Alzheimer Disease
Conditions
Keywords
Physical Activity, Exercise
Brief summary
The objective of this study is to compare the effectiveness of 2 intervention delivery strategies for increasing moderate physical activity (MPA), real-time group video conferencing (RGV) vs. enhanced usual care (EUC), in community dwelling adults with Alzheimer's diseases (AD) and their caregiver (dyads) over 18 mos. (6 mos. active, 6 mos. maintenance, 6 mos. no contact). The primary outcome is to compare total MPA (min/wk.), assessed using ActiGraph, in adults with AD from baseline to 6 mos. Secondary aims for the Adults with AD are to compare MPA (min/wk), sedentary time (min/wk.), percentage meeting 150 min/wk. goal, functional fitness, activities of daily living (basic/instrumental), quality of life, residential transitions, and cognitive function across 18 months between RGV and EUC. Secondary aims for the caregivers are to compare total MPA (min/wk.), sedentary time (min/wk.), functional fitness, quality of life, caregiver burden across 18 months between RGV and EUC. Additionally, as an exploratory aim, this study will evaluate the influence of process variables/participant characteristics on MPA in adults with AD and their caregiver across 6, 12 & 18 mos.: age, sex, BMI, attendance (exercise/support sessions), use of recorded videos, PA self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers.
Detailed description
This study will compare 2 strategies for the delivery of an intervention to increase moderate physical activity (MPA) in community dwelling adults with AD and their caregiver (dyads); real-time group video conferencing (RGV) vs. enchanced usual care (EUC). Adults (age ≥ 55 yrs.) with mild to moderate AD (n=100) and their caregiver (n=100) will be randomized (1:1) to one of the 2 intervention arms for an 18-mo. trial (6 mos. active intervention, 6 mos. maintenance, 6 mos no contact). Cohorts of \ 20 dyads will be recruited and computer randomized. Dyads will be stratified by the sex of the person with AD, and sequentially randomized by the study statistician with equal allocation to the RGV or EUC arms. Participants in both arms will be provided with an iPad® for intervention delivery, Fitbit (Fitbit Inc., San Francisco, CA) for self-monitoring MPA, and will be asked to complete 150 min of MPA/wk. Dyads in the RGV arm will be asked to complete three 45 min sessions that include aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home. Dyads in the EUC arm, will be given a recommended exercise plan to follow own their own. Dyads in both arms will be provided with written materials regarding exercise and physical activity from the National Institute on Aging and will be asked to complete brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary outcome, total MPA, will be assessed, in both individuals with AD and caregivers, by Actigraph at baseline, 3, 6, 12 & 18 mos. All secondary/exploratory outcomes will be assessed at the individual with AD or caregivers' home at baselines, 6, 12, and 18 months. Secondary outcomes for the individual with AD are sedentary time, functional fitness, activities of daily living, quality of life, residential transition, and cognitive function. Secondary outcomes for the caregiver are sedentary time, functional fitness, quality of life, and caregiver burden. The exploratory outcomes are age, sex, BMI, attendance (exercise/support sessions), use of pre-recorded videos, PA self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers. This trial is powered to detect a between-arm difference (RGV vs. EUC) of 10 min./d. in MPA. This difference represents additional 70 mins. of MPA/wk. in the RGV arm. Power analysis shows that 84 participants (42/arm) would provide 81% power to test an overall between-arm difference across time, i.e., group effect. This sample size would also provide ≥ 80% power to detect a between-arm difference in change, i.e., group-by-time interaction, as small as f = 0.10. Thus, conservatively assuming a high attrition rate of 20%, the study team will recruit 100 dyads at baseline to assure the final sample size requirements are achieved, i.e., final N ≥ 84 (thus, power ≥ 80%) with attrition up to 20%. General mixed modeling for repeated measures will be utilized to evaluate the primary aim to compare total MPA (min/wk.) across the 6 mo. active intervention in adults with AD and their caregiver randomized to the RGV and EUC interventions. A similar mixed modeling analysis will be conducted to examine the secondary aim. General mixed models will be fitted for the two arms combined to examine the association for the process variables/participant characteristics with MPA. However, if there is a significant between-arm difference in MPA, the investigators will determine whether the process variables/participant characteristics amplify or attenuate the RGV effect, i.e., moderation, by testing a 2-way interaction with the group effect and/or a 3-way interaction with the group-by-time interaction term.
Interventions
BEHAVIORALReal-time Group Video
Dyads in the RGV arm will be asked to complete three 45 min sessions that include aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.
BEHAVIORALEnhanced Usual Care
Dyads in the EUC arm, will be given a recommended exercise plan to follow on their own along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.
Sponsors
National Institute on Aging (NIA)
University of Kansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with AD - 1. Very mild to moderate dementia 2. Age ≥ 55 yrs 3. Low-risk of falls 4. Ability to participate in MPA, e.g., walk including with an assistive device, as verified PCP clearance. 5. Ability to communicate verbally. 6. Vision and hearing sufficient to safely comply with the intervention program as verified by PCP clearance. 7. Reside at home and receive support from a caregiver. 8. Internet access in the home. Caregivers- 1. Age ≥18 yrs. 2. Spends at least 20 hrs./wk. with the adult with AD.
Exclusion criteria
Adults with AD- 1. Current exercise, i.e., \> 3, 30-min bouts of planned exercise/wk. 2. Clinically significant psychiatric disorder; systemic illness or infection likely to affect safety; clinically-evident stroke; myocardial infarction or coronary artery disease in the last 2 yrs.; cancer in the last 5 yrs.; or significant pain or musculoskeletal symptoms that would prohibit exercise. 3. Unwilling to be randomized. Caregivers- 1. Unable to participate in MPA, i.e., brisk walking. 2. Unwilling to be randomized. 3. Serious medical risk, such as cancer within the last 5 yrs. or cardiac event, i.e., heart attack, stroke, angioplasty within the last 2 yrs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate Physical Activity | Baseline to 18 months | Moderate physical activity will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 3, 6, 12 and 18 months. The ActiGraph wGT3x-BT is worn on a belt on the non-dominant hip during all waking hours for one week (7 consecutive days), with the exception of bathing, and swimming. The device measures acceleration. The acceleration values are used to determine levels of physical activity using previously validated cutpoints. Data were considered valid if they wore the accelerometer for at least 8 hours on 3 days, including 1 weekend day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activities of Daily Living | Baseline to 18 months | Activities of daily living will be assessed at baseline, 6, 12 and 18 months using the Disabilities Assessment for Dementia (DAD). The DAD includes 40 items: 17 related to basic self-care and 23 to instrumental activities of daily living. Scores range from 0-40, with higher scores indicating less disability. |
| Change in Quality of Life | Baseline to 18 months | Quality of life will be assessed at baseline to 18 months using the QOL-AD, a brief, 13-item self-report and 15-item caregiver-report. Each item is rated on a scale from 1-4, 1=Poor, 2=Fair, 3=Good, 4=Excellent. Scores range from 13-52, with larger numbers indicating better quality of life. |
| Residential Transitions | Baseline to 18 months | Residential transitions, i.e., from home to institutional care, will be tracked by health coaches. Caregiver desire to institutionalize the adult with AD will be assessed using the 6-item Morycz's Desire-to-Institutionalize Scale |
| Cognitive Function | Baseline to 18 months | Cognitive function will be assessed at baseline, 6, 12 and 18 months using Applied Cognition Abilities 4a instruments from the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Battery. Both test contain 4 questions that will be answered by the adult with AD. Scores range from 0-100, with higher scores indicating better cognitive function. |
| Caregiver Sedentary Time | Baseline to 18 months | Caregiver sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months. |
| Caregiver Functional Fitness | Baseline to 18 months | Caregiver functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching. |
| Caregiver Quality of Life | Baseline to 18 months | Caregiver quality of life will be assessed at baseline, 6, 12 and 18 months using the SF-36, which involves 36 questions relating to quality of life in typically developed adults. Scores range from 0-100, with higher score indicates better health. |
| Caregiver Burden | Baseline to 18 months | Caregiver Burden will be assessed at baseline, 6, 12 and 18 months using the Zarit Burden Interview-short version, a 12-item self-report questionnaire in which the caregiver is asked to answer using a 5-point scale. Scores range from 0-48, with lower scores indicating less caregiver burden. |
| Sedentary Time | Baseline to 18 months | Sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months. |
| Functional Fitness | Baseline to 18 months | Functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of Recorded Videos | Baseline to 18 months | Use of recorded videos including frequency and duration of access (RGV only) will be assessed using Dropbox® analytics. |
| Self-monitoring of Physical Activity | Baseline to 18 months | Self-monitoring of physical activity will be assessed as the percentage of days with Fitbit data over a minimum of 8 hrs., between 6 am and midnight |
| Caregiver Support | Baseline to 18 months | Caregiver support will be assessed using the percentage of group exercise sessions (RGV) and/ or individual support sessions completed by both the person with AD and their caregiver. |
| Peer Interactions (RGV Only) | Baseline to 18 months | Staff will review video recordings of a random sample of 33% of group exercise sessions to identify and classify both peer to peer, and health coach to participant interactions. Interactions will be quantified and coded as verbal/non-verbal (waving, pointing, shaking head in agreement/disagreement), and as positive, neutral or negative, relative to support. |
| Quality of the Dyadic Relationship | Baseline to 18 months | Quality of the dyadic relationship will be assessed at baseline, 6, 12, and 18 mos. using the dyadic relationship scale (DRS) which measures negative and positive dyadic interactions from the perspective of both the patient and the caregiver. Scores range from 1-6, with higher scores indicating more positive dyadic relationships. |
| Body Mass Index | Baseline to 18 months | Weight will be measured in duplicate at baseline, 6, 12 and 18 months in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg. Standing height will be measured at baseline, 6, 12 and 18 months in duplicate with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK). BMI will be calculated as weight (kg)/height (m2). |
| Session Attendance | Baseline to 18 months | Session attendance for group exercise (RGV only) and support sessions will be obtained from records maintained by the health coach, and expressed as the percent of possible sessions from 0-6 mos. and 7-12 mos. Attendance for adults with AD, enrolled caregivers, and alternative caregivers will be recorded separately. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Real-time Group Video: Alzheimer's Patient Alzheimer's Patients randomized to the RGV arm were asked to complete three 45 min sessions that include aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA. | 57 |
| Real-time Group Video: Caregiver Caregivers of Alzheimer's patients randomized to the Real-time Group Video arm attended three 45 min sessions with the Alzheimer's Patient that included aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA. | 57 |
| Enhanced Usual Care: Alzheimer's Patient Alzheimer's Patients in the EUC arm, were given a recommended exercise plan to follow on their own along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA. | 42 |
| Enhanced Usual Care: Caregiver Caregivers in the EUC arm, assisted the Alzheimer's Patient with increasing MPA and were given a recommended exercise plan to follow on their own along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA. | 42 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 3 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 3 | 0 |
| Overall Study | Moved to longterm care facility | 6 | 0 | 4 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 13 | 7 | 14 |
Baseline characteristics
| Characteristic | Real-time Group Video: Alzheimer's Patient | Real-time Group Video: Caregiver | Enhanced Usual Care: Alzheimer's Patient | Enhanced Usual Care: Caregiver | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 41 Participants | 38 Participants | 33 Participants | 160 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 16 Participants | 4 Participants | 9 Participants | 38 Participants |
| Age, Continuous | 72.0 years STANDARD_DEVIATION 8 | 68.5 years STANDARD_DEVIATION 11.8 | 75.8 years STANDARD_DEVIATION 8.6 | 69.7 years STANDARD_DEVIATION 12.1 | 73.5 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 3 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 56 Participants | 39 Participants | 38 Participants | 189 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 53 Participants | 40 Participants | 40 Participants | 186 Participants |
| Region of Enrollment United States | 57 participants | 57 participants | 42 participants | 42 participants | 198 participants |
| Sex: Female, Male Female | 23 Participants | 38 Participants | 16 Participants | 31 Participants | 108 Participants |
| Sex: Female, Male Male | 34 Participants | 19 Participants | 26 Participants | 11 Participants | 90 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 | 3 / 57 | 0 / 57 | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 28 / 57 | 23 / 57 | 21 / 42 | 6 / 42 |
| serious Total, serious adverse events | 9 / 57 | 6 / 57 | 7 / 42 | 1 / 42 |
Outcome results
Primary
Moderate Physical Activity
Moderate physical activity will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 3, 6, 12 and 18 months. The ActiGraph wGT3x-BT is worn on a belt on the non-dominant hip during all waking hours for one week (7 consecutive days), with the exception of bathing, and swimming. The device measures acceleration. The acceleration values are used to determine levels of physical activity using previously validated cutpoints. Data were considered valid if they wore the accelerometer for at least 8 hours on 3 days, including 1 weekend day.
Time frame: Baseline to 18 months
Population: Overall number of participants differs from Number analyzed below due to patients and caregivers not meeting wear-time criteria for valid data. Only those with valid wear-time were included in analysis. Additionally, participant/caregiver withdrawal resulted in differing numbers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Moderate Physical Activity | Month 12 Moderate Physical Activity | 10.8 minutes per day | Standard Deviation 15.1 |
| Real-time Group Video: Alzheimer's Patient | Moderate Physical Activity | Month 3 Moderate Physical Activity | 14.7 minutes per day | Standard Deviation 16.5 |
| Real-time Group Video: Alzheimer's Patient | Moderate Physical Activity | Month 18 Moderate Physical Activity | 12.6 minutes per day | Standard Deviation 18.4 |
| Real-time Group Video: Alzheimer's Patient | Moderate Physical Activity | Month 6 Moderate Physical Activity | 11.6 minutes per day | Standard Deviation 12.9 |
| Real-time Group Video: Alzheimer's Patient | Moderate Physical Activity | Baseline Moderate Physical Activity | 13.3 minutes per day | Standard Deviation 13.2 |
| Real-time Group Video: Caregiver | Moderate Physical Activity | Month 6 Moderate Physical Activity | 22.6 minutes per day | Standard Deviation 21.1 |
| Real-time Group Video: Caregiver | Moderate Physical Activity | Month 12 Moderate Physical Activity | 23.6 minutes per day | Standard Deviation 23.5 |
| Real-time Group Video: Caregiver | Moderate Physical Activity | Month 18 Moderate Physical Activity | 20.9 minutes per day | Standard Deviation 22.7 |
| Real-time Group Video: Caregiver | Moderate Physical Activity | Month 3 Moderate Physical Activity | 25.1 minutes per day | Standard Deviation 23.2 |
| Real-time Group Video: Caregiver | Moderate Physical Activity | Baseline Moderate Physical Activity | 20.7 minutes per day | Standard Deviation 17.5 |
| Enhanced Usual Care: Alzheimer's Patient | Moderate Physical Activity | Month 6 Moderate Physical Activity | 14.1 minutes per day | Standard Deviation 17.7 |
| Enhanced Usual Care: Alzheimer's Patient | Moderate Physical Activity | Baseline Moderate Physical Activity | 14.4 minutes per day | Standard Deviation 17.3 |
| Enhanced Usual Care: Alzheimer's Patient | Moderate Physical Activity | Month 3 Moderate Physical Activity | 11.7 minutes per day | Standard Deviation 14.2 |
| Enhanced Usual Care: Alzheimer's Patient | Moderate Physical Activity | Month 12 Moderate Physical Activity | 12.5 minutes per day | Standard Deviation 15.1 |
| Enhanced Usual Care: Alzheimer's Patient | Moderate Physical Activity | Month 18 Moderate Physical Activity | 16.1 minutes per day | Standard Deviation 18.5 |
| Enhanced Usual Care: Caregiver | Moderate Physical Activity | Month 12 Moderate Physical Activity | 19.4 minutes per day | Standard Deviation 15.2 |
| Enhanced Usual Care: Caregiver | Moderate Physical Activity | Month 3 Moderate Physical Activity | 23.7 minutes per day | Standard Deviation 21.9 |
| Enhanced Usual Care: Caregiver | Moderate Physical Activity | Baseline Moderate Physical Activity | 19.3 minutes per day | Standard Deviation 19.5 |
| Enhanced Usual Care: Caregiver | Moderate Physical Activity | Month 6 Moderate Physical Activity | 21.1 minutes per day | Standard Deviation 21.5 |
| Enhanced Usual Care: Caregiver | Moderate Physical Activity | Month 18 Moderate Physical Activity | 29.6 minutes per day | Standard Deviation 21.9 |
Secondary
Activities of Daily Living
Activities of daily living will be assessed at baseline, 6, 12 and 18 months using the Disabilities Assessment for Dementia (DAD). The DAD includes 40 items: 17 related to basic self-care and 23 to instrumental activities of daily living. Scores range from 0-40, with higher scores indicating less disability.
Time frame: Baseline to 18 months
Population: Number Analyzed differs from overall analyzed due to participant drops and non-returned data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Activities of Daily Living | Baseline Activities of Daily Living | 34.0 score on a scale | Standard Deviation 8.8 |
| Real-time Group Video: Alzheimer's Patient | Activities of Daily Living | 6 Month Activities of Daily Living | 31.3 score on a scale | Standard Deviation 11.8 |
| Real-time Group Video: Alzheimer's Patient | Activities of Daily Living | 12 Month Activities of Daily Living | 28.2 score on a scale | Standard Deviation 12.4 |
| Real-time Group Video: Alzheimer's Patient | Activities of Daily Living | 18 Month Activities of Daily Living | 29.0 score on a scale | Standard Deviation 14.7 |
| Real-time Group Video: Caregiver | Activities of Daily Living | 18 Month Activities of Daily Living | 32.7 score on a scale | Standard Deviation 12.8 |
| Real-time Group Video: Caregiver | Activities of Daily Living | Baseline Activities of Daily Living | 30.8 score on a scale | Standard Deviation 12.4 |
| Real-time Group Video: Caregiver | Activities of Daily Living | 12 Month Activities of Daily Living | 29.3 score on a scale | Standard Deviation 10.2 |
| Real-time Group Video: Caregiver | Activities of Daily Living | 6 Month Activities of Daily Living | 28.7 score on a scale | Standard Deviation 11.6 |
Secondary
Caregiver Burden
Caregiver Burden will be assessed at baseline, 6, 12 and 18 months using the Zarit Burden Interview-short version, a 12-item self-report questionnaire in which the caregiver is asked to answer using a 5-point scale. Scores range from 0-48, with lower scores indicating less caregiver burden.
Time frame: Baseline to 18 months
Population: Number analyzed differs from overall due to participant drops and non-returned data. Measure was collected from Caregivers only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Caregiver Burden | Baseline Caregiver Burden | 1.75 score on a scale | Standard Deviation 0.94 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Burden | 6 Month Caregiver Burden | 1.5 score on a scale | Standard Deviation 0.97 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Burden | 12 Month Caregiver Burden | 1.53 score on a scale | Standard Deviation 0.97 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Burden | 18 Month Caregiver Burden | 1.93 score on a scale | Standard Deviation 1.07 |
| Real-time Group Video: Caregiver | Caregiver Burden | 18 Month Caregiver Burden | 1.28 score on a scale | Standard Deviation 1.02 |
| Real-time Group Video: Caregiver | Caregiver Burden | Baseline Caregiver Burden | 1.49 score on a scale | Standard Deviation 1.02 |
| Real-time Group Video: Caregiver | Caregiver Burden | 12 Month Caregiver Burden | 1.52 score on a scale | Standard Deviation 0.95 |
| Real-time Group Video: Caregiver | Caregiver Burden | 6 Month Caregiver Burden | 1.53 score on a scale | Standard Deviation 0.86 |
Secondary
Caregiver Functional Fitness
Caregiver functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching.
Time frame: Baseline to 18 months
Population: Number Analyzed differs from baseline at subsequent timepoints due to participant drops and missed data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Caregiver Functional Fitness | Baseline Step Test | 80.2 Reptetitions | Standard Deviation 22 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Functional Fitness | 6 Month Step Test | 94.7 Reptetitions | Standard Deviation 25.8 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Functional Fitness | 12 Month Step Test | 93.9 Reptetitions | Standard Deviation 28.7 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Functional Fitness | 18 Month Step Test | 96.4 Reptetitions | Standard Deviation 25.7 |
| Real-time Group Video: Caregiver | Caregiver Functional Fitness | 18 Month Step Test | 92.4 Reptetitions | Standard Deviation 22.1 |
| Real-time Group Video: Caregiver | Caregiver Functional Fitness | Baseline Step Test | 80.0 Reptetitions | Standard Deviation 20.5 |
| Real-time Group Video: Caregiver | Caregiver Functional Fitness | 12 Month Step Test | 87.1 Reptetitions | Standard Deviation 20.3 |
| Real-time Group Video: Caregiver | Caregiver Functional Fitness | 6 Month Step Test | 84.3 Reptetitions | Standard Deviation 19.4 |
Secondary
Caregiver Quality of Life
Caregiver quality of life will be assessed at baseline, 6, 12 and 18 months using the SF-36, which involves 36 questions relating to quality of life in typically developed adults. Scores range from 0-100, with higher score indicates better health.
Time frame: Baseline to 18 months
Population: Number analyzed below differs from overall number due to participant drops and non-returned data. Measure only collected from Caregivers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Caregiver Quality of Life | Baseline Caregiver Quality of Life | 36.4 score on a scale | Standard Deviation 5.8 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Quality of Life | 6 Month Caregiver Quality of Life | 36.4 score on a scale | Standard Deviation 7.1 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Quality of Life | 12 Month Caregiver Quality of Life | 36.6 score on a scale | Standard Deviation 6.5 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Quality of Life | 18 Month Caregiver Quality of Life | 34.1 score on a scale | Standard Deviation 6 |
| Real-time Group Video: Caregiver | Caregiver Quality of Life | 18 Month Caregiver Quality of Life | 38.1 score on a scale | Standard Deviation 7.7 |
| Real-time Group Video: Caregiver | Caregiver Quality of Life | Baseline Caregiver Quality of Life | 37.0 score on a scale | Standard Deviation 7.4 |
| Real-time Group Video: Caregiver | Caregiver Quality of Life | 12 Month Caregiver Quality of Life | 37.9 score on a scale | Standard Deviation 6.8 |
| Real-time Group Video: Caregiver | Caregiver Quality of Life | 6 Month Caregiver Quality of Life | 36.3 score on a scale | Standard Deviation 6 |
Secondary
Caregiver Sedentary Time
Caregiver sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months.
Time frame: Baseline to 18 months
Population: Overall number of participants differs from Number analyzed below due to patients and caregivers not meeting wear-time criteria for valid data. Only those with valid wear-time were included in analysis. Additionally, participant/caregiver withdrawal resulted in differing numbers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Caregiver Sedentary Time | Baseline Sedentary Time | 525.1 minutes per day | Standard Deviation 143.7 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Sedentary Time | 12 Month Sedentary Time | 521.2 minutes per day | Standard Deviation 116.9 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Sedentary Time | 6 Month Sedentary Time | 518.7 minutes per day | Standard Deviation 131.4 |
| Real-time Group Video: Alzheimer's Patient | Caregiver Sedentary Time | 18 Month Sedentary Time | 517.9 minutes per day | Standard Deviation 109.6 |
| Real-time Group Video: Caregiver | Caregiver Sedentary Time | 18 Month Sedentary Time | 571.2 minutes per day | Standard Deviation 386.7 |
| Real-time Group Video: Caregiver | Caregiver Sedentary Time | Baseline Sedentary Time | 526.9 minutes per day | Standard Deviation 123.7 |
| Real-time Group Video: Caregiver | Caregiver Sedentary Time | 6 Month Sedentary Time | 526.0 minutes per day | Standard Deviation 141.2 |
| Real-time Group Video: Caregiver | Caregiver Sedentary Time | 12 Month Sedentary Time | 542.1 minutes per day | Standard Deviation 138.9 |
Secondary
Change in Quality of Life
Quality of life will be assessed at baseline to 18 months using the QOL-AD, a brief, 13-item self-report and 15-item caregiver-report. Each item is rated on a scale from 1-4, 1=Poor, 2=Fair, 3=Good, 4=Excellent. Scores range from 13-52, with larger numbers indicating better quality of life.
Time frame: Baseline to 18 months
Population: Number analyzed differs from overall participants due to participant drops and non-returned surveys. Measure only pertained to Alzheimer's Patient.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Change in Quality of Life | Baseline Quality of Life | 37.59 Score on a scale | Standard Deviation 4.92 |
| Real-time Group Video: Alzheimer's Patient | Change in Quality of Life | 6 Month Quality of Life | 38.83 Score on a scale | Standard Deviation 5.78 |
| Real-time Group Video: Alzheimer's Patient | Change in Quality of Life | 12 Month Quality of Life | 37.93 Score on a scale | Standard Deviation 5.09 |
| Real-time Group Video: Alzheimer's Patient | Change in Quality of Life | 18 Month Quality of Life | 36.71 Score on a scale | Standard Deviation 5.06 |
| Real-time Group Video: Caregiver | Change in Quality of Life | 18 Month Quality of Life | 38.30 Score on a scale | Standard Deviation 3.82 |
| Real-time Group Video: Caregiver | Change in Quality of Life | Baseline Quality of Life | 38.61 Score on a scale | Standard Deviation 5.03 |
| Real-time Group Video: Caregiver | Change in Quality of Life | 12 Month Quality of Life | 38.81 Score on a scale | Standard Deviation 4.94 |
| Real-time Group Video: Caregiver | Change in Quality of Life | 6 Month Quality of Life | 38.75 Score on a scale | Standard Deviation 4.29 |
Secondary
Cognitive Function
Cognitive function will be assessed at baseline, 6, 12 and 18 months using Applied Cognition Abilities 4a instruments from the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Battery. Both test contain 4 questions that will be answered by the adult with AD. Scores range from 0-100, with higher scores indicating better cognitive function.
Time frame: Baseline to 18 months
Population: Number analyzed below differs from overall due to participant drops and non-returned data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Cognitive Function | Baseline Cognitive Function | 38.6 score on a scale | Standard Deviation 13.9 |
| Real-time Group Video: Alzheimer's Patient | Cognitive Function | 6 Month Cognitive Function | 27.3 score on a scale | Standard Deviation 19.1 |
| Real-time Group Video: Alzheimer's Patient | Cognitive Function | 12 Month Cognitive Function | 31.8 score on a scale | Standard Deviation 22.2 |
| Real-time Group Video: Alzheimer's Patient | Cognitive Function | 18 Month Cognitive Function | 24.8 score on a scale | Standard Deviation 21.9 |
| Real-time Group Video: Caregiver | Cognitive Function | 18 Month Cognitive Function | 32.2 score on a scale | Standard Deviation 19.2 |
| Real-time Group Video: Caregiver | Cognitive Function | Baseline Cognitive Function | 41.9 score on a scale | Standard Deviation 10.1 |
| Real-time Group Video: Caregiver | Cognitive Function | 12 Month Cognitive Function | 34.9 score on a scale | Standard Deviation 18.5 |
| Real-time Group Video: Caregiver | Cognitive Function | 6 Month Cognitive Function | 34.7 score on a scale | Standard Deviation 16.8 |
Secondary
Functional Fitness
Functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching.
Time frame: Baseline to 18 months
Population: Number Analyzed differs from baseline at subsequent timepoints due to participant drops and missed data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Functional Fitness | Baseline Step Test | 66.8 Repetitions | Standard Deviation 28.4 |
| Real-time Group Video: Alzheimer's Patient | Functional Fitness | 6 Month Step Test | 76.9 Repetitions | Standard Deviation 28.3 |
| Real-time Group Video: Alzheimer's Patient | Functional Fitness | 12 Month Step Test | 74.9 Repetitions | Standard Deviation 28.9 |
| Real-time Group Video: Alzheimer's Patient | Functional Fitness | 18 Month Step Test | 73.3 Repetitions | Standard Deviation 25.6 |
| Real-time Group Video: Caregiver | Functional Fitness | 18 Month Step Test | 73.3 Repetitions | Standard Deviation 17.5 |
| Real-time Group Video: Caregiver | Functional Fitness | Baseline Step Test | 59.4 Repetitions | Standard Deviation 21.9 |
| Real-time Group Video: Caregiver | Functional Fitness | 12 Month Step Test | 66.7 Repetitions | Standard Deviation 19.5 |
| Real-time Group Video: Caregiver | Functional Fitness | 6 Month Step Test | 62.2 Repetitions | Standard Deviation 20.3 |
Secondary
Residential Transitions
Residential transitions, i.e., from home to institutional care, will be tracked by health coaches. Caregiver desire to institutionalize the adult with AD will be assessed using the 6-item Morycz's Desire-to-Institutionalize Scale
Time frame: Baseline to 18 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Residential Transitions | 6 Month Transitions | 0 Participants |
| Real-time Group Video: Alzheimer's Patient | Residential Transitions | 12 Month Transitions | 2 Participants |
| Real-time Group Video: Alzheimer's Patient | Residential Transitions | 18 Month Transitions | 5 Participants |
| Real-time Group Video: Caregiver | Residential Transitions | 12 Month Transitions | 3 Participants |
| Real-time Group Video: Caregiver | Residential Transitions | 6 Month Transitions | 0 Participants |
| Real-time Group Video: Caregiver | Residential Transitions | 18 Month Transitions | 3 Participants |
Secondary
Sedentary Time
Sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months.
Time frame: Baseline to 18 months
Population: Overall number of participants differs from Number analyzed below due to patients not meeting wear-time criteria for valid data. Only those with valid wear-time were included in analysis. Additionally, participant withdrawal resulted in differing numbers. This measure is for sedentary time of patients, only. Caregiver sedentary time can be found in secondary outcome 8.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Sedentary Time | Month 3 Sedentary Time | 532.1 minutes per day | Standard Deviation 150.6 |
| Real-time Group Video: Alzheimer's Patient | Sedentary Time | Month 12 Sedentary Time | 554.8 minutes per day | Standard Deviation 122.1 |
| Real-time Group Video: Alzheimer's Patient | Sedentary Time | Month 6 Sedentary Time | 552.5 minutes per day | Standard Deviation 129.5 |
| Real-time Group Video: Alzheimer's Patient | Sedentary Time | Month 18 Sedentary Time | 546.8 minutes per day | Standard Deviation 108.6 |
| Real-time Group Video: Alzheimer's Patient | Sedentary Time | Baseline Sedentary Time | 524.8 minutes per day | Standard Deviation 143.3 |
| Real-time Group Video: Caregiver | Sedentary Time | Month 18 Sedentary Time | 521.9 minutes per day | Standard Deviation 109.6 |
| Real-time Group Video: Caregiver | Sedentary Time | Baseline Sedentary Time | 590.1 minutes per day | Standard Deviation 158.7 |
| Real-time Group Video: Caregiver | Sedentary Time | Month 3 Sedentary Time | 577.2 minutes per day | Standard Deviation 175.6 |
| Real-time Group Video: Caregiver | Sedentary Time | Month 6 Sedentary Time | 601.4 minutes per day | Standard Deviation 137 |
| Real-time Group Video: Caregiver | Sedentary Time | Month 12 Sedentary Time | 647.3 minutes per day | Standard Deviation 355.1 |
Other Pre-specified
Body Mass Index
Weight will be measured in duplicate at baseline, 6, 12 and 18 months in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg. Standing height will be measured at baseline, 6, 12 and 18 months in duplicate with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK). BMI will be calculated as weight (kg)/height (m2).
Time frame: Baseline to 18 months
Population: Number analyzed below differs from overall number due to participant drops and missed data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Body Mass Index | 6 Month Body Mass Index | 26.5 kg/m2 | Standard Deviation 4.4 |
| Real-time Group Video: Alzheimer's Patient | Body Mass Index | Baseline Body Mass Index | 26.8 kg/m2 | Standard Deviation 4.6 |
| Real-time Group Video: Alzheimer's Patient | Body Mass Index | 12 Month Body Mass Index | 26.7 kg/m2 | Standard Deviation 4.6 |
| Real-time Group Video: Alzheimer's Patient | Body Mass Index | 18 Month Body Mass Index | 26.0 kg/m2 | Standard Deviation 3.6 |
| Real-time Group Video: Caregiver | Body Mass Index | 18 Month Body Mass Index | 28.8 kg/m2 | Standard Deviation 7.1 |
| Real-time Group Video: Caregiver | Body Mass Index | Baseline Body Mass Index | 28.4 kg/m2 | Standard Deviation 6.4 |
| Real-time Group Video: Caregiver | Body Mass Index | 6 Month Body Mass Index | 29.0 kg/m2 | Standard Deviation 6.7 |
| Real-time Group Video: Caregiver | Body Mass Index | 12 Month Body Mass Index | 29.1 kg/m2 | Standard Deviation 6.6 |
| Enhanced Usual Care: Alzheimer's Patient | Body Mass Index | 6 Month Body Mass Index | 26.7 kg/m2 | Standard Deviation 5.1 |
| Enhanced Usual Care: Alzheimer's Patient | Body Mass Index | 18 Month Body Mass Index | 27.1 kg/m2 | Standard Deviation 5 |
| Enhanced Usual Care: Alzheimer's Patient | Body Mass Index | Baseline Body Mass Index | 26.9 kg/m2 | Standard Deviation 5.3 |
| Enhanced Usual Care: Alzheimer's Patient | Body Mass Index | 12 Month Body Mass Index | 26.3 kg/m2 | Standard Deviation 4.9 |
| Enhanced Usual Care: Caregiver | Body Mass Index | 18 Month Body Mass Index | 28.8 kg/m2 | Standard Deviation 7.1 |
| Enhanced Usual Care: Caregiver | Body Mass Index | 6 Month Body Mass Index | 29.7 kg/m2 | Standard Deviation 6.3 |
| Enhanced Usual Care: Caregiver | Body Mass Index | 12 Month Body Mass Index | 29.3 kg/m2 | Standard Deviation 6.3 |
| Enhanced Usual Care: Caregiver | Body Mass Index | Baseline Body Mass Index | 29.5 kg/m2 | Standard Deviation 6 |
Other Pre-specified
Caregiver Support
Caregiver support will be assessed using the percentage of group exercise sessions (RGV) and/ or individual support sessions completed by both the person with AD and their caregiver.
Time frame: Baseline to 18 months
Post Hoc
Energy Expenditure of the Remote Sessions
Energy expenditure of the remote sessions will be assessed using a portable metabolic system.
Time frame: Baseline to 12 months
Other Pre-specified
Peer Interactions (RGV Only)
Staff will review video recordings of a random sample of 33% of group exercise sessions to identify and classify both peer to peer, and health coach to participant interactions. Interactions will be quantified and coded as verbal/non-verbal (waving, pointing, shaking head in agreement/disagreement), and as positive, neutral or negative, relative to support.
Time frame: Baseline to 18 months
Other Pre-specified
Quality of the Dyadic Relationship
Quality of the dyadic relationship will be assessed at baseline, 6, 12, and 18 mos. using the dyadic relationship scale (DRS) which measures negative and positive dyadic interactions from the perspective of both the patient and the caregiver. Scores range from 1-6, with higher scores indicating more positive dyadic relationships.
Time frame: Baseline to 18 months
Population: Number analyzed below differs from overall number due to participant drops and non-returned data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Quality of the Dyadic Relationship | 12 Month Quality of the dyadic relationship | 2.72 score on a scale | Standard Deviation 0.7 |
| Real-time Group Video: Alzheimer's Patient | Quality of the Dyadic Relationship | 6 Month Quality of the dyadic relationship | 2.71 score on a scale | Standard Deviation 0.71 |
| Real-time Group Video: Alzheimer's Patient | Quality of the Dyadic Relationship | 18 Month Quality of the dyadic relationship | 2.72 score on a scale | Standard Deviation 0.65 |
| Real-time Group Video: Alzheimer's Patient | Quality of the Dyadic Relationship | Baseline Quality of the dyadic relationship | 2.69 score on a scale | Standard Deviation 0.78 |
| Real-time Group Video: Caregiver | Quality of the Dyadic Relationship | 18 Month Quality of the dyadic relationship | 2.72 score on a scale | Standard Deviation 0.75 |
| Real-time Group Video: Caregiver | Quality of the Dyadic Relationship | 6 Month Quality of the dyadic relationship | 2.90 score on a scale | Standard Deviation 0.55 |
| Real-time Group Video: Caregiver | Quality of the Dyadic Relationship | 12 Month Quality of the dyadic relationship | 2.83 score on a scale | Standard Deviation 0.65 |
| Real-time Group Video: Caregiver | Quality of the Dyadic Relationship | Baseline Quality of the dyadic relationship | 2.92 score on a scale | Standard Deviation 0.66 |
Other Pre-specified
Self-monitoring of Physical Activity
Self-monitoring of physical activity will be assessed as the percentage of days with Fitbit data over a minimum of 8 hrs., between 6 am and midnight
Time frame: Baseline to 18 months
Other Pre-specified
Session Attendance
Session attendance for group exercise (RGV only) and support sessions will be obtained from records maintained by the health coach, and expressed as the percent of possible sessions from 0-6 mos. and 7-12 mos. Attendance for adults with AD, enrolled caregivers, and alternative caregivers will be recorded separately.
Time frame: Baseline to 18 months
Population: Number analyzed below differs from overall number due to participant drops. Measure only collected in Real-time Group Video arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Session Attendance | Baseline to 6 Months | 74.0 percent of possible sessions | Standard Deviation 31.3 |
| Real-time Group Video: Alzheimer's Patient | Session Attendance | Month 7 to Month 12 | 75.7 percent of possible sessions | Standard Deviation 46 |
| Real-time Group Video: Caregiver | Session Attendance | Baseline to 6 Months | 69.5 percent of possible sessions | Standard Deviation 33 |
| Real-time Group Video: Caregiver | Session Attendance | Month 7 to Month 12 | 71.0 percent of possible sessions | Standard Deviation 48 |
Other Pre-specified
Use of Recorded Videos
Use of recorded videos including frequency and duration of access (RGV only) will be assessed using Dropbox® analytics.
Time frame: Baseline to 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real-time Group Video: Alzheimer's Patient | Use of Recorded Videos | 0.17 Video views per week | Standard Deviation 0.7 |
| Real-time Group Video: Caregiver | Use of Recorded Videos | 0.17 Video views per week | Standard Deviation 0.7 |