Alzheimer Disease, Dementia
Conditions
Keywords
Dementia, Alzheimer Disease, Social Interaction, Quality of Life
Brief summary
The researchers propose to develop an informatics system to assist people with memory impairment. Persons with Memory Concern (PWMC) recognize the faces they see daily, such as a spouse or caregiver, but they may confuse visiting friends and grandchildren or they may not match names with faces well. The inability to remember names or relationships contributes to isolation and deeply affects their social lives. The proposed solution is a Smartwatch Reminder (SR) system to conspicuously provide this information to the PWMC when needed. The system will be evaluated on the target persons with memory concern population to measure engagement and improvements in social interactions and quality of life.
Detailed description
This research will evaluate technology designed to improve the quality of life for persons with dementia through external aids to assist with remembering. The primary goal of the Smartwatch Reminder (SR) is to facilitate social interaction for Persons with Memory Concern (PWMC) by providing facial recognition of family, friends, and other key people. The SR will be evaluated using an embedded experimental mixed methods design that combines the collection and analysis of qualitative data within a traditional randomized controlled trial design. To do so, researchers will enroll 100 PWMC and their care partners to participate in initial, 3-month, and 6-month surveys. Half of the PWMCs will be randomly assigned to the intervention group (i.e. receive the SR) and the other half randomly assigned to the attention control group. Each participant will take part in the study for a total of 6 months. All study procedures and data analysis are anticipated to be completed within 24 months.
Interventions
DEVICESmartwatch Reminder (SR) system
The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
Sponsors
Advanced Medical Electronics
University of Michigan
Brown University
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Researchers will enroll 100 PWMC and their care partners to participate in initial, 3-month, and 6-month surveys. Half of the PWMCs will be randomly assigned to the intervention group (to receive the SR) and the other half randomly assigned to the attention control group.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for PWMC are as follows: * English speaking * a physician diagnosis of early-stage Alzheimer's disease or mild-to-moderate cognitive impairment * no history of serious mental illness (i.e., any major psychiatric disorder) Inclusion criteria for care partners of PWMC are as follows: * English speaking * 21 years of age or over * self-identifies as someone who provides assistance to the PWMC because of their memory loss (these individuals are called ''care partners,'' as these individuals may or may not provide the intensive hands-on care typical of ''caregivers'') * plans to remain in the area for at least 6 months in order to reduce loss to follow-up * indicates a willingness to use the smartwatch system
Exclusion criteria
for PWMC are as follows: * non-English speaking * no physician diagnosis of early-stage Alzheimer's disease or mild-to-moderate cognitive impairment * a history of serious mental illness (i.e., any major psychiatric disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PWMC Loneliness | 3 months | Original three-item measure, including: * How often do you feel you lack companionship? * How often do you feel left out? * How often do you feel isolated from others? Scale range 3-9, higher scores indicate higher rates of social isolation. |
| PWMC Social Relationships and Social Support | 3 months | The Lubben Social Network Scale (LSNS) is a measure of social relationships and social support networks. We used the shortened 6-item scale to reduce test burden. The 6-item scale has a range of 0 - 30 with higher scores indicating more robust social networks / access to support. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PWMC Physical and Mental Well-being | 3 months | We used the Global Health Scale. This tool is designed to assess an individual's overall physical and mental wellbeing. The scale measures subjective health perceptions. Scale scores range from 0 - 100, with higher scores indicating higher rates of mental and physical well-being. |
Countries
United States
Participant flow
Pre-assignment details
81 caregivers consented and 81 persons with memory concerns consented or assented to be part of the study, totaling 162 participants or 81 dyads. Six participants or 3 dyads withdrew before randomization. Data is reported for the 156 randomized participants.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline, 3 months and 6 months following enrollment.
Smartwatch Reminder (SR) system: The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit. | 84 |
| Attention Control Group Care partners are administered surveys at baseline, 3 months and 6 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months and 6-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time. | 72 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participant wished to discontinue intervention use, but remained in study to complete surveys only. | 28 | 0 |
| Overall Study | Withdrawal by Subject | 12 | 8 |
Baseline characteristics
| Characteristic | Attention Control Group | Total | Intervention Group |
|---|---|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 10.7 | 69.9 years STANDARD_DEVIATION 12.1 | 70 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 146 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 64 Participants | 134 Participants | 70 Participants |
| Sex: Female, Male Female | 46 Participants | 98 Participants | 52 Participants |
| Sex: Female, Male Male | 26 Participants | 58 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 72 |
| other Total, other adverse events | 5 / 84 | 5 / 72 |
| serious Total, serious adverse events | 1 / 84 | 2 / 72 |
Outcome results
Primary
PWMC Loneliness
Original three-item measure, including: * How often do you feel you lack companionship? * How often do you feel left out? * How often do you feel isolated from others? Scale range 3-9, higher scores indicate higher rates of social isolation.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | PWMC Loneliness | 4.90 units on a scale |
| Attention Control Group | PWMC Loneliness | 5.28 units on a scale |
Primary
PWMC Social Relationships and Social Support
The Lubben Social Network Scale (LSNS) is a measure of social relationships and social support networks. We used the shortened 6-item scale to reduce test burden. The 6-item scale has a range of 0 - 30 with higher scores indicating more robust social networks / access to support.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | PWMC Social Relationships and Social Support | 13.50 units on a scale |
| Attention Control Group | PWMC Social Relationships and Social Support | 10.72 units on a scale |
Secondary
PWMC Physical and Mental Well-being
We used the Global Health Scale. This tool is designed to assess an individual's overall physical and mental wellbeing. The scale measures subjective health perceptions. Scale scores range from 0 - 100, with higher scores indicating higher rates of mental and physical well-being.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | PWMC Physical and Mental Well-being | 32.69 score on a scale |
| Attention Control Group | PWMC Physical and Mental Well-being | 32.72 score on a scale |