Socially Isolated Older Adults Living With Dementia

NCT03666624 | Completed Results DMC

• 2 other identifiers: STUDY000051495P30AG034592-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia

Keywords

LGBT

Outcome Measures

Primary Outcomes (2)

• Change in Physical Activity

  Minutes spent on exercising per week in the past month were calculated from the following two questions: (1) How much time did you spend on exercises (hours per day) on a typical day during the last month; (2) How many days did you spend on exercises during the last month.

  Baseline (pre-treatment) and 7 weeks (post-treatment)

• Change in Physical Functioning

  Physical Functioning subscale of the Medical Outcomes Study 36-Item Short Form (SF-36) consists of 10 items and measures how much participants' health status limits their activities including walking, climbing, lifting, and bathing or dressing oneself, based on self-reports. Each item is measured a 3-point scale (1 = Yes, limited a lot; 2 = Yes, limited a little; 3 = No, not limited at all), then recoded into 0, 50, and 100, respectively. The recoded scores are averaged to generate a summary score with its possible range from 0 to 100. Higher scores indicate better physical functioning.

  Baseline (pre-treatment) and 7 weeks (post-treatment)

Secondary Outcomes (1)

• Change in Quality of Life

  Baseline (pre-treatment) and 7 weeks (post-treatment)

Study Arms (2)

Personalized care network

EXPERIMENTAL

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

Behavioral: Personalized care network

Routine medical care

NO INTERVENTION

No intervention

Interventions

Personalized care network BEHAVIORAL

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

Personalized care network

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UWashington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Karen Fredriksen Goldsen
• Organization: University of Washington

fredrikk@uw.edu

206-543-5722

Study Officials

• Hyun-Jun Kim, PhD

  University of Washington

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: This study will utilize a 2-group randomized controlled trial design including 2 assessments, i.e. a pre-treatment and a post-treatment.

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 12, 2018
• Study Start: August 6, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 2, 2022
• Results First Posted: February 2, 2022

Record last verified: 2022-01

Locations

US (1)