Clinical trial NCT03550131: Innovations in Dementia Empowerment and Action
Official title: Aging With Pride: Innovations in Dementia Empowerment and Action
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Mild Cognitive Impairment
Parkinson Disease Dementia
Lewy Body Dementia
Vascular Dementia
Keywords: LGBT
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-06-08
Enrollment: 322
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

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.

Primary outcomes:
measure: Change in Physical Activity of Care Recipient
timeFrame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Secondary outcomes:
measure: Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)
timeFrame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
measure: Quality of Life in Alzheimer's Disease, Care Recipient
timeFrame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
measure: Memory-Related Disturbance, Care Recipient
timeFrame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
measure: Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)
timeFrame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
measure: Perceived Stress of Care Partner
timeFrame: Baseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Karen Fredriksen-Goldsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: