An interventional study of Personalized care network in Alzheimer Disease and Dementia, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-02-02.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks
Behavioral: Personalized care network
No intervention
The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
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.
Time frame: 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.
Time frame: Baseline (pre-treatment) and 7 weeks (post-treatment)
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.
Time frame: Baseline (pre-treatment) and 7 weeks (post-treatment)
| Milestone | Personalized Care Network | Routine Medical Care |
|---|---|---|
| Started | 15 | 15 |
| Completed | 14 | 15 |
| Not completed | 1 | 0 |
| Withdrew: Participant grieving over recent death of parent | 1 | 0 |
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.
| minutes per week | Personalized Care Network | Routine Medical Care |
|---|---|---|
| Unadjusted mean at baseline | 227 ± 69 | 282 ± 129 |
| Unadjusted mean at 7 weeks | 380 ± 105 | 232 ± 76 |
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.
| score on a scale | Personalized Care Network | Routine Medical Care |
|---|---|---|
| Unadjusted score at baseline | 66.1 ± 6.7 | 73.0 ± 6.1 |
| Unadjusted score at 7 weeks | 73.2 ± 7.3 | 72.0 ± 6.2 |
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.
| score on a scale | Personalized Care Network | Routine Medical Care |
|---|---|---|
| Unadjusted score at baseline | 30.9 ± 2.3 | 32.2 ± 1.8 |
| Unadjusted score at 7 weeks | 32.7 ± 3.3 | 32.0 ± 1.5 |
Collected over 9 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Personalized Care Network | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Routine Medical Care | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Personalized Care Network | Routine Medical Care | Total |
|---|---|---|---|
| Mean | 68.4 ± 1.8 | 68.8 ± 2.0 | 68.6 ± 1.3 |
| Sex: Female, Male(Participants) | Personalized Care Network | Routine Medical Care | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 9 | 11 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Personalized Care Network | Routine Medical Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 13 | 12 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Personalized Care Network | Routine Medical Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 10 | 11 | 21 |
| More than one race | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 1 | 1 |
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