Alzheimer DiseaseNCT03666624
Socially Isolated Older Adults Living With Dementia
A study testing Personalized care network in people with Alzheimer Disease and Dementia, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Personalized care network
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Personalized care network
- Keywords
- LGBT
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized care networkBehavioural
The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
| Study group | Role | What they receive |
|---|---|---|
| Personalized care network | Experimental | 9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks Receives: Behavioral: Personalized care network |
| Routine medical care | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-treatment) and 7 weeks (post-treatment)
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.
Measured: Baseline (pre-treatment) and 7 weeks (post-treatment)
Secondary outcomes (1)
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.
Measured: Baseline (pre-treatment) and 7 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start6 Aug 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Hyun-Jun Kim, University of Washington
- Investigators
- Hyun-Jun Kim, PhD, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666624
- Sponsor's protocol ID
- STUDY00005149
- Other IDs
- 5P30AG034592-05
- Status last verified
- Jan 2022
- First submitted
- 7 Sep 2018
- Last updated
- 2 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socially Isolated Older Adults Living With Dementia
- ClinicalTrials.gov ID
- NCT03666624
- Acronym / sponsor ID
- STUDY00005149
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- LGBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Posted 2 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personalized care network | Experimental | Behavioral: Personalized care network9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks |
| Routine medical care | No intervention | –No intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized care networkThe Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges. | Behavioural | Personalized care network |
Primary outcome
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.
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.
1 secondary outcome
Change in Quality of Life
Time frame: Baseline (pre-treatment) and 7 weeks (post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun-Jun Kim, PhD study director
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized care network in people with Alzheimer Disease and Dementia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity (time frame: Baseline (pre-treatment) and 7 weeks (post-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.