- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03666624
Socially Isolated Older Adults Living With Dementia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- UWashington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
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No Intervention: Routine medical care
No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Physical Activity
Time Frame: Baseline (pre-treatment) and 7 weeks (post-treatment)
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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.
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Baseline (pre-treatment) and 7 weeks (post-treatment)
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Change in Physical Functioning
Time Frame: Baseline (pre-treatment) and 7 weeks (post-treatment)
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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.
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Baseline (pre-treatment) and 7 weeks (post-treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life
Time Frame: Baseline (pre-treatment) and 7 weeks (post-treatment)
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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.
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Baseline (pre-treatment) and 7 weeks (post-treatment)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Hyun-Jun Kim, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005149
- 5P30AG034592-05 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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