Innovations in Dementia Empowerment and Action

Not Applicable

Completed

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

Interventions: Behavioral: Reducing Disabilities in Alzheimer's Disease (RDAD)
Behavioral: Innovations in Dementia Empowerment and Action (IDEA)

Registration Number: NCT03550131

Lead Sponsor: University of Washington

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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 322

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard intervention	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	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

Primary Outcome Measures

Name	Time	Method
Change in Physical Activity of Care Recipient	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.

Secondary Outcome Measures

Name	Time	Method
Memory-Related Disturbance, Care Recipient	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.
Depression of Care Partner: Center for Epidemiological Studies-Depression Scale (CESD-10)	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.
Quality of Life in Alzheimer's Disease, Care Recipient	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.
Perceived Stress of Care Partner	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.
Physical Functioning of Care Recipient: Medical Outcomes Study 36-Item Short Form (SF-36)	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.