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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG024978-17 | 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 the READyR II Study is to test a dynamic tailoring phase of a remote assessment for changing dementia-related care needs.
Unmet dementia-related care needs are highly prevalent, and are detrimental to the care dyad's (person with dementia and their family care partner) health, safety, mortality, and likelihood of nursing home placement. READyR II tests a dynamic tailoring phase of an intervention program that was previously developed to remotely assess dementia-related care needs using digital data on behavioral patterns (from sensors and wearables) in the home. READyR II follows participants who have completed READyR for a total of six months in order to detect anomalies in activity patterns that may indicate new and unforeseen care needs.
People who voluntarily decide to participate in this follow-up intervention study will be asked to continue participating with the in-home monitoring sensor platform, complete weekly questionnaires, and receive regular follow-up telephone calls from the study team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| READyR II A | Experimental | Continuous monitoring will be conducted and analyzed for anomaly detection. Participants in this arm will receive contact phone call when a potential change in care needs is indicated by an anomaly. |
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| READyR II B (comparison) | Active Comparator | Sensors will remain in the home but anomaly detection analysis will not be performed and contact phone calls will be at regular intervals without dynamic tailoring content. Standard educational content will instead be shared over the phone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| READyR II: A | Behavioral | Continuous monitoring for anomaly detection and contact phone call when a potential change in care needs is indicated by an anomaly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean difference effect sizes for pre-post change the care dyad's preparation for future care needs | The Preparation for Future Care Needs Scale (Short Form) assesses the degree to which an individual has engaged in planning for future care needs in late life using 15 items and 5 subscales representing distinct planning processes (awareness, gathering information, decision making, concrete planning, avoidance). Items are scored on a 5 point Likert scale with higher scores indicating greater preparation for future care needs. Sorensen, S., Chapman, B. P., Duberstein, P. R., Pinquart, M., & Lyness, J. M. (2017). Assessing future care preparation in late life: Two short measures. Psychol Assess, 29(12), 1480-1495. | Baseline compared with 18 weeks |
| Mean difference effect sizes for pre-post change in the care dyad's relationship quality | The Dyadic Relationship Scale assesses the positive dyadic interactions and negative dyadic strain experienced by caregivers (11 items) and care recipients (10 items). Items are averaged for a summary score that ranges from 0 to 3, with higher scores indicating more positive interactions in the relationship, or more relationship strain, respectively. Sebern, M.D. & Whitlatch, C.J. (2007). Dyadic Relationship Scale: A measure of the impact of the provision and receipt of family care. The Gerontologist, 47(6), 741-751. | Baseline compared with 18 weeks |
| Mean difference effect sizes for pre-post change in the amount of incongruence between the care partner's understanding of the care values of the person with dementia | The Care Values Scale assesses the importance of four care-related values to the person with dementia from the perspectives of the person with dementia and their care partner. Items for each of the four subscales are averaged for a summary score that ranges from 1 to 3, with higher scores indicating greater importance of the care value to the person with dementia. Miller LM, Whitlatch CJ, Lee CS, Caserta MS. Care Values in Dementia: Patterns of Perception and Incongruence Among Family Care Dyads. The Gerontologist. 2018. | Baseline compared with 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference effect sizes for pre-post change in the amount of care-related strain reported | Subjective strain from caregiving will be assessed among family care partners at baseline and follow-up assessments using the Zarit Burden Interview (ZBI), short-form (12 items). Scores range from 0-48 with higher scores indicating a greater degree of strain from providing care. | Baseline compared with 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent out of the home | Time spent out of home will be robustly and accurately measured through an algorithm using sensor (motion/contact) and actigraphy data. 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;10(10):e0139643. | Continuously over 18 weeks |
Inclusion Criteria:
Exclusion Criteria:
Family Care Partners
Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndsey M Miller, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
De-identified IPD will be available upon request to our Alzheimer's Disease Research Center
Supporting Information:
Time Frame:
Data will become available after completion of study and after publication of primary study aims.
Access Criteria:
Requests need to made to the PI at the Oregon Alzheimer's Disease Research Center (OARDC). A short data request form will need to be submitted to the OADRC.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 2, 2024 | |
| Reset | Feb 29, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2024 | Feb 29, 2024 |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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Dyads will be randomized (assigned by chance) to one of two groups: 1) READyR A or 2) READyR B
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Participants will all agree to the dynamic tailoring phase with remote monitoring and surveys, and will not know whether the phone calls are related to anomaly detection or are a control condition phone call.
| READyR II: B | Behavioral | Sensors will remain in the home but anomaly detection analysis will not be performed and contact phone calls will be at regular intervals without dynamic tailoring content. |
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| Mean difference effect sizes for pre-post change in the care dyad's quality of life | The Quality of Life: Alzheimer's Disease Scale assesses individual perceptions of quality of life (from poor to excellent) across 13 items. Items are averaged for a summary score of 1 to 4, higher scores indicating greater degree of quality of life. Logsdon, R. G., Gibbons, L. E., McCurry, S. M., & Teri, L. (1999). Quality of Life in Alzheimer's Disease: Patient and Caregiver Reports. Journal of Mental Health and Aging, 5(1), 21-32. | Baseline compared with 18 weeks |
| Mean difference effect sizes for pre-post change in the care dyad's concealment of emotions | The Emotional Intimacy Disruptive Behavior Scale (8 items) assesses the frequency of engagement in behaviors to conceal emotions about an illness from one's partner. Druley, J. A., Stephens, M. A. P., & Coyne, J. C. (1997). Emotional and physical intimacy in coping with Lupus: Women's dilemmas of disclosure and approach. Health Psychology, 16, 506-514. | Baseline compared with 18 weeks |
| Physical activity / sedentary behavior | Physical activity and sedentary bouts will be measured using actigraphy data. | Continuously over 18 weeks |
| Time spent together / separate | Time spent together/separate as a dyad will be observed through previously-developed algorithms using data from PIR motion/contact sensors and actigraphy. We will consider times when the informal care dyad is together in the same room, separate within/outside of the home, and time in bathroom together (indicating ADL dependency). | Continuously over 18 weeks |
| Sleep patterns | Sleep patterns be measured using actigraphy, motion sensors, and a bed mat sensor. | Continuously over 18 weeks |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |