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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG042191-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to learn more about how to maintain health and independence for seniors by developing tools that collect data constantly from their home. Caregivers can then use this information to make decisions about their health care, such as when an individual may not be able to live independently any longer. Specific Aims of this study are:
The proposed study has the potential to transform current research and clinical practice paradigms of prediction and decision making about independent living. This is accomplished by shifting from reliance on episodic, self-reported or crisis event provoked data to the use of ecologically valid multidimensional and continuous physiological, activity, and behavioral data. This approach has great potential to substantially improve care need and transition decisions. In achieving this goal several innovations beyond available systems and ongoing research are notable. First, grounded by prior studies associating static clinical measures to future placement outcomes, we now contemporaneously and continuously will acquire fundamental physiological measures (weight and walking speed), activity and behavioral measures, thereby improving our ability to proactively discriminate important health and functional change in real time. Using existing in-home activity data collected longitudinally in an aging population combined with simulated data from additional new sensed measures (phone use, medication taking, body composition) we will generate derived novel metrics - AIMs - to provide objective dynamic measures of activity and behaviors that are essential to maintaining independence. These metrics will be used to develop prediction algorithms based on documented transition outcomes from the original data set to be used by care teams (Aim 1). Working care transition professionals will be iteratively queried for the refinement of these objective measures (Aim 2). These care providers' expertise and understanding of key changes that impact independence is invaluable to identification of ambient independence measures that matter, and lead to meaningful care implementation pathways. The efficacy of the final set of measures chosen and built into a user friendly interface for the care team to use (Aim 2) will then be tested (Aim 3) by comparing independently living seniors in one of three comparison groups: 1) installed technology, from which AIMs data will be extracted and provided to the care transition team to aid in transition decisions; 2) installed technology, from which AIMs data will be extracted but will not be available to the transition team; and 3) no technology. We may have insufficient power to recognize significant change between the validation group and the control group. However, this primarily study is intended to test the feasibility of the approach, and to identify those types of AIMs data that are most useful for making transition decisions, which will be used to inform larger, more definitive studies in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared Data | Experimental | Share activity data with care team. Participants will have sensor technology installed in their home and caregivers will be provided with the data via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors. |
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| Non-shared Data | No Intervention | Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Share activity data with care team | Other | Share participant in-home activity data with retirement community care team. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Increased Need for Assistance During 3-year Study Period | Self-reported endorsement to the question "In the past week, is someone newly assisting you with medication management, bathing, dressing or grooming?" OR permanent move from independent living to assisted living or to a health care center | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kaye, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30102277 | Background | Kaye J, Reynolds C, Bowman M, Sharma N, Riley T, Golonka O, Lee J, Quinn C, Beattie Z, Austin J, Seelye A, Wild K, Mattek N. Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data. J Vis Exp. 2018 Jul 27;(137):56942. doi: 10.3791/56942. | |
| 29107052 | Background | Seelye A, Mattek N, Sharma N, Riley T, Austin J, Wild K, Dodge HH, Lore E, Kaye J. Weekly observations of online survey metadata obtained through home computer use allow for detection of changes in everyday cognition before transition to mild cognitive impairment. Alzheimers Dement. 2018 Feb;14(2):187-194. doi: 10.1016/j.jalz.2017.07.756. Epub 2017 Oct 26. |
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Ninety-six participants were enrolled and signed consent however five withdrew before randomization and data collection began.
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| ID | Title | Description |
|---|---|---|
| FG000 | Shared Data | Share activity data with care team. Participants will have sensor technology installed in their home and caregivers will be provided with the data via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors. Share activity data with care team: Share participant in-home activity data with retirement community care team. |
| FG001 | Non-shared Data | Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Ninety-six participants were assessed for eligibility and 91 were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Shared Data | Share activity data with care team. Participants will have sensor technology installed in their home and caregivers will be provided with the data via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors. Share activity data with care team: Share participant in-home activity data with retirement community care team. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants With Increased Need for Assistance During 3-year Study Period | Self-reported endorsement to the question "In the past week, is someone newly assisting you with medication management, bathing, dressing or grooming?" OR permanent move from independent living to assisted living or to a health care center | Ninety-one participants were enrolled and randomized. | Posted | Count of Participants | Participants | 3 years |
|
Three year study period.
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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 | Shared Data | Share activity data with care team. Participants will have sensor technology installed in their home and caregivers will be provided with the data via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors. Share activity data with care team: Share participant in-home activity data with retirement community care team. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Kaye | Oregon Health & Science University | 503 494 6695 | kaye@ohsu.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 | Nov 26, 2014 | Jun 22, 2021 | Prot_SAP_000.pdf |
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| 28877864 | Background | Austin J, Hollingshead K, Kaye J. Internet Searches and Their Relationship to Cognitive Function in Older Adults: Cross-Sectional Analysis. J Med Internet Res. 2017 Sep 6;19(9):e307. doi: 10.2196/jmir.7671. |
| 28731434 | Background | Seelye A, Mattek N, Sharma N, Witter P, Brenner A, Wild K, Dodge H, Kaye J. Passive Assessment of Routine Driving with Unobtrusive Sensors: A New Approach for Identifying and Monitoring Functional Level in Normal Aging and Mild Cognitive Impairment. J Alzheimers Dis. 2017;59(4):1427-1437. doi: 10.3233/JAD-170116. |
| 28349120 | Background | Austin J, Klein K, Mattek N, Kaye J. Variability in medication taking is associated with cognitive performance in nondemented older adults. Alzheimers Dement (Amst). 2017 Mar 6;6:210-213. doi: 10.1016/j.dadm.2017.02.003. eCollection 2017. |
| 31148911 | Background | Kaye J. Making Pervasive Computing Technology Pervasive for Health & Wellness in Aging. Public Policy Aging Rep. 2017;27(2):53-61. doi: 10.1093/ppar/prx005. Epub 2017 Jun 9. No abstract available. |
| 27574577 | Background | Austin J, Dodge HH, Riley T, Jacobs PG, Thielke S, Kaye J. A Smart-Home System to Unobtrusively and Continuously Assess Loneliness in Older Adults. IEEE J Transl Eng Health Med. 2016 Jun 10;4:2800311. doi: 10.1109/JTEHM.2016.2579638. eCollection 2016. |
| 26967228 | Background | Silbert LC, Dodge HH, Lahna D, Promjunyakul NO, Austin D, Mattek N, Erten-Lyons D, Kaye JA. Less Daily Computer Use is Related to Smaller Hippocampal Volumes in Cognitively Intact Elderly. J Alzheimers Dis. 2016;52(2):713-7. doi: 10.3233/JAD-160079. |
| 26878035 | Background | Seelye A, Hagler S, Mattek N, Howieson DB, Wild K, Dodge HH, Kaye JA. Computer mouse movement patterns: A potential marker of mild cognitive impairment. Alzheimers Dement (Amst). 2015 Dec 1;1(4):472-480. doi: 10.1016/j.dadm.2015.09.006. Epub 2015 Oct 19. |
| 26437228 | Background | Petersen J, Austin D, Mattek N, Kaye J. Time Out-of-Home and Cognitive, Physical, and Emotional Wellbeing of Older Adults: A Longitudinal Mixed Effects Model. PLoS One. 2015 Oct 5;10(10):e0139643. doi: 10.1371/journal.pone.0139643. eCollection 2015. |
| 26191967 | Background | Seelye A, Mattek N, Howieson DB, Austin D, Wild K, Dodge HH, Kaye JA. Embedded Online Questionnaire Measures Are Sensitive to Identifying Mild Cognitive Impairment. Alzheimer Dis Assoc Disord. 2016 Apr-Jun;30(2):152-9. doi: 10.1097/WAD.0000000000000100. |
| 26113819 | Background | Lyons BE, Austin D, Seelye A, Petersen J, Yeargers J, Riley T, Sharma N, Mattek N, Wild K, Dodge H, Kaye JA. Pervasive Computing Technologies to Continuously Assess Alzheimer's Disease Progression and Intervention Efficacy. Front Aging Neurosci. 2015 Jun 10;7:102. doi: 10.3389/fnagi.2015.00102. eCollection 2015. |
| 25642948 | Background | Seelye A, Mattek N, Howieson D, Riley T, Wild K, Kaye J. The impact of sleep on neuropsychological performance in cognitively intact older adults using a novel in-home sensor-based sleep assessment approach. Clin Neuropsychol. 2015;29(1):53-66. doi: 10.1080/13854046.2015.1005139. Epub 2015 Feb 2. |
| 33439144 | Result | Wild K, Sharma N, Mattek N, Karlawish J, Riley T, Kaye J. Application of In-Home Monitoring Data to Transition Decisions in Continuing Care Retirement Communities: Usability Study. J Med Internet Res. 2021 Jan 13;23(1):e18806. doi: 10.2196/18806. |
| BG001 | Non-shared Data | Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Non-shared Data | Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors. |
|
|
| 5 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Non-shared Data | Participants will have sensor technology installed in their home and caregivers will NOT have data provided via our caregiver tool. This group will be newly enrolled as part of this study and randomized to either the shared data or non-shared data groups. Randomization will be stratified by continuing care retirement community site and include statistical balancing on demographic factors. | 7 | 48 | 0 | 48 | 0 | 48 |
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