falling (i.e., lower efficacy). Although the FES has been validated in individuals with cognitive impairment the questionnaire was administered separately to PWD and CPs to obtain their independent perspective
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Falls Efficacy (Affected Individual, Caregiver Report) | 14.17 units on a scale | Standard Deviation 5.87 |
| Group 2 | Falls Efficacy (Affected Individual, Caregiver Report) | 15.29 units on a scale | Standard Deviation 7.76 |
Falls Efficacy (Affected Individual, Caregiver Report)
Falls Efficacy Scale (FES) - total score. We administered a modified version of the FES to assess the caregiver's concern about the participant falling in 10 different scenarios. Response categories used a 4-point Likert scale (range: 10 to 40), with higher scores indicating greater concern about falling (i.e., lower efficacy).
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Falls Efficacy (Affected Individual, Caregiver Report) | 16.00 score on a scale | Standard Deviation 7.13 |
| Group 2 | Falls Efficacy (Affected Individual, Caregiver Report) | 16.14 score on a scale | Standard Deviation 6.7 |
Falls Efficacy (Affected Individual, Self-report)
Falls Efficacy Scale (FES) - total score We administered a modified version of the Falls Efficacy Scale (FES) to assess concern about falling for the PWD in 10 different scenarios. Response categories used a 4-point Likert scale (range: 10 to 40), with higher scores indicating greater concern about falling (i.e., lower efficacy). Although the FES has been validated in individuals with cognitive impairment the questionnaire was administered separately to PWD and CPs to obtain their independent perspetive
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Falls Efficacy (Affected Individual, Self-report) | 13.58 units on a scale | Standard Deviation 5.35 |
| Group 2 | Falls Efficacy (Affected Individual, Self-report) | 12.86 units on a scale | Standard Deviation 5.33 |
Falls Efficacy (Affected Individual, Self-report)
Falls Efficacy Scale (FES) - total score. We administered a modified version of the FES to assess the participant's concern about falling in 10 different scenarios. Response categories used a 4-point Likert scale (range: 10 to 40), with higher scores indicating greater concern about falling (i.e., lower efficacy).
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Falls Efficacy (Affected Individual, Self-report) | 13.40 score on a scale | Standard Deviation 4.48 |
| Group 2 | Falls Efficacy (Affected Individual, Self-report) | 15.93 score on a scale | Standard Deviation 9.22 |
Feelings About Caregiving (Caregiver, Self-report)
Positive Aspects of Caregiving (PAC) - total score. The PAC scale includes 9 questions about the benefits of caregiving noticed by the CPs about themselves, which are rated on a 5-point Likert scale. This measure has high internal consistency and can improve with CP training interventions. Total scores range from 11 to 55 with higher scores indicating more positive feelings.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Feelings About Caregiving (Caregiver, Self-report) | 43.50 units on a scale | Standard Deviation 7.2 |
| Group 2 | Feelings About Caregiving (Caregiver, Self-report) | 44.07 units on a scale | Standard Deviation 7.68 |
Feelings About Caregiving (Caregiver, Self-report)
Positive Aspects of Caregiving (PAC) - total score. The PAC includes 9 questions about the benefits of caregiving noticed by the CPs about themselves, which are rated on a 5-point Likert scale. This measure has high internal consistency and can improve with CP training interventions. Total scores range from 11 to 55 with higher scores indicating more positive feelings.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Feelings About Caregiving (Caregiver, Self-report) | 39.33 score on a scale | Standard Deviation 6.04 |
| Group 2 | Feelings About Caregiving (Caregiver, Self-report) | 42.93 score on a scale | Standard Deviation 8.41 |
Independence (Affected Individual, Caregiver Report)
Disability Assessment for Dementia (DAD) - total score Independence (PWD - CP report). The Disability Assessment for Dementia (DAD)is a standard measure that asks CPs to rate the participant's disability with 17 basic and 23 instrumental activities of daily living over the past 2 weeks. The DAD has high established validity and high test-retest reliability, inter-rater reliability, and internal consistency. Scores represent the percentage of activities performed independently during the past two weeks of those applicable (total number of questions answered yes/total questions applicable)∗100 with the range from 0 to 100. Higher scores indicate greater independence
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Independence (Affected Individual, Caregiver Report) | 23.27 units on a scale | Standard Deviation 11.2 |
| Group 2 | Independence (Affected Individual, Caregiver Report) | 28.85 units on a scale | Standard Deviation 16.67 |
Independence (Affected Individual, Caregiver Report)
Disability Assessment for Dementia (DAD) - total score. The DAD is a standard measure that asks CPs to rate the participant's disability with 17 basic and 23 instrumental activities of daily living over the past 2 weeks. The DAD has high established validity and high test-retest reliability, inter-rater reliability, and internal consistency. Scores represent the percentage of activities performed independently during the past two weeks of those applicable (total number of questions answered yes/total questions applicable)∗100 with the range from 0 to 100. Higher scores indicate greater independence.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Independence (Affected Individual, Caregiver Report) | 64.05 percentage of independence activities | Standard Deviation 24.97 |
| Group 2 | Independence (Affected Individual, Caregiver Report) | 59.04 percentage of independence activities | Standard Deviation 32.15 |
Mood (Caregiver, Self-report)
Geriatric Depression Scale (GDS) - total score. The Geriatric Depression Scale (GDS) is a standard measure that includes 15 yes/no questions assessing depressive symptomatology over the past week. PWD and CP answered separately regarding their own mood. This scale ranges from 0 to 15 and has been validated in people with and without cognitive impairment. Higher scores indicate more depressive symptoms.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Mood (Caregiver, Self-report) | 1.92 units on a scale | Standard Deviation 1.88 |
| Group 2 | Mood (Caregiver, Self-report) | 2.69 units on a scale | Standard Deviation 2.14 |
Mood (Caregiver, Self-report)
Geriatric Depression Scale (GDS) - total score. The GDS is a standard measure that includes 15 yes/no questions assessing depressive symptomatology over the past week. PWD and CP answered separately regarding their own mood. This scale ranges from 0 to 15 and has been validated in people with and without cognitive impairment. Higher scores indicate more depressive symptoms.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Mood (Caregiver, Self-report) | 2.22 score on a scale | Standard Deviation 1.2 |
| Group 2 | Mood (Caregiver, Self-report) | 2.57 score on a scale | Standard Deviation 2.77 |
Quality of Life (Affected Individual, Caregiver Report)
Quality of Life in Alzheimer's Disease (QOL-AD) - total score The Quality of Life Scale in Alzheimer's Disease (QOL-AD) also asks CPs to rate the PWD current quality of life on the same scale as the PWD QOL self-report. It asks to rate their current quality of life on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Quality of Life (Affected Individual, Caregiver Report) | 35.42 units on a scale | Standard Deviation 4.29 |
| Group 2 | Quality of Life (Affected Individual, Caregiver Report) | 33.00 units on a scale | Standard Deviation 7.12 |
Quality of Life (Person With Dementia, Caregiver Report)
Quality of Life in Alzheimer's Disease (QOL-AD) - total score. Caregivers were asked to rate the QOL of participants with dementia on a 4-point Likert scale (poor, fair, good, excellent) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Internal consistency is excellent with a Cronbach's alpha coefficient of 0.82. Higher scores (range 4-52) indicate higher quality of life.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Quality of Life (Person With Dementia, Caregiver Report) | 32.50 score on a scale | Standard Deviation 4.58 |
| Group 2 | Quality of Life (Person With Dementia, Caregiver Report) | 32.93 score on a scale | Standard Deviation 7.31 |