Socially Isolated Older Adults Living With Dementia

NCT ID: NCT03666624

Last Updated: 2022-02-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-06

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will utilize a 2-group randomized controlled trial design including 2 assessments, i.e. a pre-treatment and a post-treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Personalized care network

9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks

Group Type EXPERIMENTAL

Personalized care network

Intervention Type BEHAVIORAL

The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.

Routine medical care

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Personalized care network

The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Jun Kim

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun-Jun Kim, PhD

Role: STUDY_DIRECTOR

University of Washington

Locations

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UWashington

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5P30AG034592-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005149

Identifier Type: -

Identifier Source: org_study_id

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