Alzheimer DiseaseIDEANCT03550131

Innovations in Dementia Empowerment and Action

A study testing Innovations in Dementia Empowerment and Action (IDEA) and Reducing Disabilities in Alzheimer's Disease (RDAD) in people with Alzheimer Disease and Dementia, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease, Dementia, Mild Cognitive Impairment
What is being tested?: Innovations in Dementia Empowerment and Action (IDEA) and Reducing Disabilities in Alzheimer's Disease (RDAD)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 322 participants
Where: 1 siteUnited States
Study dates: 5 Dec 2018to 16 May 2023
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age at enrollment is 50 years of age or older
Have dementia, (e.g., Alzheimer's disease, mild cognitive impairment, Vascular dementia, Parkinson's disease, Lewy Body dementia) or memory loss significant enough to affect daily activities
Living in the community, not in a care facility.
Living in the U.S.
Either the care receiver or care giver must self-identify as LGBT (or sexual or gender non-binary or same sex sexual behavior)
Provide care to the care recipient with dementia.

Show all 16Show fewer

Willing to spend 30 minutes daily for study activities (or coordinate for someone to.)
Unpaid
Live in the community, not in a care facility
Living in the U.S.
Neither care receiver nor caregiver:
Has known terminal illness (with death anticipated within the next 12 months)
Was hospitalized for a psychiatric disorder in the 12 months prior to baseline
Is currently suicidal or having major hallucinations or delusions
Plans to move to long term care setting within 6 months of enrollment.
Has any physical limitations/chronic conditions preventing participation in an exercise program.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Aging With Pride: Innovations in Dementia Empowerment and Action

The lack of efficacious research-based interventions for such vulnerable older adults with Alzheimer's disease and related dementias (AD/RD) and their caregivers (CGs) is a significant public health problem. Caregiving of sexual/gender minority older adults with AD/RD is of concern due to social stigma, marginalization, and isolation, which may be barriers to sustaining caregiving. It is necessary and timely to translate evidence-based culturally adaptable interventions for this underserved and stigmatized population. Reducing Disability in Alzheimer's Disease (RDAD) has been evaluated in a randomized controlled trial and has shown to successfully train community-dwelling CR (care receiver)-CG dyads to increase the physical activity and functioning of individuals with AD/RD and their CGs and to teach CGs techniques for managing behavioral symptoms of CRs. RDAD consequently decreases stress of CGs, delays institutionalization of CRs, and increases health related quality of life (HRQOL) of CRs and CGs. Thus, this study will evaluate the effect of the standard RDAD among lesbian, gay, bisexual, and transgender (LGBT) CRs with AD/RD and their CGs, and this study will test a personalized intervention tailored to better respond to distinct risks experienced by CGs and LGBT CRs with AD/RD, addressing unique sexual/gender minority CG risk factors (e.g., identity management, stigma-related adverse or traumatic life events, and lack of social support).

Read the detailed description

We will address the following aims:

Aim 1. Test the translation and enhancement of intervention designed to increase physical activities of older adult care receivers (CRs) with AD/RD and their CGs. Aim 2. Evaluate the short- and long-term effect of the standard and personalized intervention on primary (physical activity and functioning; perceived stress for CGs; independence/residential status (institutionalization) for CRs) and secondary outcomes (HRQOL; depressive symptomatology; behavioral disturbances for CRs). Aim 3. Test the moderating roles of CR-CG characteristics, including type of CR-CG relationship, sex, and severity of CR AD/RD, on the treatment effect of the standard and personalized intervention.

