Innovations in Dementia Empowerment and Action (IDEA)

July 1, 2024 updated by: Karen Fredriksen Goldsen, University of Washington

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria for care receiver

  • 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)

Inclusion criteria for care giver

  • Provide care to the care recipient with dementia.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard intervention

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
Behavioral: Reducing Disabilities in Alzheimer's Disease (RDAD)
The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.
Other Names:
  • Standard RDAD
Experimental: Personalized intervention

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
Behavioral: Innovations in Dementia Empowerment and Action (IDEA)
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.
Other Names:
  • Personalized RDAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks(pre-treatment), 13 weeks(post-treatment), 30 weeks, 13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
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
Assessed with mean scores of the 4-item Perceived Stress Scale. The summary score ranges from 0 to 4. Higher scores indicate more stress.
Baseline, 6 weeks (Pre-treatment), 13 weeks (Post-treatment), 30 weeks, 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Karen Fredriksen-Goldsen, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2018

Primary Completion (Actual)

May 16, 2023

Study Completion (Actual)

May 16, 2023

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003076
  • 1R01AG055488-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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