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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG055488-01A1 | 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 such vulnerable older adults with Alzheimer's disease and related dementias (AD/RD) and their caregivers (CGs) is a significant public health problem. Caregiving of sexual/gender minority older adults with AD/RD is of concern due to social stigma, marginalization, and isolation, which may be barriers to sustaining caregiving. It is necessary and timely to translate evidence-based culturally adaptable interventions for this underserved and stigmatized population. Reducing Disability in Alzheimer's Disease (RDAD) has been evaluated in a randomized controlled trial and has shown to successfully train community-dwelling CR (care receiver)-CG dyads to increase the physical activity and functioning of individuals with AD/RD and their CGs and to teach CGs techniques for managing behavioral symptoms of CRs. RDAD consequently decreases stress of CGs, delays institutionalization of CRs, and increases health related quality of life (HRQOL) of CRs and CGs. Thus, this study will evaluate the effect of the standard RDAD among lesbian, gay, bisexual, and transgender (LGBT) CRs with AD/RD and their CGs, and this study will test a personalized intervention tailored to better respond to distinct risks experienced by CGs and LGBT CRs with AD/RD, addressing unique sexual/gender minority CG risk factors (e.g., identity management, stigma-related adverse or traumatic life events, and lack of social support).
We will address the following aims:
Aim 1. Test the translation and enhancement of intervention designed to increase physical activities of older adult care receivers (CRs) with AD/RD and their CGs. Aim 2. Evaluate the short- and long-term effect of the standard and personalized intervention on primary (physical activity and functioning; perceived stress for CGs; independence/residential status (institutionalization) for CRs) and secondary outcomes (HRQOL; depressive symptomatology; behavioral disturbances for CRs). Aim 3. Test the moderating roles of CR-CG characteristics, including type of CR-CG relationship, sex, and severity of CR AD/RD, on the treatment effect of the standard and personalized intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard intervention | Active Comparator | Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months |
|
| Personalized intervention | Experimental | Innovations in Dementia Empowerment and Action (IDEA): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innovations in Dementia Empowerment and Action (IDEA) | Behavioral | The IDEA intervention has the same exposure to treatment as the RDAD intervention. The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older LGBT populations.These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support. All other aspects of the treatment are preserved. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity of Care Recipient | Measured by the days of aerobic activity for at least 30 minutes in the past week with higher numbers indicating more days of activity. | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | Assessed using the summed score on the 10-item Center for Epidemiological Studies-Depression Scale (CESD-10). Range of scores 0-27 with higher scores indicating higher levels of depression. | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
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Inclusion criteria for care receiver
Inclusion criteria for care giver
Neither care receiver nor caregiver:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Fredriksen-Goldsen, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41387197 | Derived | Fredriksen-Goldsen KI, Teri L, Kim HJ, Jones-Cobb B, LaFazia D, McKenzie G, Petros R, Jung H, Oswald AG, Hoy-Ellis C, Emlet C. Innovations in Dementia Empowerment and Action: RCT for Underserved Communities. J Am Geriatr Soc. 2026 Jan;74(1):119-131. doi: 10.1111/jgs.70189. Epub 2025 Dec 12. |
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A total of 161 dyad pairs (i.e., a person with dementia and their care partner) were enrolled and randomly assigned to either the personalized or standard arm.
Participants recruited from multiple sources using a multifaceted approach, including direct referrals from community agencies providing aging and health services using presentations, flyers, newsletters, and social media.
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| ID | Title | Description |
|---|---|---|
| FG000 | Personalized Intervention | Innovations in Dementia Empowerment and Action (IDEA): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Innovations in Dementia Empowerment and Action (IDEA): The IDEA intervention has the same exposure to treatment as the RDAD intervention. The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older lesbian, gay, bisexual, and transgender (LGBT) populations.These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support. All other aspects of the treatment are preserved. |
| FG001 | Standard Intervention | Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Reducing Disabilities in Alzheimer's Disease (RDAD): The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Personalized Intervention | Innovations in Dementia Empowerment and Action (IDEA): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Innovations in Dementia Empowerment and Action (IDEA): The IDEA intervention has the same exposure to treatment as the RDAD intervention. The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older LGBT populations.These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support. All other aspects of the treatment are preserved. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The overall number includes both care recipients and care partners. |
| 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 of Care Recipient | Measured by the days of aerobic activity for at least 30 minutes in the past week with higher numbers indicating more days of activity. | Posted | Mean | Standard Deviation | days | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
|
56 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 Intervention, Care Recipient | Innovations in Dementia Empowerment and Action (IDEA): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Innovations in Dementia Empowerment and Action (IDEA): The IDEA intervention has the same exposure to treatment as the RDAD intervention. The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older LGBT populations. These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support. All other aspects of the treatment are preserved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. 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 | Aug 26, 2021 | May 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Care Partner | Jul 9, 2021 | May 13, 2024 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Care Recipient | Jul 9, 2021 | May 13, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| D020961 | Lewy Body Disease |
| D015140 | Dementia, Vascular |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D016564 | Amyloid beta-Protein Precursor |
| ID | Term |
|---|---|
| D058227 | Amyloidogenic Proteins |
| D000682 | Amyloid |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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This study will utilize a 2-group randomized controlled trial design including 2 pre-intervention and 4 post-intervention assessments. The comparator group (standard intervention) will have 112 caregiver-care receiver dyads, and the experimental group (personalized intervention) will have 113 caregiver-care receiver dyads.
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Participants receiving intervention will not be informed whether it is the standard or personalized treatment.
|
|
| Reducing Disabilities in Alzheimer's Disease (RDAD) | Behavioral | The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver. |
|
|
| Quality of Life in Alzheimer's Disease, Care Recipient | Quality of life was evaluated using the summed score of the Quality of Life in Alzheimer's Disease (QOL-AD), a 13-item measure. Range of scores 13-52 with higher scores equal better quality of life. | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
| Memory-Related Disturbance, Care Recipient | Assessed using mean scores on the memory-related subscale (7 items) of the 24-item Revised Memory and Behavior Problem Checklist (RMBPC). Ranges 0 -3. Higher scores indicate higher memory-related behavioral disturbances. | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
| Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | Physical functioning was assessed using the mean score of the Physical Functioning subscale of the Medical Outcomes Study 36-Item Short Form (SF-36), consisting of 10 items asking about degree to which health status limits activities including walking, climbing, lifting, and bathing or dressing oneself. The summary score ranges from 0 to 100. Higher scores indicate higher physical functioning. | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
| Perceived Stress of Care Partner | Assessed with mean scores of the 4-item Perceived Stress Scale. The summary score ranges from 0 to 4. Higher scores indicate more stress. | Baseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 months |
| Illness of dyad member |
|
| Death of person with dementia |
|
| BG001 | Standard Intervention | Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Reducing Disabilities in Alzheimer's Disease (RDAD): The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | The overall number includes both care recipients and care partners. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The overall number includes both care recipients and care partners. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The overall number includes both care recipients and care partners. | Count of Participants | Participants |
|
| OG001 | Standard Intervention | Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Reducing Disabilities in Alzheimer's Disease (RDAD): The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver. |
|
|
| Secondary | Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) | Assessed using the summed score on the 10-item Center for Epidemiological Studies-Depression Scale (CESD-10). Range of scores 0-27 with higher scores indicating higher levels of depression. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
|
|
|
| Secondary | Quality of Life in Alzheimer's Disease, Care Recipient | Quality of life was evaluated using the summed score of the Quality of Life in Alzheimer's Disease (QOL-AD), a 13-item measure. Range of scores 13-52 with higher scores equal better quality of life. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
|
|
|
| Secondary | Memory-Related Disturbance, Care Recipient | Assessed using mean scores on the memory-related subscale (7 items) of the 24-item Revised Memory and Behavior Problem Checklist (RMBPC). Ranges 0 -3. Higher scores indicate higher memory-related behavioral disturbances. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
|
|
|
| Secondary | Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) | Physical functioning was assessed using the mean score of the Physical Functioning subscale of the Medical Outcomes Study 36-Item Short Form (SF-36), consisting of 10 items asking about degree to which health status limits activities including walking, climbing, lifting, and bathing or dressing oneself. The summary score ranges from 0 to 100. Higher scores indicate higher physical functioning. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months |
|
|
|
| Secondary | Perceived Stress of Care Partner | Assessed with mean scores of the 4-item Perceived Stress Scale. The summary score ranges from 0 to 4. Higher scores indicate more stress. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 months |
|
|
|
| 2 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Personalized Intervention, Care Partner | Innovations in Dementia Empowerment and Action (IDEA): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Innovations in Dementia Empowerment and Action (IDEA): The IDEA intervention has the same exposure to treatment as the RDAD intervention. The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older LGBT populations. These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support. All other aspects of the treatment are preserved. | 0 | 80 | 0 | 80 | 0 | 80 |
| EG002 | Standard Intervention, Care Recipient | Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Reducing Disabilities in Alzheimer's Disease (RDAD): The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver. | 4 | 76 | 0 | 76 | 0 | 76 |
| EG003 | Standard Intervention, Care Partner | Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Reducing Disabilities in Alzheimer's Disease (RDAD): The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver. | 0 | 76 | 0 | 76 | 0 | 76 |
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008565 |
| Membrane Proteins |
| D011498 | Protein Precursors |
| D058255 | Protease Nexins |
| D053491 | Proteinase Inhibitory Proteins, Secretory |
| Diverse |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 13 weeks |
|
| 30 weeks |
|
| 13 months |
|
| 13 weeks |
|
| 30 weeks |
|
| 13 months |
|
| 13 weeks |
|
| 30 weeks |
|
| 13 months |
|
| 13 weeks |
|
| 30 weeks |
|
| 13 months |
|
| 13 weeks |
|
| 30 weeks |
|
| 52 weeks |
|