Conditions: Alzheimer Disease, Dementia, Mild Cognitive Impairment, Parkinson Disease Dementia, Lewy Body Dementia, Vascular Dementia
Being tested: Innovations in Dementia Empowerment and Action (IDEA), Reducing Disabilities in Alzheimer's Disease (RDAD)
Keywords: LGBT
Medical subject headings: Alzheimer Disease, Dementia, Cognitive Dysfunction, Lewy Body Disease, Dementia, Vascular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Innovations in Dementia Empowerment and Action (IDEA)Behavioural
Also called Personalized RDAD
The IDEA intervention has the same exposure to treatment as the RDAD intervention. The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older LGBT populations.These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support. All other aspects of the treatment are preserved.
Reducing Disabilities in Alzheimer's Disease (RDAD)Behavioural
Also called Standard RDAD
The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.

Study groups in NCT03550131
Study group	Role	What they receive
Standard intervention	Active comparator	Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Receives: Behavioral: Reducing Disabilities in Alzheimer's Disease (RDAD)
Personalized intervention	Experimental	Innovations in Dementia Empowerment and Action (IDEA): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months Receives: Behavioral: Innovations in Dementia Empowerment and Action (IDEA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Physical Activity of Care Recipient
Measured by the days of aerobic activity for at least 30 minutes in the past week with higher numbers indicating more days of activity.
Measured: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

Secondary outcomes (5)

Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)
Assessed using the summed score on the 10-item Center for Epidemiological Studies-Depression Scale (CESD-10). Range of scores 0-27 with higher scores indicating higher levels of depression.
Measured: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Quality of Life in Alzheimer's Disease, Care Recipient
Quality of life was evaluated using the summed score of the Quality of Life in Alzheimer's Disease (QOL-AD), a 13-item measure. Range of scores 13-52 with higher scores equal better quality of life.
Measured: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Memory-Related Disturbance, Care Recipient
Assessed using mean scores on the memory-related subscale (7 items) of the 24-item Revised Memory and Behavior Problem Checklist (RMBPC). Ranges 0 -3. Higher scores indicate higher memory-related behavioral disturbances.
Measured: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)
Physical functioning was assessed using the mean score of the Physical Functioning subscale of the Medical Outcomes Study 36-Item Short Form (SF-36), consisting of 10 items asking about degree to which health status limits activities including walking, climbing, lifting, and bathing or dressing oneself. The summary score ranges from 0 to 100. Higher scores indicate higher physical functioning.
Measured: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Perceived Stress of Care Partner
Assessed with mean scores of the 4-item Perceived Stress Scale. The summary score ranges from 0 to 4. Higher scores indicate more stress.
Measured: Baseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201816 May 2023

First posted8 Jun 2018
Study start5 Dec 2018
Primary completion16 May 2023
Study completion16 May 2023

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.
Publications (1)Papers the sponsor has linked to this study.
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 pre-intervention and 4 post-intervention assessments. The comparator group (standard intervention) will have 112 caregiver-care receiver dyads, and the experimental group (personalized intervention) will have 113 caregiver-care receiver dyads.
Masking: Single blind
Who is masked: Participant
Enrolment: 322 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03550131
Sponsor's protocol ID: STUDY00003076
Other IDs: 1R01AG055488-01A1
Acronym: IDEA
Status last verified: Jul 2024
First submitted: 6 Apr 2018
Last updated: 25 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Fredriksen-Goldsen KI, Teri L, Kim HJ, Jones-Cobb B, LaFazia D, McKenzie G, Petros R, Jung H, Oswald AG, Hoy-Ellis C, Emlet C. Innovations in Dementia Empowerment and Action: RCT for Underserved Communities. J Am Geriatr Soc. 2026 Jan;74(1):119-131. doi: 10.1111/jgs.70189. Epub 2025 Dec 12.
PubMed 41387197

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aging With Pride: Innovations in Dementia Empowerment and Action
ClinicalTrials.gov ID: NCT03550131
Acronym / sponsor ID: IDEA / STUDY00003076
Conditions: Alzheimer Disease, Dementia, Mild Cognitive Impairment, Parkinson Disease Dementia, Lewy Body Dementia, Vascular Dementia
Keywords: LGBT
Study type: Interventional
Recruitment status: Completed
Enrolment: 322 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 5 Dec 2018 (actual)
Primary completion: 16 May 2023 (actual)
Study completion: 16 May 2023 (actual)
First posted: 8 Jun 2018 (actual)
Results: Posted 25 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

We will address the following aims:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This study will utilize a 2-group randomized controlled trial design including 2 pre-intervention and 4 post-intervention assessments. The comparator group (standard intervention) will have 112 caregiver-care receiver dyads, and the experimental group (personalized intervention) will have 113 caregiver-care receiver dyads.

Arm	Type	Receives
Standard intervention	Active comparator	Behavioral: Reducing Disabilities in Alzheimer's Disease (RDAD)Reducing Disabilities in Alzheimer's Disease (RDAD): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months
Personalized intervention	Experimental	Behavioral: Innovations in Dementia Empowerment and Action (IDEA)Innovations in Dementia Empowerment and Action (IDEA): 9 60-minute virtual sessions for 6 weeks and 4 15-minute follow-up phone sessions for 4 months

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Age at enrollment is 50 years of age or older
Have dementia, (e.g., Alzheimer's disease, mild cognitive impairment, Vascular dementia, Parkinson's disease, Lewy Body dementia) or memory loss significant enough to affect daily activities
Living in the community, not in a care facility.
Living in the U.S.
Either the care receiver or care giver must self-identify as LGBT (or sexual or gender non-binary or same sex sexual behavior)

Key exclusion criteria (0 listed)

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
Innovations in Dementia Empowerment and Action (IDEA)Also: Personalized RDADThe IDEA intervention has the same exposure to treatment as the RDAD intervention. The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older LGBT populations.These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support. All other aspects of the treatment are preserved.	Behavioural	Personalized intervention
Reducing Disabilities in Alzheimer's Disease (RDAD)Also: Standard RDADThe RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.	Behavioural	Standard intervention

Primary outcome

Change in Physical Activity of Care Recipient
Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Measured by the days of aerobic activity for at least 30 minutes in the past week with higher numbers indicating more days of activity.

5 secondary outcomes

Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)
Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Quality of Life in Alzheimer's Disease, Care Recipient
Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Memory-Related Disturbance, Care Recipient
Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)
Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months
Perceived Stress of Care Partner
Time frame: Baseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 months

Results and safety

Results posted to the registry on 25 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Personalized Intervention	162	96
Standard Intervention	160	98

Primary outcome: Change in Physical Activity of Care Recipient

Time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months. Mean (Standard Deviation). Unit: days

Measure	Personalized Intervention n = 80	Standard Intervention n = 76
Baseline	3.20 (2.56)	2.76 (2.53)
6 weeks	3.01 (2.66)	2.66 (2.53)
13 weeks	3.81 (2.40)	3.79 (2.54)
30 weeks	3.67 (2.67)	3.21 (2.60)
13 months	2.96 (2.51)	2.96 (2.51)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 56 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Personalized Intervention, Care Recipient	0 of 80 (0%)	0 of 80 (0%)	2 of 80
Personalized Intervention, Care Partner	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Standard Intervention, Care Recipient	0 of 76 (0%)	0 of 76 (0%)	4 of 76
Standard Intervention, Care Partner	0 of 76 (0%)	0 of 76 (0%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41387197Fredriksen-Goldsen KI, Teri L, Kim HJ, Jones-Cobb B, LaFazia D, McKenzie G, Petros R, Jung H, Oswald AG, Hoy-Ellis C, Emlet C. Innovations in Dementia Empowerment and Action: RCT for Underserved Communities. J Am Geriatr Soc. 2026 Jan;74(1):119-131. doi: 10.1111/jgs.70189. Epub 2025 Dec 12.

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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.

Karen Fredriksen-Goldsen, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 0 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 25 Jul 2024. 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 25 Jul 2024). 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 of Care Recipient (time frame: Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03550131, which also lists 1 linked publication.

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 25 Jul 2024.