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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG061187 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time Group Video | Other |
| |
| Enhanced Usual Care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time Group Video | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary Time | Sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months. | Baseline to 18 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 18 months |
Inclusion Criteria:
Adults with AD -
Caregivers-
Exclusion Criteria: Adults with AD-
Caregivers-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas | Lawrence | Kansas | 66045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | minutes per day | Baseline to 18 months |
|
Data collected over 18 month intervention.
Number of participants at Risk in all categories is combined to include both Alzheimer's Patients and Caregivers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hospitalization due to fracture or muscular pain |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bee sting | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Ptomey | University of Kansas Medical Center | 913-588-7983 | lptomey@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2022 | Mar 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Enhanced Usual Care | Behavioral | 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. |
|
| Baseline to 18 months |
| 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. | Baseline to 18 months |
| 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. | Baseline to 18 months |
| 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 | Baseline to 18 months |
| 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. | Baseline to 18 months |
| Caregiver Sedentary Time | Caregiver sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months. | Baseline to 18 months |
| 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. | Baseline to 18 months |
| 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. | Baseline to 18 months |
| 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. | Baseline to 18 months |
| 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. | Baseline to 18 months |
| Use of Recorded Videos | Use of recorded videos including frequency and duration of access (RGV only) will be assessed using Dropbox® analytics. | Baseline to 18 months |
| 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 | Baseline to 18 months |
| 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. | Baseline to 18 months |
| 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. | Baseline to 18 months |
| 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. | Baseline to 18 months |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Moved to longterm care facility |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| Secondary | Sedentary Time | Sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months. | 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. | Posted | Mean | Standard Deviation | minutes per day | Baseline to 18 months |
|
|
|
| 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. | Number Analyzed differs from baseline at subsequent timepoints due to participant drops and missed data collection. | Posted | Mean | Standard Deviation | Repetitions | Baseline to 18 months |
|
|
|
| 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. | Number Analyzed differs from overall analyzed due to participant drops and non-returned data. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 18 months |
|
|
|
| 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. | Number analyzed differs from overall participants due to participant drops and non-returned surveys. Measure only pertained to Alzheimer's Patient. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 18 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | Baseline to 18 months |
|
|
|
| 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. | Number analyzed below differs from overall due to participant drops and non-returned data. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 18 months |
|
|
|
| Secondary | Caregiver Sedentary Time | Caregiver sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months. | 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. | Posted | Mean | Standard Deviation | minutes per day | Baseline to 18 months |
|
|
|
| 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. | Number Analyzed differs from baseline at subsequent timepoints due to participant drops and missed data collection. | Posted | Mean | Standard Deviation | Reptetitions | Baseline to 18 months |
|
|
|
| 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. | Number analyzed below differs from overall number due to participant drops and non-returned data. Measure only collected from Caregivers. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 18 months |
|
|
|
| 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. | Number analyzed differs from overall due to participant drops and non-returned data. Measure was collected from Caregivers only. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 18 months |
|
|
|
| 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). | Number analyzed below differs from overall number due to participant drops and missed data collection. | Posted | Mean | Standard Deviation | kg/m2 | 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. | Number analyzed below differs from overall number due to participant drops. Measure only collected in Real-time Group Video arm. | Posted | Mean | Standard Deviation | percent of possible sessions | Baseline to 18 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Video views per week | Baseline to 18 months |
|
|
|
| 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 | Not Posted | Baseline to 18 months | Participants |
| 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. | Not Posted | Baseline to 18 months | Participants |
| 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. | Not Posted | Baseline to 18 months | Participants |
| 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. | Number analyzed below differs from overall number due to participant drops and non-returned data. | Posted | Mean | Standard Deviation | score on a scale | 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. | Not Posted | Baseline to 12 months | Participants |
| 3 |
| 57 |
| 9 |
| 57 |
| 28 |
| 57 |
| EG001 | 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. | 0 | 57 | 6 | 57 | 23 | 57 |
| EG002 | 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. | 0 | 42 | 7 | 42 | 21 | 42 |
| EG003 | 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. | 0 | 42 | 1 | 42 | 6 | 42 |
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| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory hospitalization |
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| Hospitalization | Nervous system disorders | Systematic Assessment |
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| Hospitalization | Infections and infestations | Systematic Assessment |
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| Hospitalization | Cardiac disorders | Systematic Assessment |
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| Hospitalization | Gastrointestinal disorders | Systematic Assessment |
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| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Low blood pressure | Cardiac disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Ankle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Graves Disease Diagnosis | Endocrine disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Eye surgery | Eye disorders | Systematic Assessment |
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| Skin Cancer removal | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Arm surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Outpatient |
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| Respite care | General disorders | Systematic Assessment |
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| Choking | Gastrointestinal disorders | Systematic Assessment |
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| Chronic Kidney Disease Flare Up | Renal and urinary disorders | Systematic Assessment |
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| Stepped on broken glass | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pelvic Prolapse Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Outpatient |
|
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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|
|
| Month 3 Sedentary Time |
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| Month 6 Sedentary Time |
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| Month 12 Sedentary Time |
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| Month 18 Sedentary Time |
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| 6 Month Step Test |
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| 12 Month Step Test |
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| 18 Month Step Test |
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| 6 Month Activities of Daily Living |
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| 12 Month Activities of Daily Living |
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| 18 Month Activities of Daily Living |
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| 6 Month Quality of Life |
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| 12 Month Quality of Life |
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| 18 Month Quality of Life |
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| 18 Month Transitions |
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| 6 Month Cognitive Function |
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| 12 Month Cognitive Function |
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| 18 Month Cognitive Function |
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| 6 Month Sedentary Time |
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| 12 Month Sedentary Time |
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| 18 Month Sedentary Time |
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| 6 Month Step Test |
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| 12 Month Step Test |
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| 18 Month Step Test |
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| 6 Month Caregiver Quality of Life |
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| 12 Month Caregiver Quality of Life |
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| 18 Month Caregiver Quality of Life |
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| 6 Month Caregiver Burden |
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| 12 Month Caregiver Burden |
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| 18 Month Caregiver Burden |
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| 6 Month Body Mass Index |
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| 12 Month Body Mass Index |
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| 18 Month Body Mass Index |
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| Month 7 to Month 12 |
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| 6 Month Quality of the dyadic relationship |
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| 12 Month Quality of the dyadic relationship |
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| 18 Month Quality of the dyadic relationship |
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