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Socially Isolated Older Adults Living With Dementia

Primary Purpose

Alzheimer Disease, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized care network
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring LGBT

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UWashington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Personalized care network

Routine medical care

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 7, 2018
Last Updated
January 3, 2022
Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03666624
Brief Title
Socially Isolated Older Adults Living With Dementia
Official Title
Socially Isolated Older Adults Living With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
Keywords
LGBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized care network
Arm Type
Experimental
Arm Description
9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks
Arm Title
Routine medical care
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Personalized care network
Intervention Description
The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
Primary Outcome Measure Information:
Title
Change in Physical Activity
Description
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.
Time Frame
Baseline (pre-treatment) and 7 weeks (post-treatment)
Title
Change in Physical Functioning
Description
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.
Time Frame
Baseline (pre-treatment) and 7 weeks (post-treatment)
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
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.
Time Frame
Baseline (pre-treatment) and 7 weeks (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Jun Kim, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
UWashington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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Socially Isolated Older Adults Living With Dementia

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