IDEA: Innovations in Dementia Empowerment and Action

Sponsor

University of Washington (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03550131

Collaborator

(none)

322

Enrollment

Location

Arms

41.8

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Dementia Mild Cognitive Impairment Parkinson Disease Dementia Lewy Body Dementia Vascular Dementia	Behavioral: Innovations in Dementia Empowerment and Action (IDEA) Behavioral: Reducing Disabilities in Alzheimer's Disease (RDAD)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

322 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

Aging With Pride: Innovations in Dementia Empowerment and Action

Actual Study Start Date :

Dec 5, 2018

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Physical Activity of Care Recipient [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
# of minutes per week of exercise care recipient participated in
Change in Physical Activity of Caregiver [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
# of minutes per week of exercise caregiver participated in
Change in Physical Functioning of Care Recipient [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
# of days care recipient experienced restriction in activities
Change in Physical Functioning of Caregiver [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
# of days caregiver experienced restriction in activities
Change in Perceived Stress (PSS) of Caregiver [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
14-item self-report measure designed to measure nonspecific, appraised stress during the past month

Secondary Outcome Measures

Change in Health-Related Quality of Life (HRQOL) of Care Recipient [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
Medical outcomes study short form (MOS SF-36)
Change in Health-Related Quality of Life (HRQOL) of Caregiver [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
Medical outcomes study short form (MOS SF-36)
Change in Quality of Life (QOL-AD) of Care Recipient [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
QOL-AD measure
Change in Health-Related Quality of Life (QOL-AD) of Caregiver [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
Medical outcomes study short form (MOS SF-36)
Change in Rate of Care-Recipient Behavioral Disturbances [Baseline, 6 weeks, 13 weeks, 30 weeks, 13 months]
Revised Memory and Behavior Problem Checklist (RMBPC) assess presence and frequency of memory, depressive, disruptive behavior and caregiver response

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria for care receiver

Age at enrollment is 50 years of age or older
Have dementia, (e.g., Alzheimer's disease, MCI, 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.