Clinical trial NCT03666624: Socially Isolated Older Adults Living With Dementia
Official title: Socially Isolated Older Adults Living With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: LGBT
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will utilize a 2-group randomized controlled trial design including 2 assessments, i.e. a pre-treatment and a post-treatment.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age at enrollment is 50 years of age or older
* Self-identify as LGBT (or sexual or gender non-binary or same sex sexual behavior)
* Have early stage dementia, including Alzheimer's disease or needs help with complex daily activities
* Living in the community, not in a care facility.

Exclusion Criteria:

* Known terminal illness (with death anticipated within the next 12 months)
* Hospitalization for a psychiatric disorder in the 12 months prior to baseline
* Have more than early stage dementia
* Any physical limitations/chronic conditions preventing participation in an exercise program.

Primary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline (pre-treatment) and 7 weeks (post-treatment)
measure: Change in Physical Functioning
timeFrame: Baseline (pre-treatment) and 7 weeks (post-treatment)
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline (pre-treatment) and 7 weeks (post-treatment)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UWashington
state: Washington
Study officials:
affiliation: University of Washington
name: Hyun-Jun Kim, PhD
role: STUDY_DIRECTOR
References: