Skip to content

Paired Integrative Exercise Program for People With Dementia and Caregivers

Paired Integrative Exercise Program for People With Dementia and Caregivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02729311
Acronym
Paired PLIÉ
Enrollment
60
Registered
2016-04-06
Start date
2016-07-01
Completion date
2018-12-31
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

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

BEHAVIORALPaired 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.

BEHAVIORALWaitlist control

After engaging in usual activities for 12 weeks, the Waitlist control group participates in the Paired PLIÉ program.

Sponsors

Kaiser Permanente
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Cognitive Function (PWCI, Direct Assessment)12 weeksAlzheimer'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 weeksShort 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 weeksQuality 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 weeksCaregiver 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 weeksAlzheimer'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

MeasureTime frameDescription
Falls Efficacy (Affected Individual, Caregiver Report)12 weeksFalls 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 weeksQuality 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 weeksGeriatric 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 weeksDisability 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 weeksNeuropsychiatric 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 weeksQuality 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 weeksPositive 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 weeksThe 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 weeksNeuropsychiatric 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 weeksNeuropsychiatric 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 weeksFalls 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

ArmCount
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
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject82

Baseline characteristics

CharacteristicGroup 1TotalGroup 2
Age, Continuous71.6 years
STANDARD_DEVIATION 9.7
60 years
STANDARD_DEVIATION 13
59.1 years
STANDARD_DEVIATION 17.4
Balance score (SPPB) PWCI - direct assessment3.00 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-report4.29 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 report2.64 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 report7.57 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-report20.86 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-report41.93 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 assessment32.21 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 report14.07 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-report12.43 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 report69.98 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 assessment6.86 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 report35.86 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-report40.21 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 Participants0 Participants0 Participants
Race (NIH/OMB)
Care partners
Asian
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Care partners
Black or African American
2 Participants5 Participants3 Participants
Race (NIH/OMB)
Care partners
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Care partners
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Care partners
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Care partners
White
12 Participants20 Participants8 Participants
Race (NIH/OMB)
Persons with cognitive impairment
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Persons with cognitive impairment
Asian
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Persons with cognitive impairment
Black or African American
1 Participants4 Participants3 Participants
Race (NIH/OMB)
Persons with cognitive impairment
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Persons with cognitive impairment
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Persons with cognitive impairment
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Persons with cognitive impairment
White
14 Participants22 Participants8 Participants
Region of Enrollment
United States
30 participants30 participants30 participants
Sex: Female, Male
Care partners
Female
10 Participants21 Participants11 Participants
Sex: Female, Male
Care partners
Male
5 Participants9 Participants4 Participants
Sex: Female, Male
Participants with cognitive impairment
Female
7 Participants16 Participants9 Participants
Sex: Female, Male
Participants with cognitive impairment
Male
8 Participants14 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
1 / 150 / 150 / 150 / 15
other
Total, other adverse events
6 / 154 / 155 / 151 / 15
serious
Total, serious adverse events
2 / 150 / 151 / 150 / 15

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Caregiver Burden (Caregiver, Self-report)27.33 units on a scaleStandard Deviation 12.73
Group 2Caregiver Burden (Caregiver, Self-report)30.00 units on a scaleStandard Deviation 16.64
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Caregiver Burden (Caregiver, Self-report)23.27 units on a scaleStandard Deviation 11.2
Group 2Caregiver Burden (Caregiver, Self-report)28.85 units on a scaleStandard Deviation 16.67
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Cognitive Function (Affected Individual, Direct Assessment)30.97 units on a scaleStandard Deviation 11.46
Group 2Cognitive Function (Affected Individual, Direct Assessment)32.67 units on a scaleStandard Deviation 11.48
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Cognitive Function (PWCI, Direct Assessment)31.78 units on a scaleStandard Deviation 11.15
Group 2Cognitive Function (PWCI, Direct Assessment)32.60 units on a scaleStandard Deviation 13.62
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Physical Function (Affected Individual, Direct Assessment)6.70 units on a scaleStandard Deviation 2.26
Group 2Physical Function (Affected Individual, Direct Assessment)6.69 units on a scaleStandard Deviation 2.36
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Physical Function (Affected Individual, Direct Assessment)6.50 units on a scaleStandard Deviation 2.32
Group 2Physical Function (Affected Individual, Direct Assessment)6.57 units on a scaleStandard Deviation 2.5
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Quality of Life (Affected Individual, Self-report)41.20 units on a scaleStandard Deviation 5.45
Group 2Quality of Life (Affected Individual, Self-report)40.85 units on a scaleStandard Deviation 5.81
Primary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Quality of Life (Affected Individual, Self-report)41.42 units on a scaleStandard Deviation 4.74
Group 2Quality of Life (Affected Individual, Self-report)40.14 units on a scaleStandard Deviation 5.8
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)4.70 score on a scaleStandard Deviation 6.58
Group 2Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)9.64 score on a scaleStandard Deviation 10.68
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)4.58 units on a scaleStandard Deviation 5
Group 2Dementia-related Behaviors - Caregiver Distress (Caregiver, Self-report)11.21 units on a scaleStandard Deviation 12.58
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report)4.67 score on a scaleStandard Deviation 5.48
Group 2Dementia-related Behaviors - Frequency and Severity (Affected Individual, Caregiver Report)12.54 score on a scaleStandard Deviation 11.16
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)2.25 units on a scaleStandard Deviation 1.82
Group 2Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)4.43 units on a scaleStandard Deviation 3.06
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)2.20 count of symptomsStandard Deviation 2.15
Group 2Dementia-related Behaviors - Number (Affected Individual, Caregiver Report)3.93 count of symptomsStandard Deviation 3.12
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report)6.50 units on a scaleStandard Deviation 7.6
Group 2Dementia-related Behaviors - Severity (Affected Individual, Caregiver Report)15.69 units on a scaleStandard Deviation 16.03
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Falls Efficacy (Affected Individual, Caregiver Report)14.17 units on a scaleStandard Deviation 5.87
Group 2Falls Efficacy (Affected Individual, Caregiver Report)15.29 units on a scaleStandard Deviation 7.76
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Falls Efficacy (Affected Individual, Caregiver Report)16.00 score on a scaleStandard Deviation 7.13
Group 2Falls Efficacy (Affected Individual, Caregiver Report)16.14 score on a scaleStandard Deviation 6.7
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Falls Efficacy (Affected Individual, Self-report)13.58 units on a scaleStandard Deviation 5.35
Group 2Falls Efficacy (Affected Individual, Self-report)12.86 units on a scaleStandard Deviation 5.33
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Falls Efficacy (Affected Individual, Self-report)13.40 score on a scaleStandard Deviation 4.48
Group 2Falls Efficacy (Affected Individual, Self-report)15.93 score on a scaleStandard Deviation 9.22
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Feelings About Caregiving (Caregiver, Self-report)43.50 units on a scaleStandard Deviation 7.2
Group 2Feelings About Caregiving (Caregiver, Self-report)44.07 units on a scaleStandard Deviation 7.68
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Feelings About Caregiving (Caregiver, Self-report)39.33 score on a scaleStandard Deviation 6.04
Group 2Feelings About Caregiving (Caregiver, Self-report)42.93 score on a scaleStandard Deviation 8.41
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Independence (Affected Individual, Caregiver Report)23.27 units on a scaleStandard Deviation 11.2
Group 2Independence (Affected Individual, Caregiver Report)28.85 units on a scaleStandard Deviation 16.67
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Independence (Affected Individual, Caregiver Report)64.05 percentage of independence activitiesStandard Deviation 24.97
Group 2Independence (Affected Individual, Caregiver Report)59.04 percentage of independence activitiesStandard Deviation 32.15
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Mood (Caregiver, Self-report)1.92 units on a scaleStandard Deviation 1.88
Group 2Mood (Caregiver, Self-report)2.69 units on a scaleStandard Deviation 2.14
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Mood (Caregiver, Self-report)2.22 score on a scaleStandard Deviation 1.2
Group 2Mood (Caregiver, Self-report)2.57 score on a scaleStandard Deviation 2.77
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Quality of Life (Affected Individual, Caregiver Report)35.42 units on a scaleStandard Deviation 4.29
Group 2Quality of Life (Affected Individual, Caregiver Report)33.00 units on a scaleStandard Deviation 7.12
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Group 1Quality of Life (Person With Dementia, Caregiver Report)32.50 score on a scaleStandard Deviation 4.58
Group 2Quality of Life (Person With Dementia, Caregiver Report)32.93 score on a scaleStandard Deviation 7.31

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026