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| Name | Class |
|---|---|
| Advanced Medical Electronics | OTHER |
| University of Michigan | OTHER |
| Brown University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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 and 3 months following enrollment. |
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| Attention Control Group | No Intervention | Care partners are administered surveys at baseline and 3 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartwatch Reminder (SR) system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PWMC Loneliness | Original three-item measure, including:
| 3 months |
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion criteria for PWMC are as follows:
Inclusion criteria for care partners of PWMC are as follows:
Exclusion Criteria for PWMC are as follows:
Exclusion criteria for care partners of PWMC are as follows:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Public access to the research data generated from this project will be offered via de-identified data files maintained by the investigators. All personal identifiers of family caregivers of persons with Alzheimer's disease or a related dementia (ADRD) participating in the study will be removed and replaced with random identification numbers prior to distributing data files. Potential external investigators will be asked to complete a data use agreement and a recommended citation to these materials will be provided. Data from the project will be maintained on a secure University of Minnesota School of Public Health shared server for 3 years following study completion.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
While 162 individuals (81 dyads) initially enrolled in the study, only 156 individuals (78 dyads) completed the baseline survey and moved to randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | PWMC Loneliness | Original three-item measure, including:
| Posted | Mean | 90% Confidence Interval | units on a scale | 3 months |
|
Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Person with Memory Concerns Stroke | Cardiac disorders | Systematic Assessment | Caregiver shared the person with memory concerns experienced a stroke. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes hospitalization | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jude Mikal | University of Minnesota | 385-212-4185 | jpmikal@umn.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 | Sep 29, 2023 | Apr 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 29, 2023 | Apr 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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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.
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Attention Control Group | Care partners are administered surveys at baseline and 3 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-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. |
|
|
| 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. | Posted | Mean | 90% Confidence Interval | units on a scale | 3 months |
|
|
|
| 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. | Posted | Mean | 90% Confidence Interval | score on a scale | 3 months |
|
|
|
| 0 |
| 84 |
| 1 |
| 84 |
| 5 |
| 84 |
| EG001 | 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. | 0 | 72 | 2 | 72 | 5 | 72 |
|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment | Caregiver indicated that the person with memory concerns had been hospitalized for suicidal ideation due to medication side effects |
|
| PWMC Fractured Pelvis | Injury, poisoning and procedural complications | Systematic Assessment | Person with memory concerns fractured their pelvis. |
|
| Weather related fall | Injury, poisoning and procedural complications | Systematic Assessment | Caregiver fell on ice resulting in surgery. |
|
| Low blood pressure | Cardiac disorders | Systematic Assessment | Caregiver shared that a change in their regular activity was due to low blood pressure. |
|
| Eye Surgery | Eye disorders | Systematic Assessment | Caregiver shared that the person with memory concerns had eye surgery. |
|
| Knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment | Care giver had a planned knee replacement surgery. |
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| Back surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Caregiver had planned back surgery |
|
| PWMC Instability and memory concerns | Congenital, familial and genetic disorders | Systematic Assessment | CG shared that the PWMC was needing more outpatient doctor visits for instability and memory concerns. |
|
| Person with memory concerns flu | Infections and infestations | Systematic Assessment | Caregiver shared the PWMC had flu weeks earlier. |
|
| Sepsis | Blood and lymphatic system disorders | Systematic Assessment | Caregiver hospitalized for sepsis due to kidney infection. |
|
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |