Socially Isolated Older Adults Living With Dementia

Alzheimer Disease Clinical Trial

Official title:

Socially Isolated Older Adults Living With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666624
• Other study ID #: STUDY00005149
• Secondary ID: 5P30AG034592-05
• Status: Completed
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	UWashington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in Quality of Life	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.	Baseline (pre-treatment) and 7 weeks (post-treatment)