Socially Isolated Older Adults Living With Dementia

• ClinicalTrials.gov Identifier: NCT03666624
• Recruitment Status: Completed
• First Posted: September 12, 2018
• Results First Posted: February 2, 2022
• Last Update Posted: February 2, 2022
• Sponsor: University of Washington
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Hyun-Jun Kim, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; Dementia	Behavioral: Personalized care network	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Socially Isolated Older Adults Living With Dementia
• Actual Study Start Date: August 6, 2020
• Actual Primary Completion Date: December 30, 2020
• Actual Study Completion Date: December 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Personalized care network; 9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks	Behavioral: Personalized care network; The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
No Intervention: Routine medical care; No intervention

Outcome Measures

Primary Outcome Measures :

1. Change in Physical Activity [ Time Frame: Baseline (pre-treatment) and 7 weeks (post-treatment) ]
   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.
2. Change in Physical Functioning [ Time Frame: Baseline (pre-treatment) and 7 weeks (post-treatment) ]
   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.

Secondary Outcome Measures :

1. Change in Quality of Life [ Time Frame: Baseline (pre-treatment) and 7 weeks (post-treatment) ]
   Quality of Life in Alzheimer's Disease (QOL-AD) is a 13-item scale that measures participant's self-reported feelings about different aspects of life including energy, mood, living situation, memory, family, friends, ability, and money. Each item has a 4-point response scale (1 = poor; 2 = fair; 3 = good; 4 = excellent). The summary score is a sum of the 13 items with its possible range from 13 to 52. Higher scores indicate higher quality of life.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Washington

UWashington

Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

National Institute on Aging (NIA)

Investigators

• Study Director: Hyun-Jun Kim, PhD; University of Washington

  Study Documents (Full-Text)

Documents provided by Hyun-Jun Kim, University of Washington:

Study Protocol and Statistical Analysis Plan  [PDF] September 22, 2020

More Information

• Responsible Party: Hyun-Jun Kim, Research Assistant Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT03666624
• Other Study ID Numbers: STUDY00005149; 5P30AG034592-05 ( U.S. NIH Grant/Contract )
• First Posted: September 12, 2018
• Results First Posted: February 2, 2022
• Last Update Posted: February 2, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hyun-Jun Kim, University of Washington:

LGBT

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders