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Socially Isolated Older Adults Living With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03666624
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Hyun-Jun Kim, University of Washington

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 6, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020


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



Primary Outcome Measures :
  1. Change in Physical Activity of Care Recipient [ Time Frame: Baseline, 7 weeks ]
    # of minutes per week of exercise care recipient participated in

  2. Change in Physical Functioning of Care Recipient [ Time Frame: Baseline, 7 weeks ]
    # of days care recipient experienced restriction in activities


Secondary Outcome Measures :
  1. Change in Quality of Life of Care Recipient [ Time Frame: Baseline, 7 weeks ]
    Quality of Life in Alzheimer's Disease



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666624


Contacts
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Contact: Amy Cunningham, MS 206-543-8446 amoore@uw.edu
Contact: Charlotte Brown, BS 1-888-655-6646 cbrown25@uw.edu

Locations
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United States, Washington
UWashington Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Karen I Fredriksen-Goldsen, PhD         
Principal Investigator: Hyun-Jun Kim, PhD         
Principal Investigator: Linda Teri, PhD         
Sponsors and Collaborators
University of Washington
Investigators
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Study Director: Hyun-Jun Kim, PhD University of Washington
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Responsible Party: Hyun-Jun Kim, Research Scientist/Research Director, University of Washington
ClinicalTrials.gov Identifier: NCT03666624    
Other Study ID Numbers: STUDY00005149
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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