Innovations in Dementia Empowerment and Action

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2023-05-16

Brief Summary

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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).

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Detailed Description

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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

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Alzheimer Disease Dementia Mild Cognitive Impairment Parkinson Disease Dementia Lewy Body Dementia Vascular Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants receiving intervention will not be informed whether it is the standard or personalized treatment.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Reducing Disabilities in Alzheimer's Disease (RDAD)

Intervention Type BEHAVIORAL

The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.

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

Group Type EXPERIMENTAL

Innovations in Dementia Empowerment and Action (IDEA)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Personalized RDAD Standard RDAD

Eligibility Criteria

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Inclusion Criteria

* 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.
* 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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes