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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG058586 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
| National Institute on Aging (NIA) | NIH |
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This project adapts a novel activity-based companion care model, the Making Engagement Meaningful through Organized Routine Interaction (MEMORI) Corps intervention, for a virtual delivery format, and then implements the intervention in a pilot, two-arm, randomized controlled trial to evaluate intervention acceptability, feasibility, and preliminary efficacy versus an augmented waitlist control. MEMORI Corps is a companion care model that provides regular companionship and personalized activities to community-living persons with dementia (PWD) delivered by trained volunteer Companion Guides 55 years of age or older. Program goals are to reduce social isolation and improve health and well-being for PWD, reduce burden and provide support to family CGs, as well as provide health benefits and opportunities for meaningful engagement for older volunteer Companion Guides.
This project adapts a novel activity-based companion care model (MEMORI Corps) for community-living persons with dementia for a virtual delivery format, and then implements the intervention in a pilot, two-arm, randomized controlled trial to evaluate intervention acceptability, feasibility, and preliminary efficacy versus an augmented waitlist control. The goals of the program are to reduce social isolation and improve health and well-being for PWD, reduce burden and support family CGs, and to provide health benefits and meaningful engagement for older volunteer Companion Guides.
The target group is 60 dyads (persons living with dementia and their informal co-residing caregiver) and 36 companion guides (health volunteer 55 years of age and older). Participants are randomized 1:1 either to the intervention or waitlist control group. Waitlist participants are offered the opportunity for cross-over into active intervention group. PWD/CG outcomes will be assessed at Baseline, 6-, and 12-weeks (PWD/CG participation lasts 12 weeks). Volunteer Companion Guide outcomes will be assessed at baseline, 6-, and 12-months.
This model program could serve as an important new advancement for community-based long term care for PWD that addresses unmet patient- and family-centered needs through civic engagement of seniors. It could also serve as an intervention for dementia risk-reduction and brain health if found to be efficacious.
Specific aims are to:
Aim 1: Adapt and refine the MEMORI Corps intervention for a virtual delivery format using iterative user-centered design principles and multiple stakeholder input.
Aim 2: Conduct a pilot, two-arm, randomized controlled trial to evaluate acceptability, feasibility, safety, and preliminary efficacy of the MEMORI Corps intervention (vs. wait list control group) in 60 community-living person's living with demential (PLWD) and informal caregiver dyads and 36 volunteer companion guides from geographically and demographically diverse regions in Maryland.
Aim 3: Evaluate the feasibility of ascertainment of community-living PLWD, caregiver, and volunteer-level outcomes over time using virtual and telephonic data collection methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Intervention | Experimental | Intervention arm with MEMORI Corps program |
|
| Control | Other | Augmented waitlist control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEMORI Corps program | Behavioral | MEMORI Corps program: Virtual activity-based companion care program. Delivered by trained volunteers 55 years and older, supported by a clinical team, over a 12-week intervention period (up to 5 hours per week, one or more days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide socialization, companionship, and a personalized activity program that focuses on meaningful, engaging and enjoyable activities that match the participant's abilities and interests. Delivered virtually by Zoom. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score | The total score (frequency x severity) of the Neuropsychiatric Inventory (NPI) scale will be used to measure neuropsychiatric and behavioral symptoms. The NPI is a proxy rating of person with dementia's severity, frequency, and distress across 12 types of neuropsychiatric behavior problems. Scores can range from 0-144, with higher score indicating greater neuropsychiatric behavioral burden. | Baseline - 12 weeks |
| Change in Quality of Life as Assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) Tool | The total score (sum of all items) for the Quality of life in Alzheimer's Disease (QOL-AD) tool will assess quality of life in the context of Alzheimer's Disease. The QOL-AD has a self-rated and proxy-rated version for persons with dementia, and was specifically developed for use in dementia. Scores can range from 13-52, with higher scores indicating better quality of life. | Baseline - 12 weeks |
| Change in Subjective Caregiver Burden as Assessed by the Zarit Burden Inventory-Short Form | The total score (sum of items) for the Zarit Burden Inventory-Short Form-12 items (ZBI) will assess subjective caregiver burden. The ZBI short form is a self-rated 12-item measure of caregiver subjective burden rating related to caregiving for persons with dementia. Scores can range from 0-48, with higher scores indicating greater perceived burden. | Baseline - 12 weeks |
| Change in Depressive Symptoms in Caregivers as Assessed by The Patient Health Questionnaire (PHQ) - 8 | The total score (sum of items) for the The Patient Health Questionnaire (PHQ) - 8 will assess depressive symptoms severity. The PHQ-8 is a self-rated 8 item measure of caregiver depressive symptoms. Scores can range from 0-24, with higher scores indicating greater depressive symptoms. | Baseline - 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver Time Spent Helping Person Living With Dementia | Two individual items ask caregivers to estimate hours per day spent doing caregiving activities, and hours per day spent with the person with dementia in a typical week. Objective measure of caregiver burden. Higher time estimates in performing these tasks indicate greater objective burden. | Baseline - 12 weeks |
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Inclusion Criteria:
Persons with dementia and informal caregiver (PWD/CG) must both meet eligibility criteria. These criteria are designed to reduce PWD/CG attrition and ensure safety of PWD, CG, and volunteers.
PWD are eligible if:
CG are eligible if:
Volunteers (i.e. "Companion Guides") are eligible if:
Exclusion Criteria:
PWD are excluded if:
CGs are excluded if:
Volunteers are excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Quincy Samus, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
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Completed enrollment of 175 individual participants. 173 were randomized (61 Persons Living With Dementia (PLWD), 61 Family Caregivers, 51 Volunteer/Companion Guides). 1 dyad was inadvertently not randomized after baseline and excluded from analysis.
Overall, we received over 650 community-based referrals from over 20 unique community-based referral sources (including health care and non-health care related sources).
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Intervention | Intervention arm with MEMORI Corps program MEMORI Corps program: Virtual activity-based companion care program. Delivered by trained senior volunteers, supported by a clinical team, over a 12-week intervention period (up to 5 hours per week, one or more days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide socialization, companionship, and a personalized activity program that focuses on meaningful, engaging and enjoyable activities that match the participant's abilities and interests. |
| FG001 | Control | Augmented waitlist control. Augmented Waitlist Control: Persons with dementia/caregivers will continue any services and supports being used, will receive a free copy of "A Caregiver's Guide to Dementia: Using Activities and Other Strategies to Prevent, Reduce and Manage Behavioral Symptom"103), a Resource Guide with written educational materials on local, regional and national resources, management of CG stress/well-being, and check-in calls to answer any questions about the materials. Volunteers randomized to waitlist control will continue with usual activities (volunteer or other), and will receive additional written educational materials on cognitive health (NIA) and exercise and Physical Activity (Go4Life), referrals to the Baltimore City Commission on Aging and Retirement Education for volunteering opportunities, and check-in calls to answer questions and maintain engagement. Waitlist dyads will be followed at specified intervals by the research team and then offered an opportunity for participation in the intervention arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Intervention | Intervention arm with MEMORI Corps program MEMORI Corps program: MEMORI Corps program: Virtual activity-based companion care program. Delivered by trained volunteers 55 years and older, supported by a clinical team, over a 12-week intervention period (up to 5 hours per week, one or more days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide socialization, companionship, and a personalized activity program that focuses on meaningful, engaging and enjoyable activities that match the participant's abilities and interests. Delivered virtually by Zoom. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The total participant sample is comprised of 3 subgroups of participants (Persons living with Dementia, Caregivers, and Volunteer Companion Guides) and these have been represented separately in rows. |
| 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 | Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score | The total score (frequency x severity) of the Neuropsychiatric Inventory (NPI) scale will be used to measure neuropsychiatric and behavioral symptoms. The NPI is a proxy rating of person with dementia's severity, frequency, and distress across 12 types of neuropsychiatric behavior problems. Scores can range from 0-144, with higher score indicating greater neuropsychiatric behavioral burden. | Person with dementia participant outcome, intent to treat | Posted | Mean | Standard Deviation | score on a scale | Baseline - 12 weeks |
|
Up to 24 weeks for persons living with dementia. Up to 24 months for healthy volunteer companion guide participants.
Adverse event data was not collected for family 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 | Active Intervention-PLWD | Intervention arm with MEMORI Corps program MEMORI Corps program: Virtual activity-based companion care program. Delivered by trained senior volunteers, supported by a clinical team, over a 12-week intervention period (up to 5 hours per week, one or more days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide socialization, companionship, and a personalized activity program that focuses on meaningful, engaging and enjoyable activities that match the participant's abilities and interests. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Quincy Samus, Professor | Johns Hopkins University | 4105506493 | qmiles@jhmi.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 | Oct 11, 2023 | Nov 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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Activity-based companion care program. MEMORI Corps is a companion care model that provides regular companionship and personalized activities to community-living persons with dementia (PWD) delivered by trained volunteer Companion Guides 55 years of age or older. Core intervention components include: (1) detailed virtual assessment of health, well-being, and interests of PWD; (2) personalized activity plans; (3) specialized training of volunteer Companion Guides in virtual program delivery; (4) regular companionship and personalized activities delivered to PWD over 12 weeks; (5) family caregiver education on activity plans and ways to utilize respite opportunities; and (6) multidisciplinary expert support of volunteer companion guides. The goals of the program are to reduce social isolation and improve health and well-being for PWD, reduce burden and support family CGs, and to provide health benefits and meaningful engagement for older volunteer Companion Guides.
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Single blind, pilot, randomized controlled trial where outcome assessors are masked to treatment arm allocation.
|
| Augmented Waitlist Control | Other | Participants living with dementia/caregivers will continue any services and supports already engaged with, will receive a free copy of "A Caregiver's Guide to Dementia: Using Activities and Other Strategies to Prevent, Reduce and Manage Behavioral Symptom"), a Resource Guide (ie.,local, regional and national resources), and check-in calls to answer any questions about the materials. Waitlist are offered full intervention after waitlist period. Volunteers randomized to waitlist control continue usual activities (volunteer or other), and resource a resource guide on cognitive health (NIA) and exercise and Physical Activity (Go4Life), referrals to volunteering opportunities, and check-in calls to answer questions and maintain engagement. Waitlist dyads will be followed at specified intervals by the research team and then offered an opportunity for participation in the intervention arm. |
|
| Change in Perceived Loneliness as Measured by UCLA 3 Loneliness Scale |
Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness. |
| Baseline - 12 weeks |
| Change in Perceived Loneliness for Caregiver as Measured by UCLA 3 Loneliness Scale | Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness. | Baseline - 12 weeks |
| Program Satisfaction and Perceived Impact Survey | 55 item likert scale survey assessing program delivery, feasibility, acceptability, perceived program impact. Total score range from 55-253 with higher scores indicating greater satisfaction and perceived feasibility, with higher scores indicating | 12-weeks post intervention |
| Change in Perceived Impact of Leisure Activities as Measured by Leisure Activity Participation Impact Scale | 11 item scale measuring the subjective impact of leisure activity participation on several areas of life and emotional well-being. Scores range from 11-55 with higher scores indicating more beneficial subjective impact of leisure activities | Baseline - 12 weeks |
| Change in Depressive Symptoms in Senior Companion Volunteers as Assessed by The Patient Health Questionnaire (PHQ) - 8 | The total score (sum of items) for the The Patient Health Questionnaire (PHQ) - 8 will assess depressive symptoms severity in senior companion volunteers. The PHQ-8 is a self-rated 8 item measure of caregiver depressive symptoms. Scores can range from 0-24, with higher scores indicating greater depressive symptoms. | Baseline -12 weeks |
| BG001 | Control | Augmented waitlist control. Augmented Waitlist Control: Participants living with dementia/caregivers will continue any services and supports thy are already engaged with, will receive a free copy of "A Caregiver's Guide to Dementia: Using Activities and Other Strategies to Prevent, Reduce and Manage Behavioral Symptom"), a Resource Guide (ie.,local, regional and national resources), and check-in calls to answer any questions about the materials. Waitlist are offered full intervention after waitlist period. Volunteers randomized to waitlist control continue their usual activities (volunteer or other), and resource a resource guide on cognitive health (NIA) and exercise and Physical Activity (Go4Life), referrals to volunteering opportunities, and check-in calls to answer questions and maintain engagement. Waitlist dyads will be followed at specified intervals by the research team and then offered an opportunity for participation in the intervention arm. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | The total participant sample is comprised of 3 subgroups of participants (Persons living with Dementia, Caregivers, and Volunteer Companion Guides) and these have been represented separately in rows. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | The total participant sample is comprised of 3 subgroups of participants (Persons living with Dementia, Caregivers, and Volunteer Companion Guides) and these have been represented separately in rows. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The total participant sample is comprised of 3 subgroups of participants (Persons living with Dementia, Caregivers, and Volunteer Companion Guides) and these have been represented separately in rows. | Count of Participants | Participants |
|
| Neuropsychiatric Inventory (NPI) Score | Person with dementia measure. The total score (frequency x severity) of the Neuropsychiatric Inventory (NPI) scale will be used to measure neuropsychiatric and behavioral symptoms. The NPI is a proxy rating of person with dementia's severity, frequency, and distress across 12 types of neuropsychiatric behavior problems. Scores can range from 0-144, with higher score indicating greater neuropsychiatric behavioral burden. | This baseline measure is for a subset of participants (i.e., persons living with dementia, PWD). Excludes caregiver and senior volunteer companion guide participants. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life in Alzheimer's Disease (QOL-AD) | The total score (sum of all items) for the Quality of life in Alzheimer's Disease (QOL-AD) tool will assess quality of life in the context of Alzheimer's Disease. The QOL-AD has a self-rated and proxy-rated version for persons with dementia, and was specifically developed for use in dementia. Scores can range from 13-52, with higher scores indicating better quality of life. | This baseline measure is for a subset of participants (i.e., persons living with dementia, PWD). Excludes caregiver and senior volunteer companion guide participants. | Mean | Standard Deviation | units on a scale |
|
| Zarit Burden Inventory-Short Form | The total score (sum of items) for the Zarit Burden Inventory-Short Form-12 items (ZBI) will assess subjective caregiver burden. The ZBI short form is a self-rated 12-item measure of caregiver subjective burden rating related to caregiving for persons with dementia. Scores can range from 0-48, with higher scores indicating greater perceived burden. | This baseline measure is for a subset of participants (i.e., Caregivers of persons living with dementia-CGs). Excludes persons living with dementia and senior volunteer companion guide participants. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire (PHQ) - 8 | The total score (sum of items) for the The Patient Health Questionnaire (PHQ) - 8 will assess depressive symptoms severity. The PHQ-8 is a self-rated 8 item measure of caregiver depressive symptoms. Scores can range from 0-24, with higher scores indicating greater depressive symptoms. | This baseline measure is for a subset of participants (i.e., persons living with dementia, PWD). Excludes caregiver and senior volunteer companion guide participants. | Mean | Standard Deviation | units on a scale |
|
| Leisure Activity Participation Impact Scale | 11 item scale measuring the subjective impact of leisure activity participation on several areas of life and emotional well-being. Scores range from 11-55 with higher scores indicating more beneficial subjective impact of leisure activities | This baseline measure is for a subset of participants (i.e., persons living with dementia, PWD). Excludes caregiver and senior volunteer companion guide participants. | Mean | Standard Deviation | units on a scale |
|
| UCLA 3 Loneliness Scale | Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness. | This baseline measure is for a subset of participants (i.e., persons living with dementia, PWD). Excludes caregiver and senior volunteer companion guide participants. | Mean | Standard Deviation | units on a scale |
|
| Caregiver UCLA 3 Loneliness Scale | Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness. | This baseline measure is for a subset of participants (i.e., caregivers of persons living with dementia). Excludes persons living with dementia and senior volunteer companion guide participants. | Mean | Standard Deviation | units on a scale |
|
| Caregiver Time Spent Helping PLWD in Last Week | This item ask caregivers to estimate hours spent in past week helping or doing activities for the person living with dementia. Higher values indicate greater number of hours spent helping or doing activities for with the person living with dementia. | This baseline measure is for a subset of participants (i.e., caregivers of PWD). Excludes person with dementia (PWD) and senior volunteer companion guide participants. | Mean | Standard Deviation | hours per week |
|
| Senior Companion Volunteers Patient Health Questionnaire ( | The total score (sum of items) for the The Patient Health Questionnaire (PHQ) - 8 will assess depressive symptoms severity in senior companion volunteers. The PHQ-8 is a self-rated 8 item measure of caregiver depressive symptoms. Scores can range from 0-24, with higher scores indicating greater depressive symptoms. | This baseline measure is for a subset of participants (i.e., senior volunteer companion guide participants). Excludes persons living with dementia and caregiver participants. | Mean | Standard Deviation | units on a scale |
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| OG001 | Control | Augmented waitlist control. Augmented Waitlist Control: Persons with dementia/caregivers will continue any services and supports being used, will receive a free copy of "A Caregiver's Guide to Dementia: Using Activities and Other Strategies to Prevent, Reduce and Manage Behavioral Symptom"103), a Resource Guide with written educational materials on local, regional and national resources, management of CG stress/well-being, and check-in calls to answer any questions about the materials. Volunteers randomized to waitlist control will continue with usual activities (volunteer or other), and will receive additional written educational materials on cognitive health (NIA) and exercise and Physical Activity (Go4Life), referrals to the Baltimore City Commission on Aging and Retirement Education for volunteering opportunities, and check-in calls to answer questions and maintain engagement. Waitlist dyads will be followed at specified intervals by the research team and then offered an opportunity for participation in the intervention arm. |
|
|
| Primary | Change in Quality of Life as Assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) Tool | The total score (sum of all items) for the Quality of life in Alzheimer's Disease (QOL-AD) tool will assess quality of life in the context of Alzheimer's Disease. The QOL-AD has a self-rated and proxy-rated version for persons with dementia, and was specifically developed for use in dementia. Scores can range from 13-52, with higher scores indicating better quality of life. | Person with dementia participant outcome, intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 12 weeks |
|
|
|
| Primary | Change in Subjective Caregiver Burden as Assessed by the Zarit Burden Inventory-Short Form | The total score (sum of items) for the Zarit Burden Inventory-Short Form-12 items (ZBI) will assess subjective caregiver burden. The ZBI short form is a self-rated 12-item measure of caregiver subjective burden rating related to caregiving for persons with dementia. Scores can range from 0-48, with higher scores indicating greater perceived burden. | Caregivers of persons with dementia participants, Intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 12 weeks |
|
|
|
| Primary | Change in Depressive Symptoms in Caregivers as Assessed by The Patient Health Questionnaire (PHQ) - 8 | The total score (sum of items) for the The Patient Health Questionnaire (PHQ) - 8 will assess depressive symptoms severity. The PHQ-8 is a self-rated 8 item measure of caregiver depressive symptoms. Scores can range from 0-24, with higher scores indicating greater depressive symptoms. | Caregiver of person living with dementia outcome, intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 12 weeks |
|
|
|
| Primary | Change in Perceived Loneliness as Measured by UCLA 3 Loneliness Scale | Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness. | Person living with dementia participant outcome, intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 12 weeks |
|
|
|
| Primary | Change in Perceived Loneliness for Caregiver as Measured by UCLA 3 Loneliness Scale | Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness. | Caregiver of person with dementia outcome, intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline - 12 weeks |
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| Primary | Program Satisfaction and Perceived Impact Survey | 55 item likert scale survey assessing program delivery, feasibility, acceptability, perceived program impact. Total score range from 55-253 with higher scores indicating greater satisfaction and perceived feasibility, with higher scores indicating | caregivers in intervention arm only of persons with dementia receiving intervention, intent to treat | Posted | Mean | Standard Deviation | score on a scale | 12-weeks post intervention |
|
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| Primary | Change in Perceived Impact of Leisure Activities as Measured by Leisure Activity Participation Impact Scale | 11 item scale measuring the subjective impact of leisure activity participation on several areas of life and emotional well-being. Scores range from 11-55 with higher scores indicating more beneficial subjective impact of leisure activities | Person living with dementia participant outcome, intent to treat | Posted | Mean | Standard Deviation | score on a scale | Baseline - 12 weeks |
|
|
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| Secondary | Change in Caregiver Time Spent Helping Person Living With Dementia | Two individual items ask caregivers to estimate hours per day spent doing caregiving activities, and hours per day spent with the person with dementia in a typical week. Objective measure of caregiver burden. Higher time estimates in performing these tasks indicate greater objective burden. | caregiver of person living with dementia participant outcomes, intent to treatment | Posted | Mean | Standard Deviation | hours per week | Baseline - 12 weeks |
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| Secondary | Change in Depressive Symptoms in Senior Companion Volunteers as Assessed by The Patient Health Questionnaire (PHQ) - 8 | The total score (sum of items) for the The Patient Health Questionnaire (PHQ) - 8 will assess depressive symptoms severity in senior companion volunteers. The PHQ-8 is a self-rated 8 item measure of caregiver depressive symptoms. Scores can range from 0-24, with higher scores indicating greater depressive symptoms. | Outcome is only for senior companion guide volunteer participants, intent to treat. This outcome is for a subset of participants (i.e., senior volunteer companion guides). Excludes PLWD and caregiver participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline -12 weeks |
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|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Active Intervention - Volunteer/Companion Guides | Intervention arm with MEMORI Corps program MEMORI Corps program: Virtual activity-based companion care program. Delivered by trained senior volunteers, supported by a clinical team, over a 12-week intervention period (up to 5 hours per week, one or more days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide socialization, companionship, and a personalized activity program that focuses on meaningful, engaging and enjoyable activities that match the participant's abilities and interests. | 1 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Waitlist Control - PLWD | tervention arm with MEMORI Corps program MEMORI Corps program: Virtual activity-based companion care program. Delivered by trained senior volunteers, supported by a clinical team, over a 12-week intervention period (up to 5 hours per week, one or more days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide socialization, companionship, and a personalized activity program that focuses on meaningful, engaging and enjoyable activities that match the participant's abilities and interests. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG003 | Waitlist Control - Volunteer/Companion Guides | tervention arm with MEMORI Corps program MEMORI Corps program: Virtual activity-based companion care program. Delivered by trained senior volunteers, supported by a clinical team, over a 12-week intervention period (up to 5 hours per week, one or more days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide socialization, companionship, and a personalized activity program that focuses on meaningful, engaging and enjoyable activities that match the participant's abilities and interests. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG004 | Waitlist Received Intervention - PLWD | Augmented waitlist control. Augmented Waitlist Control: Persons with dementia/caregivers will continue any services and supports being used, will receive a free copy of "A Caregiver's Guide to Dementia: Using Activities and Other Strategies to Prevent, Reduce and Manage Behavioral Symptom"103), a Resource Guide with written educational materials on local, regional and national resources, management of CG stress/well-being, and check-in calls to answer any questions about the materials. Volunteers randomized to waitlist control will continue with usual activities (volunteer or other), and will receive additional written educational materials on cognitive health (NIA) and exercise and Physical Activity (Go4Life), referrals to the Baltimore City Commission on Aging and Retirement Education for volunteering opportunities, and check-in calls to answer questions and maintain engagement. Waitlist dyads will be followed at specified intervals by the research team and then offered an opportunity for participation in the intervention arm. | 0 | 28 | 0 | 22 | 0 | 22 |
| EG005 | Waitlist Received Intervention - Volunteer/Companion Guides | tervention arm with MEMORI Corps program MEMORI Corps program: Virtual activity-based companion care program. Delivered by trained senior volunteers, supported by a clinical team, over a 12-week intervention period (up to 5 hours per week, one or more days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide socialization, companionship, and a personalized activity program that focuses on meaningful, engaging and enjoyable activities that match the participant's abilities and interests. | 0 | 27 | 0 | 5 | 0 | 5 |
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| Between 18 and 65 years |
|
| >=65 years |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|