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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG034592-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The lack of efficacious research-based interventions for sexual and gender minority (SGM) older adults living with Alzheimer's disease and other dementias, combined with the heightened risk of cognitive impairment in this population, presents a significant public health problem. SGM older adults are at elevated risk of social isolation and experience significant barriers to healthcare access. Existing interventions for older adults with dementia have been found to be effective for caregiving dyads. Yet SGM older adults, compared to heterosexuals, are significantly less likely to be married or to have biological family members to support them. A significant proportion of SGM older adults living with dementia have no caregiver or care network. The goal of the proposed research is to design and pilot test the cultural appropriateness, acceptability, and feasibility of an innovative translation of a personalized care network-RDAD (Reducing Disability in Alzheimer's Disease) to support those living with dementia without a family caregiver, directly addressing unique SGM-specific risk factors.
We will address the following aims:
Aim 1. Develop a personalized care network-RDAD intervention suitable for SGM older adults living with dementia without caregivers.
Aim 2. Implement a preliminary randomized controlled trial (RCT) of 30 participants with 2 arms (routine medical care vs. the personalized care network-RDAD approach) to assess the acceptability, feasibility, and initial efficacy of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized care network | Experimental | 9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks |
|
| Routine medical care | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized care network | Behavioral | The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity | Minutes spent on exercising per week in the past month were calculated from the following two questions: (1) How much time did you spend on exercises (hours per day) on a typical day during the last month; (2) How many days did you spend on exercises during the last month. | Baseline (pre-treatment) and 7 weeks (post-treatment) |
| Change in Physical Functioning | Physical Functioning subscale of the Medical Outcomes Study 36-Item Short Form (SF-36) consists of 10 items and measures how much participants' health status limits their activities including walking, climbing, lifting, and bathing or dressing oneself, based on self-reports. Each item is measured a 3-point scale (1 = Yes, limited a lot; 2 = Yes, limited a little; 3 = No, not limited at all), then recoded into 0, 50, and 100, respectively. The recoded scores are averaged to generate a summary score with its possible range from 0 to 100. Higher scores indicate better physical functioning. | Baseline (pre-treatment) and 7 weeks (post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Quality of Life in Alzheimer's Disease (QOL-AD) is a 13-item scale that measures participant's self-reported feelings about different aspects of life including energy, mood, living situation, memory, family, friends, ability, and money. Each item has a 4-point response scale (1 = poor; 2 = fair; 3 = good; 4 = excellent). The summary score is a sum of the 13 items with its possible range from 13 to 52. Higher scores indicate higher quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun-Jun Kim, PhD | University of Washington | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UWashington | Seattle | Washington | 98195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Personalized Care Network | 9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges. |
| FG001 | Routine Medical Care | No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Personalized Care Network | 9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges. |
| BG001 |
| 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 | Change in Physical Activity | Minutes spent on exercising per week in the past month were calculated from the following two questions: (1) How much time did you spend on exercises (hours per day) on a typical day during the last month; (2) How many days did you spend on exercises during the last month. | Posted | Mean | Standard Error | minutes per week | Baseline (pre-treatment) and 7 weeks (post-treatment) |
|
9 weeks
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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 | Personalized Care Network | 9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Fredriksen Goldsen | University of Washington | 206-543-5722 | fredrikk@uw.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 22, 2020 | Nov 30, 2021 | Prot_SAP_000.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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This study will utilize a 2-group randomized controlled trial design including 2 assessments, i.e. a pre-treatment and a post-treatment.
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| Baseline (pre-treatment) and 7 weeks (post-treatment) |
| Routine Medical Care |
No intervention |
| 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 |
|
No intervention |
|
|
| Primary | Change in Physical Functioning | Physical Functioning subscale of the Medical Outcomes Study 36-Item Short Form (SF-36) consists of 10 items and measures how much participants' health status limits their activities including walking, climbing, lifting, and bathing or dressing oneself, based on self-reports. Each item is measured a 3-point scale (1 = Yes, limited a lot; 2 = Yes, limited a little; 3 = No, not limited at all), then recoded into 0, 50, and 100, respectively. The recoded scores are averaged to generate a summary score with its possible range from 0 to 100. Higher scores indicate better physical functioning. | Posted | Mean | Standard Error | score on a scale | Baseline (pre-treatment) and 7 weeks (post-treatment) |
|
|
|
| Secondary | Change in Quality of Life | Quality of Life in Alzheimer's Disease (QOL-AD) is a 13-item scale that measures participant's self-reported feelings about different aspects of life including energy, mood, living situation, memory, family, friends, ability, and money. Each item has a 4-point response scale (1 = poor; 2 = fair; 3 = good; 4 = excellent). The summary score is a sum of the 13 items with its possible range from 13 to 52. Higher scores indicate higher quality of life. | Posted | Mean | Standard Error | score on a scale | Baseline (pre-treatment) and 7 weeks (post-treatment) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Routine Medical Care | No intervention | 0 | 15 | 0 | 15 | 0 | 15 |
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |