N/A
N=322
Innovations in Dementia Empowerment and Action
Alzheimer Disease · Dementia · Mild Cognitive Impairment · Parkinson Disease Dementia · Lewy Body Dementia
Bottom Line
View on ClinicalTrials.gov: NCT03550131 ↗Enrolled (actual)
322
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Physical Activity of Care Recipient — 3.20; 2.76; 3.01; 2.66 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Innovations in Dementia Empowerment and Action (IDEA) (Behavioral); Reducing Disabilities in Alzheimer's Disease (RDAD) (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Physical Activity of Care Recipient |
3.20; 2.76; 3.01; 2.66; 3.81; 3.79 | — |
| SECONDARY Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10) |
7.38; 6.98; 6.76; 6.95; 5.63; 6.38 | — |
| SECONDARY Quality of Life in Alzheimer's Disease, Care Recipient |
33.29; 34.71; 33.94; 34.07; 36.49; 35.37 | — |
| SECONDARY Memory-Related Disturbance, Care Recipient |
1.24; 1.19; 1.21; 1.15; 1.10; 1.10 | — |
| SECONDARY Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36) |
58.65; 58.46; 58.15; 59.16; 59.95; 61.24 | — |
| SECONDARY Perceived Stress of Care Partner |
2.39; 2.42; 2.46; 2.44; 2.44; 2.46 | — |
Summary
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).
Eligibility Criteria
Inclusion criteria for care receiver
- Age at enrollment is 50 years of age or older
- Have dementia, (e.g., Alzheimer's disease, mild cognitive impairment, Vascular dementia, Parkinson's disease, Lewy Body dementia) or memory loss significant enough to affect daily activities
- Living in the community, not in a care facility.
- Living in the U.S.
- Either the care receiver or care giver must self-identify as LGBT (or sexual or gender non-binary or same sex sexual behavior)
Inclusion criteria for care giver
- Provide care to the care recipient with dementia.
- Willing to spend 30 minutes daily for study activities (or coordinate for someone to.)
- Unpaid
- Live in the community, not in a care facility
- Living in the U.S.
Neither care receiver nor caregiver:
- Has known terminal illness (with death anticipated within the next 12 months)
- Was hospitalized for a psychiatric disorder in the 12 months prior to baseline
- Is currently suicidal or having major hallucinations or delusions
- Plans to move to long term care setting within 6 months of enrollment.
- Has any physical limitations/chronic conditions preventing participation in an exercise program.
Data sourced from ClinicalTrials.gov (NCT03550131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.